Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence

• Sponsor: Yale University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00555425
• Collaborator: National Institute on Drug Abuse (NIDA) (NIH)
• Enrollment: 113
• Locations: 2
• Arms: 2
• Duration (Months): 58
• Patients Per Site: 56.5
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The aim of the study is to determine whether buprenorphine/naloxone maintenance versus detoxification using buprenorphine/naloxone, in prescription opioid dependent patients receiving primary care management and drug counseling in an office-based setting, leads to decreased illicit opioid use.

Condition or Disease	Intervention/Treatment	Phase
Opiate Dependence	Behavioral: Behavioral: Buprenorphine/naloxone maintenance (Mtn); Behavioral: Behavioral: Buprenorphine/naloxone detoxification (Dtx)	Phase 4

Detailed Description

Prescription opioid dependence is increasing and creates a significant public health burden, but office-based physicians lack evidence-based guidelines to decide between maintenance or detoxification treatment with buprenorphine/naloxone. The proposed study compares buprenorphine/naloxone maintenance (Mtn) vs. detoxification (Dtx) in a 18-week randomized clinical trail in a heterogeneous population of prescription opioid dependent patients (N=120) in a primary care clinic. Patients are randomized to Mtn or Dtx after a 2-week induction period. Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, buprenorphine/naloxone will continue unchanged for the remainder of the study. In Dtx, the dosage of buprenorphine/naloxone will be tapered to zero over the next 3 weeks, and patients will not receive additional buprenorphine/naloxone for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup. The study will test the hypothesis that Mtn will lead to decreased illicit drug use and will demonstrate incremental cost-effectiveness compared to Dtx. Relevance to public health: The results of this study will help define the role of maintenance vs. detoxification with buprenorphine/naloxone in the care of prescription opioid dependent patients in primary care.

Study Design

• Study Type: Interventional
• Actual Enrollment: 113 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Buprenorphine Maintenance vs. Detoxification in Prescription Opioid Dependence
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.	Behavioral: Behavioral: Buprenorphine/naloxone maintenance (Mtn); Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.
Experimental: 2 Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.	Behavioral: Behavioral: Buprenorphine/naloxone detoxification (Dtx); Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.

Outcome Measures

Primary Outcome Measures

1. Illicit Opioid Use [18 weeks]

   Urinalysis based on scheduled weekly urine screenings during treatment period

Secondary Outcome Measures

1. Proportion of Patients Protectively Transferred [18 weeks]

   >= 2 consecutive weeks of daily illicit opioid use and opioid positive urine samples after completion of the first 6 weeks of the study

2. Retention in Treatment [18 weeks]

   Mean number of days from randomization to last clinical contact

3. Reduction in Cocaine Use [18 weeks]

   As measured by the percent of provided urines positive for cocaine

4. Changes in HIV Risk [Baseline and 18 weeks]

   As measured by the AIDS Risk Inventory. The AIDS Risk Inventory (ARI) is a 166 item structured interview that assesses the number and frequency of drug-related and sexual risk behaviors in the preceding 3 months. Calculation of the ARI total score is based on the frequency of occurrence of a given behavior and on the recency of this behavior, with recency being weighted more than a life-time occurrence of the same behavior. Higher values are associated with greater risk of HIV transmission (worse). There are 10 subscales comprised of between 8 and 24 items. Subscales scores are based on the sum of the individual items and the overall ARI total score is the sum of the subscales. Scores can range from 0 to 350, although among opioid dependent patients most values are below 100 with means between 50 and 60 depending on characteristics of the patients and treatment status.

5. Patient Satisfaction [18 weeks]

   Patient satisfaction as measured by survey. Primary Care Buprenorphine Satisfaction Scale (PCBSS). Comprises of 19 items evaluating satisfaction with staff expertise, concern, and responsiveness. Range of scores from 15-95. I higher score indicates greater satisfaction.

6. Health Status [18 weeks]

   Measured by the SF-36 overall transformed measure. In the SF-36 all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• opioid dependence

Exclusion Criteria:

• current dependence on alcohol, cocaine, benzodiazepines or sedatives

• current suicide or homicide risk

• current psychotic disorder or untreated major depression

• inability to read or understand English

• life-threatening or unstable medical problems

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The APT Foundation, Inc. -- Welch Building	New Haven	Connecticut	United States	06519
2	Yale University School of Medicine	New Haven	Connecticut	United States	06520

Sponsors and Collaborators

• Yale University
• National Institute on Drug Abuse (NIDA)

Investigators

• Principal Investigator: David A. Fiellin, MD, Yale University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT00555425
• Other Study ID Numbers: 0504027597; 1R01DA020576-01A1; R01DA020576; DPMC; NCT00595400
• First Posted: Nov 8, 2007
• Last Update Posted: Jan 14, 2019
• Last Verified: Jan 1, 2019

• Keywords provided by Yale University: Buprenorphine; Buprenorphine/naloxone; Counseling; Primary care
• Additional relevant MeSH terms: Opioid-Related Disorders; Buprenorphine; Buprenorphine, Naloxone Drug Combination; Naloxone

Study Results

Participant Flow

Pre-assignment Detail	289 Patients underwent assessment for eligibility, 29 did not meet inclusion criteria, 132 lost contact or chose other treatment, and 15 did not complete induction

Arm/Group Title	Taper Condition	Maintenance Condition
Arm/Group Description	Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone. Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.	Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.
Period Title: Overall Study
STARTED	57	56
COMPLETED	6	37
NOT COMPLETED	51	19

Baseline Characteristics

Arm/Group Title	Taper Condition	Maintenance Condition	Total
Arm/Group Description	Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone. Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.	Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.	Total of all reporting groups
Overall Participants	57	56	113
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.3 (8.8)	30.5 (9.8)	30.4 (9.3)
Sex: Female, Male (Count of Participants)
Female	23 40.4%	25 44.6%	48 42.5%
Male	34 59.6%	31 55.4%	65 57.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	4 7%	4 7.1%	8 7.1%
Not Hispanic or Latino	53 93%	52 92.9%	105 92.9%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 1.8%	0 0%	1 0.9%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	1 1.8%	1 0.9%
White	56 98.2%	52 92.9%	108 95.6%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	3 5.4%	3 2.7%

Outcome Measures

1. Primary Outcome

Title	Illicit Opioid Use
Description	Urinalysis based on scheduled weekly urine screenings during treatment period
Time Frame	18 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Taper Condition	Maintenance Condition
Arm/Group Description	Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone. Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.	Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.
Measure Participants	57	56
Mean (95% Confidence Interval) [percent of opioid negative urine samples]	35.2	53.2

2. Secondary Outcome

Title	Proportion of Patients Protectively Transferred
Description	>= 2 consecutive weeks of daily illicit opioid use and opioid positive urine samples after completion of the first 6 weeks of the study
Time Frame	18 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Taper Condition	Maintenance Condition
Arm/Group Description	Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone. Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.	Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.
Measure Participants	57	56
Number [participants]	16 28.1%	3 5.4%

3. Secondary Outcome

Title	Retention in Treatment
Description	Mean number of days from randomization to last clinical contact
Time Frame	18 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Taper Condition	Maintenance Condition
Arm/Group Description	Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone. Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.	Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.
Measure Participants	57	56
Mean (95% Confidence Interval) [number of days]	57.5	98.7

4. Secondary Outcome

Title	Reduction in Cocaine Use
Description	As measured by the percent of provided urines positive for cocaine
Time Frame	18 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Taper Condition	Maintenance Condition
Arm/Group Description	Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone. Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.	Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.
Measure Participants	57	56
Mean (Standard Deviation) [percent of cocaine positive urines]	11.5 (25.9)	11.1 (23.5)

5. Secondary Outcome

Title	Changes in HIV Risk
Description	As measured by the AIDS Risk Inventory. The AIDS Risk Inventory (ARI) is a 166 item structured interview that assesses the number and frequency of drug-related and sexual risk behaviors in the preceding 3 months. Calculation of the ARI total score is based on the frequency of occurrence of a given behavior and on the recency of this behavior, with recency being weighted more than a life-time occurrence of the same behavior. Higher values are associated with greater risk of HIV transmission (worse). There are 10 subscales comprised of between 8 and 24 items. Subscales scores are based on the sum of the individual items and the overall ARI total score is the sum of the subscales. Scores can range from 0 to 350, although among opioid dependent patients most values are below 100 with means between 50 and 60 depending on characteristics of the patients and treatment status.
Time Frame	Baseline and 18 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Taper Condition	Maintenance Condition
Arm/Group Description	Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone. Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.	Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.
Measure Participants	57	56
Baseline	66.7 (25.6)	67.6 (25.7)
18 weeks	74.5 (19.4)	74.4 (18)

6. Secondary Outcome

Title	Patient Satisfaction
Description	Patient satisfaction as measured by survey. Primary Care Buprenorphine Satisfaction Scale (PCBSS). Comprises of 19 items evaluating satisfaction with staff expertise, concern, and responsiveness. Range of scores from 15-95. I higher score indicates greater satisfaction.
Time Frame	18 weeks

Outcome Measure Data

Analysis Population Description

Results are provided on those individuals who completed this assessment

Arm/Group Title	Taper Condition	Maintenance Condition
Arm/Group Description	Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone. Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.	Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.
Measure Participants	37	45
Mean (95% Confidence Interval) [units on a scale]	78.7	79.9

7. Secondary Outcome

Title	Health Status
Description	Measured by the SF-36 overall transformed measure. In the SF-36 all items are scored so that a high score defines a more favorable health state. In addition, each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively.
Time Frame	18 weeks

Outcome Measure Data

Analysis Population Description

Results are provided on those individuals who completed this assessment

Arm/Group Title	Taper Condition	Maintenance Condition
Arm/Group Description	Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone. Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.	Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.
Measure Participants	47	54
Baseline	67.2 (20.4)	67.6 (18.6)
In-Treatment	68.7 (30.5)	66.6 (21.9)

Adverse Events

Arm/Group Title	Taper Condition		Maintenance Condition
Arm/Group Description	Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone. Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup.		Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study.
All Cause Mortality
	Taper Condition		Maintenance Condition
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Taper Condition		Maintenance Condition
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		0/56 (0%)
Other (Not Including Serious) Adverse Events
	Taper Condition		Maintenance Condition
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/57 (0%)		0/56 (0%)

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.