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

Opioid Use Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02730403
• Other study ID #: 16-00090
• Status: Completed
• Start date: June 1, 2016
• Est. completion date: January 30, 2017

Study information

• Verified date: March 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 211
• Est. completion date: January 30, 2017
• Est. primary completion date: January 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use Disorder

Intervention

Other:
• Treatment As Usual

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

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