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

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

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Other: Treatment As Usual

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 211

Contacts and Locations

Study Locations

• United States
  • California
    • Tarzana, California, United States, 91356
      • Tarzana Treatment Centers
  • Florida
    • Jacksonville, Florida, United States, 32201
      • Gateway Community Services, Inc.
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • Stanley Street Treatment and Resources
  • New York
    • New York, New York, United States, 10016
      • Bellevue Hospital
  • Ohio
    • Columbus, Ohio, United States, 43207
      • Maryhaven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Opioid Use Disorder Patients	Other: Treatment As Usual

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: John Rotrosen, MD, New York University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): January 30, 2017
• Study Completion (Actual): January 30, 2017

Study Registration Dates

• First Submitted: March 21, 2016
• First Submitted That Met QC Criteria: March 31, 2016
• First Posted (Estimate): April 6, 2016

Study Record Updates

• Last Update Posted (Actual): March 27, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 16-00090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES