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

NCT02730403 | Completed Results DMC

• 1 other identifier: 16-00090
• Study Type: observational
• Target: 211
• Locations: 1 country
• Sites: 5

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.

Conditions

Opioid Use Disorder

Outcome Measures

Primary Outcomes (13)

• 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

Study Arms (1)

Opioid Use Disorder Patients

Other: Treatment As Usual

Interventions

Treatment As Usual OTHER

Opioid Use Disorder Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be a convenience sample of up to three hundred sixty (360) opioid dependent patients leaving detoxification or short-term residential units at sites participating in CTN-0051. Up to 60 participants will be recruited at each of approximately six sites.

You may qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (5)

Tarzana Treatment Centers

Tarzana, California, 91356, United States

Location

Gateway Community Services, Inc.

Jacksonville, Florida, 32201, United States

Location

Stanley Street Treatment and Resources

Fall River, Massachusetts, 02720, United States

Location

Bellevue Hospital

New York, New York, 10016, United States

Location

Maryhaven

Columbus, Ohio, 43207, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Results Point of Contact

• Title: John Rotrosen
• Organization: NYU Grossman School of Medicine

john.rotrosen@nyulangone.org

646-754-4763

Study Officials

• John Rotrosen, MD

  New York University Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 21, 2016
• First Posted: April 6, 2016
• Study Start: June 1, 2016
• Primary Completion: January 30, 2017
• Study Completion: January 30, 2017
• Last Updated: March 27, 2020
• Results First Posted: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share

Locations

US (5)