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

Completed

Conditions studied: Opioid Use Disorder

In brief

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.

Key facts

Study ID

NCT02730403

Run by

NYU Langone Health

People needed

211

Starts

2016-06-01

Expected to finish

2017-01-30

Last updated by the study team

2020-03-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Tarzana Treatment Centers — Tarzana, California, United States
• Gateway Community Services, Inc. — Jacksonville, Florida, United States
• Stanley Street Treatment and Resources — Fall River, Massachusetts, United States
• Bellevue Hospital — New York, New York, United States
• Maryhaven — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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