N/A
N=211
TAU Opioid Use Outcomes Following Discharge From Detoxification and Short Term Residential Programs Affiliated With CTN-0051
Opioid Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02730403 ↗Enrolled (actual)
211
Serious AEs
3.3%
Results posted
Mar 2020
Primary outcome: Primary: Days of Opioid Use — 6.8 days
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Treatment As Usual (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days of Opioid Use |
13.2 | — |
| PRIMARY Positive Urine Drug Screen (UDS) at Week 1 |
106 | — |
| PRIMARY Negative UDSs at Week 1 |
60 | — |
| PRIMARY Missing UDSs at Week 1 |
45 | — |
| PRIMARY Missing UDSs at Week 4 |
54 | — |
| PRIMARY Positive UDSs at Week 4 |
102 | — |
| PRIMARY Negative UDSs at Week 4 |
55 | — |
| PRIMARY Missing UDSs at Week 8 |
55 | — |
| PRIMARY Negative UDSs at Week 8 |
66 | — |
| PRIMARY Positive UDSs at Week 8 |
90 | — |
| PRIMARY Time to First Use |
7.5 | — |
| PRIMARY Time to Regular Use |
11.3 | — |
| PRIMARY Days of Opioid Use |
13.2 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02730403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.