TAU Opioid Use Outcomes Following Discharge From Detoxification and Short Term Residential Programs Affiliated With CTN-0051

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT02730403
• Collaborator: (none)
• Enrollment: 211
• Locations: 5
• Actual Duration (Months): 8
• Patients Per Site: 42.2
• Patients Per Site Per Month: 5.3

Study Details

Study Description

Brief Summary

This is an observational, "ancillary study" intended to describe opioid use among opioid use disorder patients following their discharge into the community from inpatient detoxification and/or short-term residential treatment programs affiliated with parent study CTN-0051, which assessed 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.

Condition or Disease	Intervention/Treatment	Phase
Opioid Use Disorder	Other: Treatment As Usual

Detailed Description

Participant recruitment will begin after recruitment for CTN-0051 has been completed. Opioid use disorder patients will be recruited prior to leaving detoxification and/or short-term residential programs. Screening and baseline data (focused on demographics, diagnosis and service utilization) will be collected prior to discharge, and follow-up data (focused on opioid use) will be collected at weeks 1, 4 and 8 following discharge.

Study Design

• Study Type: Observational
• Actual Enrollment: 211 participants
• Observational Model: Other
• Time Perspective: Prospective
• Official Title: Treatment-as-Usual (TAU) Opioid Use Outcomes Following Discharge From Detoxification and Short Term Residential Programs Affiliated With National Institute on Drug Abuse (NIDA) CTN-0051
• Actual Study Start Date: Jun 1, 2016
• Actual Primary Completion Date: Jan 30, 2017
• Actual Study Completion Date: Jan 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Opioid Use Disorder Patients	Other: Treatment As Usual

Outcome Measures

Primary Outcome Measures

1. Days of Opioid Use [Up to Week 4 Post Discharge]

   Days of use during the first 4 weeks post discharge

2. Positive Urine Drug Screen (UDS) at Week 1 [week 1]

   Number of positive UDSs at Week 1

3. Negative UDSs at Week 1 [week 1]

   Number of negative UDSs at Week 1

4. Missing UDSs at Week 1 [week 1]

   Number of missing UDSs at Week 1

5. Missing UDSs at Week 4 [week 4]

   Number of missing UDSs at Week 4

6. Positive UDSs at Week 4 [week 4]

   Number of positive UDSs at Week 4

7. Negative UDSs at Week 4 [week 4]

   Number of negative UDSs at Week 4

8. Missing UDSs at Week 8 [week 8]

   Number of missing UDSs at Week 8

9. Negative UDSs at Week 8 [week 8]

   Number of negative UDSs at Week 8

10. Positive UDSs at Week 8 [week 8]

    Number of positive UDSs at Week 8

11. Time to First Use [Up to Week 8 Post Discharge]

    Days to first opioid use from Timeline Followback

12. Time to Regular Use [Up to Week 8 Post Discharge]

    Days to regular opioid use from Timeline Followback

13. Days of Opioid Use [Up to Week 8 Post Discharge]

    Days of use up 8 weeks post discharge

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• 18 years or older;

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

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

• Seeking treatment for opioid dependence;

• Able to provide written informed consent;

• Able to speak English sufficiently to understand the study procedures.

Exclusion Criteria:

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

• Suicidal or homicidal ideation that requires immediate attention;

• 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;

• Prior participation in parent trial CTN-0051

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	Stanley Street Treatment and Resources	Fall River	Massachusetts	United States	02720
4	Bellevue Hospital	New York	New York	United States	10016
5	Maryhaven	Columbus	Ohio	United States	43207

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: John Rotrosen, MD, New York University Medical School

Study Documents (Full-Text)

• Study Protocol - Aug 5, 2016
• Statistical Analysis Plan - Apr 26, 2017

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02730403
• Other Study ID Numbers: 16-00090
• First Posted: Apr 6, 2016
• Last Update Posted: Mar 27, 2020
• Last Verified: Mar 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Opioid-Related Disorders

Study Results

Participant Flow

Arm/Group Title	Treatment As Usual
Arm/Group Description	Patients admitted to detoxification or short term residential programs associated with CTN-0051 for Opioid Use Disorder (OUD).
Period Title: Overall Study
STARTED	211
COMPLETED	157
NOT COMPLETED	54

Baseline Characteristics

Arm/Group Title	Treatment As Usual
Arm/Group Description	Patients admitted to detoxification or short term residential programs associated with CTN-0051 with OUD.
Overall Participants	211
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	211 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35 (9.48)
Age, Customized (Count of Participants)
18 - <25	23 10.9%
25 - <35	96 45.5%
35 - <45	52 24.6%
45 - <55	33 15.6%
55 - <65	7 3.3%
Sex: Female, Male (Count of Participants)
Female	55 26.1%
Male	156 73.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	37 17.5%
Not Hispanic or Latino	172 81.5%
Unknown or Not Reported	2 0.9%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	4 1.9%
Asian	1 0.5%
Native Hawaiian or Other Pacific Islander	1 0.5%
Black or African American	28 13.3%
White	143 67.8%
More than one race	10 4.7%
Unknown or Not Reported	24 11.4%
Region of Enrollment (participants) [Number]
United States	211 100%
Baseline Opioid Severity (Count of Participants)
Low	110 52.1%
High	101 47.9%

Outcome Measures

1. Primary Outcome

Title	Days of Opioid Use
Description	Days of use during the first 4 weeks post discharge
Time Frame	Up to Week 4 Post Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment As Usual
Arm/Group Description	Patients admitted to detoxification or short term residential associated with CTN-0051 for OUD.
Measure Participants	211
Mean (Standard Deviation) [days]	6.8 (8.95)

2. Primary Outcome

Title	Positive Urine Drug Screen (UDS) at Week 1
Description	Number of positive UDSs at Week 1
Time Frame	week 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment As Usual
Arm/Group Description	Patients admitted to detoxification or short term residential treatment programs associated with CTN-0051 with OUD.
Measure Participants	211
Count of Participants [Participants]	106 50.2%

3. Primary Outcome

Title	Negative UDSs at Week 1
Description	Number of negative UDSs at Week 1
Time Frame	week 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment As Usual
Arm/Group Description	Patients admitted to detoxification or short term residential treatment programs associated with CTN-0051 with OUD.
Measure Participants	211
Count of Participants [Participants]	60 28.4%

4. Primary Outcome

Title	Missing UDSs at Week 1
Description	Number of missing UDSs at Week 1
Time Frame	week 1

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment As Usual
Arm/Group Description	Patients admitted to detoxification or short term residential treatment programs associated with CTN-0051 with OUD.
Measure Participants	211
Count of Participants [Participants]	45 21.3%

5. Primary Outcome

Title	Missing UDSs at Week 4
Description	Number of missing UDSs at Week 4
Time Frame	week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment As Usual
Arm/Group Description	Patients admitted to detoxification or short term residential treatment programs associated with CTN-0051 with OUD.
Measure Participants	211
Count of Participants [Participants]	54 25.6%

6. Primary Outcome

Title	Positive UDSs at Week 4
Description	Number of positive UDSs at Week 4
Time Frame	week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment As Usual
Arm/Group Description	Patients admitted to detoxification or short term residential treatment programs associated with CTN-0051 with OUD.
Measure Participants	211
Count of Participants [Participants]	102 48.3%

7. Primary Outcome

Title	Negative UDSs at Week 4
Description	Number of negative UDSs at Week 4
Time Frame	week 4

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment As Usual
Arm/Group Description	Patients admitted to detoxification or short term residential treatment programs associated with CTN-0051 with OUD.
Measure Participants	211
Count of Participants [Participants]	55 26.1%

8. Primary Outcome

Title	Missing UDSs at Week 8
Description	Number of missing UDSs at Week 8
Time Frame	week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment As Usual
Arm/Group Description	Patients admitted to detoxification or short term residential treatment programs associated with CTN-0051 with OUD.
Measure Participants	211
Count of Participants [Participants]	55 26.1%

9. Primary Outcome

Title	Negative UDSs at Week 8
Description	Number of negative UDSs at Week 8
Time Frame	week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment As Usual
Arm/Group Description	Patients admitted to detoxification or short term residential treatment programs associated with CTN-0051 with OUD.
Measure Participants	211
Count of Participants [Participants]	66 31.3%

10. Primary Outcome

Title	Positive UDSs at Week 8
Description	Number of positive UDSs at Week 8
Time Frame	week 8

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment As Usual
Arm/Group Description	Patients admitted to detoxification or short term residential treatment programs associated with CTN-0051 with OUD.
Measure Participants	211
Count of Participants [Participants]	90 42.7%

11. Primary Outcome

Title	Time to First Use
Description	Days to first opioid use from Timeline Followback
Time Frame	Up to Week 8 Post Discharge

Outcome Measure Data

Analysis Population Description

Patients admitted to detoxification or short term residential programs associated with CTN-0051 for OUD

Arm/Group Title	Treatment As Usual
Arm/Group Description	Patients admitted to detoxification or short term residential associated with CTN-0051 for OUD.
Measure Participants	211
Mean (Standard Deviation) [days]	7.5 (10.17)

12. Primary Outcome

Title	Time to Regular Use
Description	Days to regular opioid use from Timeline Followback
Time Frame	Up to Week 8 Post Discharge

Outcome Measure Data

Analysis Population Description

Patients admitted to detoxification or short term residential programs associated with CTN-0051 for OUD

Arm/Group Title	Treatment As Usual
Arm/Group Description	Patients admitted to detoxification or short term residential associated with CTN-0051 for OUD.
Measure Participants	211
Mean (Standard Deviation) [days]	11.3 (11.58)

13. Primary Outcome

Title	Days of Opioid Use
Description	Days of use up 8 weeks post discharge
Time Frame	Up to Week 8 Post Discharge

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment As Usual
Arm/Group Description	Patients admitted to detoxification or short term residential associated with CTN-0051 for OUD.
Measure Participants	211
Mean (Standard Deviation) [days]	13.2 (16.7)

Adverse Events

Time Frame	9 month
Adverse Event Reporting Description	For purposes of this study, only overdoses (whether hospitalized or not) and all deaths were collected. The relationship of adverse event was only collected for overdose events.
Arm/Group Title	Treatment As Usual
Arm/Group Description	Patients who were admitted to detoxification or short term residential programs associated with CTN-0051 with OUD.
All Cause Mortality
	Treatment As Usual
	Affected / at Risk (%)	# Events
Total	1/211 (0.5%)
Serious Adverse Events
	Treatment As Usual
	Affected / at Risk (%)	# Events
Total	7/211 (3.3%)
Respiratory, thoracic and mediastinal disorders
Overdose	7/211 (3.3%)	7
Other (Not Including Serious) Adverse Events
	Treatment As Usual
	Affected / at Risk (%)	# Events
Total	8/211 (3.8%)
Respiratory, thoracic and mediastinal disorders
Overdose	8/211 (3.8%)	12

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.