Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT02032433
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH), The Emmes Company, LLC (Industry)
• Enrollment: 570
• Locations: 8
• Arms: 2
• Actual Duration (Months): 36.1
• Patients Per Site: 71.3
• Patients Per Site Per Month: 2

Study Details

Study Description

Brief Summary

CTN-0051 assesses the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high affinity partial agonist indicated for maintenance treatment of opioid dependence, as pharmacotherapeutic aids to recovery.

The study is conducted in 8 NIDA Clinical Trials Network affiliated community based treatment programs. Up to 600 eligible participants will be randomized to treatment with XR-NTX or BUP-NX for 24 weeks (sufficient to include 350 participants who are randomized more than 72 hours after their last opioid).

The primary goal of the study is to estimate the difference, if one exists, between XR-NTX and BUP-NX in the distribution of the time to relapse (i.e.., loss of persistent abstinence) during the 6-month trial. Secondary objectives are to: (1) compare outcome on XR-NTX versus BUP-NX across a range of clinical safety and secondary efficacy domains, and (2) explore demographic and, clinical, and genetic predictors of successful treatment and moderators of differential effectiveness (i.e., what variables may help clinicians choose which of these treatments is best for a given patient).), and (3) collect a limited dataset to permit analyses of economic costs and benefits of the two treatments.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Disorder	Drug: Extended-Release Naltrexone; Drug: Buprenorphine-Naloxone	Phase 4

Detailed Description

For opioid-dependent patients in the U.S. and most of the rest of the world, detoxification or detoxification followed by short term residential treatment, with the goal of achieving long-term abstinence from opioid misuse is a mainstay of treatment. Nonetheless, the majority of patients treated in this way will relapse to opioid misuse, leading to a costly and ineffectual cycle of readmission for repeated detoxifications.

The overarching goal of CTN-0051 is to foster adoption of new relapse-prevention pharmacotherapies in community-based treatment programs (CTPs) where these could have a substantial public health impact. To this end CTN-0051 assesses the comparative effectiveness of extended release injectable naltrexone (XR-NTX, Vivitrol®), an opioid antagonist recently approved and indicated for the prevention of relapse to opioid dependence, versus buprenorphine-naloxone (BUP-NX, Suboxone®), a high affinity partial agonist indicated for maintenance treatment of opioid dependence, as pharmacotherapeutic aids to recovery.

The study is conducted in 8 CTN-affiliated CTPs that provide or partner with detoxification services (inpatient/residential) which have the capacity to maintain participants opioid-free for approximately 3-7 days, have the capacity to provide medication-assisted therapy, and can provide a minimum of one group or individual counseling session per week during the 24-week treatment period. Up to 600 eligible participants will be randomized to treatment with XR-NTX or BUP-NX for 24 weeks (sufficient to include 350 participants who are randomized more than 72 hours after their last opioid). To maximize generalizability, the point of randomization is flexible, from shortly after program admission until just prior to program discharge. A data analysis modification (assessment of whether the early vs. late randomizers have a differential treatment effect and if so, time to relapse will be estimated for early and late randomizers separately) will occur if differential treatment initiation is a problem for cases randomized prior to completing detoxification (i.e., significantly fewer early randomizers are able to complete detoxification and XR-NTX induction).

The primary goal of the study is to estimate the difference, if one exists, between XR-NTX and BUP-NX in the distribution of the time to relapse (i.e., loss of persistent abstinence) during the 6-month trial. The primary outcome measure will be the time to the event, with the event called relapse. Secondary objectives are to: (1) compare outcome on XR-NTX versus BUP-NX across a range of clinical safety and secondary efficacy domains, and (2) explore demographic and, clinical, and genetic predictors of successful treatment and moderators of differential effectiveness (i.e., what variables may help clinicians choose which of these treatments is best for a given patient), and (3) collect a limited dataset to permit analyses of economic costs and benefits of the two treatments.

Toward the end of the 24-week treatment period, participants are referred for follow-up care in the community (which could include pharmacotherapy if desired and available), and follow-up outcomes are assessed at week 28 and week 36 after randomization. For participants receiving BUP-NX, who do not wish to continue, or for whom community resources are not available, the study provides a two-week BUP-NX taper.

In an ancillary genetics study we plan to study functional variants in three genes (OPRM1, OPRK1 and PDYN), known to affect the dynamic response to opioid receptor ligands. These variants will be evaluated in CTN-0051 for their contribution to treatment retention, abstinence, and depression. Blood collection for DNA extraction will occur at the same time that blood is collected for medical safety and liver function evaluation, precluding the need for an additional needle-stick. Coded blood samples for the genetics studies will be sent to the NIDA Center for Genetics Repository.

Study Design

• Study Type: Interventional
• Actual Enrollment: 570 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: CTN-0051: Extended-Release Naltrexone vs. Buprenorphine for Opioid Treatment
• Actual Study Start Date: Jan 29, 2014
• Actual Primary Completion Date: Jan 25, 2017
• Actual Study Completion Date: Jan 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Extended-Release Naltrexone Extended-Release Naltrexone (Vivitrol)	Drug: Extended-Release Naltrexone; Extended-Release Naltrexone (Vivitrol®); Other Names: Vivitrol®
Active Comparator: Buprenorphine-Naloxone Buprenorphine-Naloxone (Suboxone)	Drug: Buprenorphine-Naloxone; Buprenorphine-Naloxone (Suboxone®); Other Names: Suboxone®

Outcome Measures

Primary Outcome Measures

1. Time to Relapse (Intent to Treat Population) [Weeks 3-24]

   Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.

2. Time to Relapse (Per Protocol Population) [Weeks 3-24]

   Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.

Secondary Outcome Measures

1. Number Successfully Inducted Onto Assigned Study Medication [Weeks 0-24]

   Binary Y/N assessment of whether the participant was or was not able to initiate their assigned study medication.

2. Adverse Events Related to Study Medications [Weeks 0-36]

   Adverse events reported by participants and assessed by clinical staff for relatedness to study medication. These determinations were reviewed by the study medical monitor.

3. Opioid Abstinence Over Time While on Study Medication (Subjective) [Weeks 0-24]

   Self report of opioid use by participants using the TLFB. At each visit, the TLFB was completed for dates going back to the last participant encounter.

4. Alcohol Use Over Time, Drinks Per Day, Past 30 Days, W0 [Week 0]

   Alcohol use over time, drinks per day, past 30 days, at week 0

5. Cigarette Smoking, W0, 10 or Less [Week 0]

   Participants average cigarettes/day, in past 4 weeks, at week 0, equals 10 or less.

6. Opioid Craving Over Time W0 [Week 0]

   Opioid craving over time via VAS at week 0

7. Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale [Week 0]

   The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression.

8. Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale [Week 0]

   The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.

9. Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS) [Week 0]

   The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior.

10. Score on Trail Making Test Part A [Week 0]

    Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment.

11. Opioid Abstinence Over Time While on Study Medication (Objective) [Weeks 0-24]

    A urine sample was obtained and tested for opioids at each in person visit; screening, prior to induction onto study medication, weekly through week 24 and at each of the follow up visits.

12. Cigarette Smoking, W0 0 [Week 0]

    Participants average cigarettes/day, in past 4 weeks, at week 0, equals none

13. Cigarette Smoking, W0 11-20 [Week 0]

    Participants average cigarettes/day, in past 4 weeks, at week 0, equals 11-20.

14. Cigarette Smoking, W0 21-30 [Week 0]

    Participants average cigarettes/day, in past 4 weeks, at week 0, equals 21-30

15. Cigarette Smoking, W0 31 or More [Week 0]

    Participants average cigarettes/day, in past 4 weeks, at week 0, equals 31 or more

16. Cigarette Smoking, W24 0 [Week 24]

    Participants average cigarettes/day, in past 4 weeks, at week 24, equals none

17. Cigarette Smoking [Week 24]

    Participants average cigarettes/day, in past 4 weeks, at week 24, equals 10 or less.

18. Cigarette Smoking, W24 11-20 [Week 24]

    Participants average cigarettes/day, in past 4 weeks, at week 24, equals 11-20.

19. Cigarette Smoking, W24 21-30 [Week 24]

    Participants average cigarettes/day, in past 4 weeks, at week 24, equals 21-30

20. Cigarette Smoking, W24 31 or More [Week 24]

    Participants average cigarettes/day, in past 4 weeks, at week 24, equals 31 or more

21. Score on Opioid Craving Scale (OCS) [Week 24]

    OCS is a brief 3-item measure used to measure opioid craving. The scale consists of 3 items rated on a visual analogue scale (VAS) from 1-10. The total range of score is 0-30, and a higher score indicates a stronger craver / desire to use opiates.

22. Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale [Week 24]

    The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression.

23. Score on Subjective Opiate Withdrawal Scale (SOWS) [Week 0]

    The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The total range of scores is 0-64; the higher the score, the more intense the withdrawal.

24. Score on Subjective Opiate Withdrawal Scale (SOWS) [Week 24]

    The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The total range of scores is 0-64; the higher the score, the more intense the withdrawal.

25. Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS) [Week 24]

    The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior.

26. Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS) [Week 0]

    The Sexual Behavior Subscale consists of 3 questions. Each question is scored from 0-5, for a total score range of 0-15. Higher scores indicate a greater degree of risk-taking behavior.

27. Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS) [Week 24]

    The Sexual Behavior Subscale consists of 3 questions. Each question is scored from 0-5, for a total score range of 0-15. Higher scores indicate a greater degree of risk-taking behavior.

28. Score on Trail Making Test Part A [Week 24]

    Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment.

29. Score on Trail Making Test Part B [Week 0]

    Part B consists of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern, by alternating between the numbers and letters. Results are reported as the number of seconds required to complete the task.

30. Score on Trail Making Test Part B [Week 24]

    Part B consists of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern, by alternating between the numbers and letters. Results are reported as the number of seconds required to complete the task.

31. Score on Word Card of Stoop Test [Week 0]

    The "word card" of the Stoop Test has the names of colors printed in black and white (100 items to be named). The patient's basic score is the total time he/she takes to utter the 100 words on the card.

32. Score on Word Card of Stoop Test [Week 24]

    The "word card" of the Stoop Test has the names of colors printed in black and white (100 items to be named). The patient's basic score is the total time he/she takes to utter the 100 words on the card.

33. Score on Color Card of Stoop Test [Week 0]

    The "color card" contains 100 patches of between 3-5 different colors. The patient's task is to utter the names of the colored patches as rapidly as possible, scanning the rows from left to right. The score is the total time (in seconds) it takes to utter the 100 colors.

34. Score on Color Card of Stoop Test [Week 24]

    The "color card" contains 100 patches of between 3-5 different colors. The patient's task is to utter the names of the colored patches as rapidly as possible, scanning the rows from left to right. The score is the total time (in seconds) it takes to utter the 100 colors.

35. Score on Color Word Card of Stoop Test [Week 0]

    The "color-word card" contains the printed names of colors, but printed in an ink of a conflicting color (e.g. the word RED might be printed in green, yellow, or blue). The patient is required to name the colors of the inks while ignoring the conflicting printed color names. The basic score is the total time (in seconds) to utter the 100 colors.

36. Score on Color Word Card of Stoop Test [Week 24]

    The "color-word card" contains the printed names of colors, but printed in an ink of a conflicting color (e.g. the word RED might be printed in green, yellow, or blue). The patient is required to name the colors of the inks while ignoring the conflicting printed color names. The basic score is the total time (in seconds) to utter the 100 colors.

37. Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale [Week 24]

    The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.

38. Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale [Week 0]

    The Drug Use Subscale within ASI is one question that asks how bothered one has been by drug use problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.

39. Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale [Week 24]

    The Drug Use Subscale within ASI is one question that asks how bothered one has been by drug use problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.

40. Score of Social Relationship Subscale Within Addiction Severity Index (ASI) Scale [Week 0]

    The Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem.

41. Score of Family / Social Relationship Subscale Within Addiction Severity Index (ASI) Scale [Week 24]

    The Family / Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem.

42. Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale [Week 0]

    The Legal Status Subscale within ASI is one question that asks how bothered one has been by legal problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.

43. Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale [Week 24]

    The Legal Status Subscale within ASI is one question that asks how bothered one has been by legal problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.

44. Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale [Week 0]

    The Medical Status Subscale within ASI is one question that asks how bothered one has been by medical problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.

45. Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale [Week 24]

    The Medical Status Subscale within ASI is one question that asks how bothered one has been by medical problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.

46. Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale [Week 0]

    The Psychiatric Status Subscale within ASI is one question that asks how bothered one has been by psychiatric or emotional problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.

47. Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale [Week 24]

    The Psychiatric Status Subscale within ASI is one question that asks how bothered one has been by psychiatric or emotional problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.

48. Score on EuroQOL EQ-5D Questionnaire [Week 0]

    Problems related to drug abuse is assessed through this questionnaire, which consists of 5 conditions. Each condition is scored from 0-2 for a total score range of 0-10. The higher the score, the more problems.

49. Score on EuroQOL EQ-5D Questionnaire [Week 24]

    Problems related to drug abuse is assessed through this questionnaire, which consists of 5 conditions. Each condition is scored from 0-2 for a total score range of 0-10. The higher the score, the more problems.

50. Alcohol Use Over Time, Drinks Per Day [Week 24]

    Alcohol use over time, drinks per day

51. Other Drug Use Over Time, Cannabis, W0 [week 0]

    Other drug use over time measuring cannabis at week 0

52. Other Drug Use Over Time, Cannabis, W24 [week 24]

    Other drug use over time measuring cannabis at week 24

53. Other Drug Use Over Time, Cocaine, W0 [week 0]

    Other drug use over time measuring cocaine at week 0

54. Other Drug Use Over Time, Cocaine, W24 [week 24]

    Other drug use over time measuring cocaine at week 0

55. Other Drug Use Over Time, Stimulant, W0 [week 0]

    Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 0

56. Other Drug Use Over Time, Stimulant, W24 [week 24]

    Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 24

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria

• Male or female

• 18 years of age and older

• Meet DSM-5 criteria for opioid-use disorder (heroin and/or prescription opioids)

• Have used opioids other than as specifically prescribed within thirty days prior to consent

• Seeking treatment for opioid dependence and willing to accept "agonist-based" or "antagonist-based" therapy

• In good-enough general health, as determined by the study physician on the basis of medical history, review of systems, physical exam and laboratory assessments, to permit treatment with XR-NTX or BUP-NX

• Able to provide written informed consent

• Able to speak English sufficiently to understand the study procedures and provide written informed consent to participate in the study

• If female of childbearing potential, be willing to practice an effective method of birth control for the duration of participation in the study

Exclusion Criteria

• Serious medical, psychiatric or substance use disorder that, in the opinion of the study physician, would make study participation hazardous to the participant, or compromise study findings or would prevent the participant from completing the study.

Examples include:

1. Disabling or terminal medical illness (e.g., uncompensated heart failure, cirrhosis or end-stage liver disease) as assessed by medical history, review of systems, physical exam and/or laboratory assessments;

2. Severe, untreated or inadequately treated mental disorder (e.g., active psychosis, uncontrolled manic-depressive illness) as assessed by history and/or clinical interview;

3. Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use likely to require a complicated medical detoxification (routine alcohol and sedative detoxifications may be included)

• LFTs (ALT, AST) greater than 5 times upper limit of normal

• Suicidal or homicidal ideation that requires immediate attention

• Known allergy or sensitivity to buprenorphine, naloxone, naltrexone, polylactide-co-glycolide, carboxymethylcellulose, or other components of the Vivitrol® diluent

• Maintenance on methadone at doses of 30mg or greater at the time of signing consent

• Presence of pain of sufficient severity as to require ongoing pain management with opioids

• Pending legal action or other reasons that might prevent an individual from completing the study

• If female, currently pregnant or breastfeeding, or planning on conception

• Body habitus that, in the judgment of the study physician, precludes safe intramuscular injection of XR-NTX (e.g., BMI>40, excess fat tissue over the buttocks, emaciation)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tarzana Treatment Centers	Tarzana	California	United States	91356
2	Gateway Community Services, Inc.	Jacksonville	Florida	United States	32201
3	Avery Road Treatment Center	Rockville	Maryland	United States	20853
4	Stanley Street Treatment and Resources	Fall River	Massachusetts	United States	02720
5	Turquoise Lodge Hospital	Albuquerque	New Mexico	United States	87108
6	Bellevue Hospital Center	New York	New York	United States	10016
7	Maryhaven	Columbus	Ohio	United States	43207
8	Evergreen Treatment Services	Seattle	Washington	United States	98134

Sponsors and Collaborators

• NYU Langone Health
• National Institute on Drug Abuse (NIDA)
• The Emmes Company, LLC

Investigators

• Principal Investigator: John Rotrosen, MD, NYU Langone Health

Study Documents (Full-Text)

• Study Protocol - Aug 31, 2015
• Statistical Analysis Plan - Apr 27, 2017

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02032433
• Other Study ID Numbers: 12-03133; UG1DA013035
• First Posted: Jan 10, 2014
• Last Update Posted: Aug 13, 2020
• Last Verified: Jul 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by NYU Langone Health: extended-release naltrexone (Vivitrol); buprenorphine-naloxone (Suboxone); comparative effective; relapse prevention
• Additional relevant MeSH terms: Opioid-Related Disorders; Naltrexone; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

Study Results

Participant Flow

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Period Title: Overall Study
STARTED	283	287
COMPLETED	205	225
NOT COMPLETED	78	62

Baseline Characteristics

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone	Total
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)	Total of all reporting groups
Overall Participants	283	287	570
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.0 (9.5)	33.7 (9.8)	33.9 (9.63)
Sex: Female, Male (Count of Participants)
Female	88 31.1%	81 28.2%	169 29.6%
Male	195 68.9%	206 71.8%	401 70.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	45 15.9%	54 18.8%	99 17.4%
Not Hispanic or Latino	238 84.1%	233 81.2%	471 82.6%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	2 0.7%	2 0.7%	4 0.7%
Asian	8 2.8%	1 0.3%	9 1.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	29 10.2%	28 9.8%	57 10%
White	206 72.8%	215 74.9%	421 73.9%
More than one race	18 6.4%	14 4.9%	32 5.6%
Unknown or Not Reported	20 7.1%	27 9.4%	47 8.2%
Randomization status (Count of Participants)
Early randomization	107 37.8%	110 38.3%	217 38.1%
Late randomization	176 62.2%	177 61.7%	353 61.9%

Outcome Measures

1. Primary Outcome

Title	Time to Relapse (Intent to Treat Population)
Description	Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.
Time Frame	Weeks 3-24

Outcome Measure Data

Analysis Population Description

Intention to treat.

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Median (95% Confidence Interval) [weeks]	8.4	14.4

2. Primary Outcome

Title	Time to Relapse (Per Protocol Population)
Description	Relapse occurs if the participant is using any non-protocol prescribed opioids regularly starting at day 21 post-randomization or thereafter. Operationally, relapse is defined as either: (a) four consecutive opioid use weeks, or (b) seven consecutive days of use by self-report. A use week is defined as any week during which a participant self-reports at least one day of use during that week, provides a urine sample positive for non-protocol opioids, or fails to provide a urine sample. Self-report of opioid (heroin or prescription opioids) and other substance use is ascertained at each weekly study visit using the Timeline Follow-Back for each day leading back to the previous visit. Urine is collected at each study visit and tested for opioids. A missed UDS counts as a use week.
Time Frame	Weeks 3-24

Outcome Measure Data

Analysis Population Description

Per protocol population (those successfully inducted onto medication)

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	204	270
Median (95% Confidence Interval) [weeks]	20.4	15.2

3. Secondary Outcome

Title	Number Successfully Inducted Onto Assigned Study Medication
Description	Binary Y/N assessment of whether the participant was or was not able to initiate their assigned study medication.
Time Frame	Weeks 0-24

Outcome Measure Data

Analysis Population Description

Intent to treat

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Number [participants]	204 72.1%	270 94.1%

4. Secondary Outcome

Title	Adverse Events Related to Study Medications
Description	Adverse events reported by participants and assessed by clinical staff for relatedness to study medication. These determinations were reviewed by the study medical monitor.
Time Frame	Weeks 0-36

Outcome Measure Data

Analysis Population Description

These are treatment emergent adverse events. Treatment emergence is defined as any adverse events that occurred after the study day of induction for those participants inducted onto study medication.

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	204	270
Number [events]	115	113

5. Secondary Outcome

Title	Opioid Abstinence Over Time While on Study Medication (Subjective)
Description	Self report of opioid use by participants using the TLFB. At each visit, the TLFB was completed for dates going back to the last participant encounter.
Time Frame	Weeks 0-24

Outcome Measure Data

Analysis Population Description

per protocol

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	204	270
Median (Inter-Quartile Range) [days]	123	87

6. Secondary Outcome

Title	Alcohol Use Over Time, Drinks Per Day, Past 30 Days, W0
Description	Alcohol use over time, drinks per day, past 30 days, at week 0
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [drinks per day]	.8 (2.41)	1.2 (3.75)

7. Secondary Outcome

Title	Cigarette Smoking, W0, 10 or Less
Description	Participants average cigarettes/day, in past 4 weeks, at week 0, equals 10 or less.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Count of Participants [Participants]	112 39.6%	109 38%

8. Secondary Outcome

Title	Opioid Craving Over Time W0
Description	Opioid craving over time via VAS at week 0
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	68.7 (30.55)	68.8 (30.05)

9. Secondary Outcome

Title	Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale
Description	The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	8.6 (6.45)	9.3 (6.63)

10. Secondary Outcome

Title	Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale
Description	The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	.1 (.2)	.1 (.23)

11. Secondary Outcome

Title	Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
Description	The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	5.5 (8.85)	5.9 (10.46)

12. Secondary Outcome

Title	Score on Trail Making Test Part A
Description	Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [seconds]	26.8 (11.09)	25.8 (10.07)

13. Secondary Outcome

Title	Opioid Abstinence Over Time While on Study Medication (Objective)
Description	A urine sample was obtained and tested for opioids at each in person visit; screening, prior to induction onto study medication, weekly through week 24 and at each of the follow up visits.
Time Frame	Weeks 0-24

Outcome Measure Data

Analysis Population Description

Per protocol

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	204	270
Median (Inter-Quartile Range) [Weeks]	13	11

14. Secondary Outcome

Title	Cigarette Smoking, W0 0
Description	Participants average cigarettes/day, in past 4 weeks, at week 0, equals none
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Count of Participants [Participants]	17 6%	18 6.3%

15. Secondary Outcome

Title	Cigarette Smoking, W0 11-20
Description	Participants average cigarettes/day, in past 4 weeks, at week 0, equals 11-20.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Count of Participants [Participants]	106 37.5%	112 39%

16. Secondary Outcome

Title	Cigarette Smoking, W0 21-30
Description	Participants average cigarettes/day, in past 4 weeks, at week 0, equals 21-30
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Count of Participants [Participants]	18 6.4%	21 7.3%

17. Secondary Outcome

Title	Cigarette Smoking, W0 31 or More
Description	Participants average cigarettes/day, in past 4 weeks, at week 0, equals 31 or more
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Count of Participants [Participants]	3 1.1%	8 2.8%

18. Secondary Outcome

Title	Cigarette Smoking, W24 0
Description	Participants average cigarettes/day, in past 4 weeks, at week 24, equals none
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Count of Participants [Participants]	32 11.3%	29 10.1%

19. Secondary Outcome

Title	Cigarette Smoking
Description	Participants average cigarettes/day, in past 4 weeks, at week 24, equals 10 or less.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Count of Participants [Participants]	70 24.7%	78 27.2%

20. Secondary Outcome

Title	Cigarette Smoking, W24 11-20
Description	Participants average cigarettes/day, in past 4 weeks, at week 24, equals 11-20.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Count of Participants [Participants]	57 20.1%	71 24.7%

21. Secondary Outcome

Title	Cigarette Smoking, W24 21-30
Description	Participants average cigarettes/day, in past 4 weeks, at week 24, equals 21-30
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Count of Participants [Participants]	2 0.7%	11 3.8%

22. Secondary Outcome

Title	Cigarette Smoking, W24 31 or More
Description	Participants average cigarettes/day, in past 4 weeks, at week 24, equals 31 or more
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Count of Participants [Participants]	1 0.4%	5 1.7%

23. Secondary Outcome

Title	Score on Opioid Craving Scale (OCS)
Description	OCS is a brief 3-item measure used to measure opioid craving. The scale consists of 3 items rated on a visual analogue scale (VAS) from 1-10. The total range of score is 0-30, and a higher score indicates a stronger craver / desire to use opiates.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	9.9 (21.54)	9.4 (17.67)

24. Secondary Outcome

Title	Score of Subacute Withdrawal Symptoms Subscale Within Hamilton Depression (HAM-D) Rating Scale
Description	The Subacute Withdrawal Symptoms Subscale consists of 6 symptoms. Classification of symptoms can be scored as: 0 - absent, 1 - doubtful or trivial, 2 - present. The total range of scores is 0 - 12, and the higher the total score the more severe the depression.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	5.2 (6.53)	4.8 (5.48)

25. Secondary Outcome

Title	Score on Subjective Opiate Withdrawal Scale (SOWS)
Description	The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The total range of scores is 0-64; the higher the score, the more intense the withdrawal.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	15.6 (13.38)	15.6 (13.15)

26. Secondary Outcome

Title	Score on Subjective Opiate Withdrawal Scale (SOWS)
Description	The SOWS is a self-administered scale for grading opioid withdrawal symptoms. It contains 16 symptoms whose intensity the patient rates on a scale of 0 (not at all) to 4 (extremely). The total range of scores is 0-64; the higher the score, the more intense the withdrawal.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	4.5 (7.53)	5.3 (7.49)

27. Secondary Outcome

Title	Score of Sexual Behavior Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
Description	The Sexual Behavior Subscale consists of 5 questions. Each question is scored from 0-5, for a total score range of 0-25. Higher scores indicate a greater degree of risk-taking behavior.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	7.3 (9.37)	6.0 (10.63)

28. Secondary Outcome

Title	Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
Description	The Sexual Behavior Subscale consists of 3 questions. Each question is scored from 0-5, for a total score range of 0-15. Higher scores indicate a greater degree of risk-taking behavior.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	3.6 (7.34)	4.3 (10.07)

29. Secondary Outcome

Title	Score of Condom Use Subscale Within HIV Risk-Taking Behavior Scale (HRBS)
Description	The Sexual Behavior Subscale consists of 3 questions. Each question is scored from 0-5, for a total score range of 0-15. Higher scores indicate a greater degree of risk-taking behavior.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	4.8 (8.4)	4.3 (10.34)

30. Secondary Outcome

Title	Score on Trail Making Test Part A
Description	Trail Making Test Part A consists of 25 circles distributed over a sheet of paper. The circles are number 1-25, and the patient is asked to draw lines to connect the numbers in ascending order. The patient is instructed to connect the circles as quickly as possible, without lifting the pen or pencil from the paper. Higher scores reveal greater impairment.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [seconds]	21.6 (9.81)	20.3 (7.03)

31. Secondary Outcome

Title	Score on Trail Making Test Part B
Description	Part B consists of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern, by alternating between the numbers and letters. Results are reported as the number of seconds required to complete the task.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [seconds]	79.1 (40.19)	78.3 (40.73)

32. Secondary Outcome

Title	Score on Trail Making Test Part B
Description	Part B consists of 25 circles distributed over a sheet of paper. In Part B, the circles include both numbers (1-13) and letters (A-L); the patient draws lines to connect the circles in an ascending pattern, by alternating between the numbers and letters. Results are reported as the number of seconds required to complete the task.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [seconds]	61.2 (39.32)	58.1 (33.37)

33. Secondary Outcome

Title	Score on Word Card of Stoop Test
Description	The "word card" of the Stoop Test has the names of colors printed in black and white (100 items to be named). The patient's basic score is the total time he/she takes to utter the 100 words on the card.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [seconds]	95.8 (16.6)	96.4 (16.03)

34. Secondary Outcome

Title	Score on Word Card of Stoop Test
Description	The "word card" of the Stoop Test has the names of colors printed in black and white (100 items to be named). The patient's basic score is the total time he/she takes to utter the 100 words on the card.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [seconds]	103.2 (18.02)	102.9 (19.7)

35. Secondary Outcome

Title	Score on Color Card of Stoop Test
Description	The "color card" contains 100 patches of between 3-5 different colors. The patient's task is to utter the names of the colored patches as rapidly as possible, scanning the rows from left to right. The score is the total time (in seconds) it takes to utter the 100 colors.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [seconds]	69.3 (13.63)	70.5 (12.46)

36. Secondary Outcome

Title	Score on Color Card of Stoop Test
Description	The "color card" contains 100 patches of between 3-5 different colors. The patient's task is to utter the names of the colored patches as rapidly as possible, scanning the rows from left to right. The score is the total time (in seconds) it takes to utter the 100 colors.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [seconds]	75.3 (15.31)	76.1 (14.84)

37. Secondary Outcome

Title	Score on Color Word Card of Stoop Test
Description	The "color-word card" contains the printed names of colors, but printed in an ink of a conflicting color (e.g. the word RED might be printed in green, yellow, or blue). The patient is required to name the colors of the inks while ignoring the conflicting printed color names. The basic score is the total time (in seconds) to utter the 100 colors.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [seconds]	41.1 (10.33)	42.2 (9.85)

38. Secondary Outcome

Title	Score on Color Word Card of Stoop Test
Description	The "color-word card" contains the printed names of colors, but printed in an ink of a conflicting color (e.g. the word RED might be printed in green, yellow, or blue). The patient is required to name the colors of the inks while ignoring the conflicting printed color names. The basic score is the total time (in seconds) to utter the 100 colors.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [seconds]	47.6 (12.07)	48.8 (12.35)

39. Secondary Outcome

Title	Score of Alcohol Subscale Within Addiction Severity Index (ASI) Scale
Description	The Alcohol Subscale within ASI is one question that asks how bothered one has been by alcohol problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	.1 (.11)	0.0 (0.11)

40. Secondary Outcome

Title	Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale
Description	The Drug Use Subscale within ASI is one question that asks how bothered one has been by drug use problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	0.3 (0.08)	.3 (0.09)

41. Secondary Outcome

Title	Score of Drug Use Subscale Within Addiction Severity Index (ASI) Scale
Description	The Drug Use Subscale within ASI is one question that asks how bothered one has been by drug use problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	.1 (.13)	.1 (.12)

42. Secondary Outcome

Title	Score of Social Relationship Subscale Within Addiction Severity Index (ASI) Scale
Description	The Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	.3 (.25)	.3 (.24)

43. Secondary Outcome

Title	Score of Family / Social Relationship Subscale Within Addiction Severity Index (ASI) Scale
Description	The Family / Social Relationship Subscale within ASI contains 2 questions that ask how bothered one has been by family or social problems. The total range of the subscale is 0-8. The higher the score, the bigger the problem.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	.1 (.18)	.1 (.19)

44. Secondary Outcome

Title	Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale
Description	The Legal Status Subscale within ASI is one question that asks how bothered one has been by legal problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	.2 (.21)	.2 (.21)

45. Secondary Outcome

Title	Score of Legal Status Subscale Within Addiction Severity Index (ASI) Scale
Description	The Legal Status Subscale within ASI is one question that asks how bothered one has been by legal problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	.1 (.17)	.1 (.17)

46. Secondary Outcome

Title	Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale
Description	The Medical Status Subscale within ASI is one question that asks how bothered one has been by medical problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	.2 (.25)	.2 (.27)

47. Secondary Outcome

Title	Score of Medical Status Subscale Within Addiction Severity Index (ASI) Scale
Description	The Medical Status Subscale within ASI is one question that asks how bothered one has been by medical problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	.1 (.24)	.2 (.25)

48. Secondary Outcome

Title	Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale
Description	The Psychiatric Status Subscale within ASI is one question that asks how bothered one has been by psychiatric or emotional problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	.3 (.22)	.3 (.22)

49. Secondary Outcome

Title	Score of Psychiatric Status Subscale Within Addiction Severity Index (ASI) Scale
Description	The Psychiatric Status Subscale within ASI is one question that asks how bothered one has been by psychiatric or emotional problems. The total range of the subscale is 0-4. The higher the score, the bigger the problem.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	.2 (.21)	.2 (.21)

50. Secondary Outcome

Title	Score on EuroQOL EQ-5D Questionnaire
Description	Problems related to drug abuse is assessed through this questionnaire, which consists of 5 conditions. Each condition is scored from 0-2 for a total score range of 0-10. The higher the score, the more problems.
Time Frame	Week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	6.8 (1.44)	6.8 (1.31)

51. Secondary Outcome

Title	Score on EuroQOL EQ-5D Questionnaire
Description	Problems related to drug abuse is assessed through this questionnaire, which consists of 5 conditions. Each condition is scored from 0-2 for a total score range of 0-10. The higher the score, the more problems.
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [score on a scale]	5.8 (1.15)	6.1 (1.28)

52. Secondary Outcome

Title	Alcohol Use Over Time, Drinks Per Day
Description	Alcohol use over time, drinks per day
Time Frame	Week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Mean (Standard Deviation) [drinks per day]	.1 (.82)	.4 (1.57)

53. Secondary Outcome

Title	Other Drug Use Over Time, Cannabis, W0
Description	Other drug use over time measuring cannabis at week 0
Time Frame	week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Count of Participants [Participants]	123 43.5%	135 47%

54. Secondary Outcome

Title	Other Drug Use Over Time, Cannabis, W24
Description	Other drug use over time measuring cannabis at week 24
Time Frame	week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Count of Participants [Participants]	20 7.1%	20 7%

55. Secondary Outcome

Title	Other Drug Use Over Time, Cocaine, W0
Description	Other drug use over time measuring cocaine at week 0
Time Frame	week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Count of Participants [Participants]	61 21.6%	80 27.9%

56. Secondary Outcome

Title	Other Drug Use Over Time, Cocaine, W24
Description	Other drug use over time measuring cocaine at week 0
Time Frame	week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Count of Participants [Participants]	5 1.8%	2 0.7%

57. Secondary Outcome

Title	Other Drug Use Over Time, Stimulant, W0
Description	Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 0
Time Frame	week 0

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Count of Participants [Participants]	132 46.6%	166 57.8%

58. Secondary Outcome

Title	Other Drug Use Over Time, Stimulant, W24
Description	Other drug use over time measuring stimulant (cocaine, crack and amphetamine) at week 24
Time Frame	week 24

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended-Release Naltrexone	Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)	Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
Measure Participants	283	287
Count of Participants [Participants]	5 1.8%	3 1%

Adverse Events

Time Frame	Weeks 0-36
Adverse Event Reporting Description	Treatment emergent adverse events are those that occurred after study day of induction for those participants were inducted onto study medication.
Arm/Group Title	Extended-Release Naltrexone		Buprenorphine-Naloxone
Arm/Group Description	Extended-Release Naltrexone (Vivitrol) Extended-Release Naltrexone: Extended-Release Naltrexone (Vivitrol®)		Buprenorphine-Naloxone (Suboxone) Buprenorphine-Naloxone: Buprenorphine-Naloxone (Suboxone®)
All Cause Mortality
	Extended-Release Naltrexone		Buprenorphine-Naloxone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	3/283 (1.1%)		4/287 (1.4%)
Serious Adverse Events
	Extended-Release Naltrexone		Buprenorphine-Naloxone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	41/283 (14.5%)		31/287 (10.8%)
Eye disorders
Eye disorders	1/283 (0.4%)		0/270 (0%)
Gastrointestinal disorders
Gastrointestinal disorders	1/283 (0.4%)		2/270 (0.7%)
General disorders
General disorders and administration site conditions	2/283 (0.7%)		2/270 (0.7%)
Hepatobiliary disorders
Hepatobiliary disorders	0/283 (0%)		1/270 (0.4%)
Infections and infestations
Infections and infestations	7/283 (2.5%)		6/287 (2.1%)
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications	17/283 (6%)		8/270 (3%)
Metabolism and nutrition disorders
Metabolism and nutrition disorders	1/283 (0.4%)		0/270 (0%)
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders	0/283 (0%)		1/270 (0.4%)
Nervous system disorders
Nervous system disorders	2/283 (0.7%)		2/270 (0.7%)
Pregnancy, puerperium and perinatal conditions
Pregnancy	0/283 (0%)		1/270 (0.4%)
Psychiatric disorders
Psychiatric	10/283 (3.5%)		12/287 (4.2%)
Reproductive system and breast disorders
Reproductive system and breast disorders	1/283 (0.4%)		0/270 (0%)
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic, and mediastinal disorders	5/283 (1.8%)		0/270 (0%)
Other (Not Including Serious) Adverse Events
	Extended-Release Naltrexone		Buprenorphine-Naloxone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	118/283 (41.7%)		135/287 (47%)
Blood and lymphatic system disorders
Blood and lymphatic system disorders	1/283 (0.4%)		0/287 (0%)
Cardiac disorders
Cardiac disorders	1/283 (0.4%)		0/287 (0%)
Ear and labyrinth disorders
Ear and labyrinth disorders	1/283 (0.4%)		1/287 (0.3%)
Eye disorders
Eye disorders	6/283 (2.1%)		3/287 (1%)
Gastrointestinal disorders
Gastrointestinal	36/283 (12.7%)		58/287 (20.2%)
General disorders
General Disorders and Administration Site Conditions	10/283 (3.5%)		21/287 (7.3%)
Hepatobiliary disorders
Hepatbiliary disorders	1/283 (0.4%)		1/287 (0.3%)
Immune system disorders
Immune system disorders	0/283 (0%)		1/287 (0.3%)
Infections and infestations
Infections and infestations	22/283 (7.8%)		22/287 (7.7%)
Injury, poisoning and procedural complications
Injury poisoning and procedural complications	18/283 (6.4%)		22/287 (7.7%)
Investigations
Investigations	10/283 (3.5%)		11/287 (3.8%)
Metabolism and nutrition disorders
Metabolism and nutrition	6/283 (2.1%)		4/287 (1.4%)
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders	16/283 (5.7%)		15/287 (5.2%)
Nervous system disorders
Nervous system disorders	29/283 (10.2%)		27/287 (9.4%)
Product Issues
Product issues	0/283 (0%)		1/287 (0.3%)
Psychiatric disorders
Psychiatric	29/283 (10.2%)		22/287 (7.7%)
Renal and urinary disorders
Renal and urinary disorders	4/283 (1.4%)		5/287 (1.7%)
Reproductive system and breast disorders
Reproductive system and breast disorders	2/283 (0.7%)		3/287 (1%)
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders	7/283 (2.5%)		7/287 (2.4%)
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders	9/283 (3.2%)		7/287 (2.4%)
Social circumstances
Social circumstances	1/283 (0.4%)		0/287 (0%)
Surgical and medical procedures
Surgical and medical procedures	0/283 (0%)		3/287 (1%)
Vascular disorders
Vascular disorders	1/283 (0.4%)		6/287 (2.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.