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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Opioid Use Disorder

Intervention / Treatment
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* Other: Treatment As Usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Opioid Use Disorder Patients<br> | Other: Treatment As Usual<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of Opioid Use | Days of use during the first 4 weeks post discharge | Up to Week 4 Post Discharge | 
| Positive Urine Drug Screen (UDS) at Week 1 | Number of positive UDSs at Week 1 | week 1 | 
| Negative UDSs at Week 1 | Number of negative UDSs at Week 1 | week 1 | 
| Missing UDSs at Week 1 | Number of missing UDSs at Week 1 | week 1 | 
| Missing UDSs at Week 4 | Number of missing UDSs at Week 4 | week 4 | 
| Positive UDSs at Week 4 | Number of positive UDSs at Week 4 | week 4 | 
| Negative UDSs at Week 4 | Number of negative UDSs at Week 4 | week 4 | 
| Missing UDSs at Week 8 | Number of missing UDSs at Week 8 | week 8 | 
| Negative UDSs at Week 8 | Number of negative UDSs at Week 8 | week 8 | 
| Positive UDSs at Week 8 | Number of positive UDSs at Week 8 | week 8 | 
| Time to First Use | Days to first opioid use from Timeline Followback | Up to Week 8 Post Discharge | 
| Time to Regular Use | Days to regular opioid use from Timeline Followback | Up to Week 8 Post Discharge | 
| Days of Opioid Use | Days of use up 8 weeks post discharge | Up to Week 8 Post Discharge |