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Completed

NCT Number: NCT02730403

TAU Opioid Use Outcomes Following Discharge From Detoxification and Short Term Residential Programs Affiliated With 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.

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Tarzana Treatment Centers, Tarzana, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment as Usual

Other

Primary outcomes

  1. Days of Opioid Use

    Time frame: Up to Week 4 Post Discharge

    Days of use during the first 4 weeks post discharge

  2. Positive Urine Drug Screen (UDS) at Week 1

    Time frame: week 1

    Number of positive UDSs at Week 1

  3. Negative UDSs at Week 1

    Time frame: week 1

    Number of negative UDSs at Week 1

  4. Missing UDSs at Week 1

    Time frame: week 1

    Number of missing UDSs at Week 1

  5. Missing UDSs at Week 4

    Time frame: week 4

    Number of missing UDSs at Week 4

  6. Positive UDSs at Week 4

    Time frame: week 4

    Number of positive UDSs at Week 4

  7. Negative UDSs at Week 4

    Time frame: week 4

    Number of negative UDSs at Week 4

  8. Missing UDSs at Week 8

    Time frame: week 8

    Number of missing UDSs at Week 8

  9. Negative UDSs at Week 8

    Time frame: week 8

    Number of negative UDSs at Week 8

  10. Positive UDSs at Week 8

    Time frame: week 8

    Number of positive UDSs at Week 8

  11. Time to First Use

    Time frame: Up to Week 8 Post Discharge

    Days to first opioid use from Timeline Followback

  12. Time to Regular Use

    Time frame: Up to Week 8 Post Discharge

    Days to regular opioid use from Timeline Followback

  13. Days of Opioid Use

    Time frame: Up to Week 8 Post Discharge

    Days of use up 8 weeks post discharge

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 6, 2016
Registry last updated
Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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