Status:

TERMINATED

Response to Relapse in Office-Based Opioid Treatment Trial

Lead Sponsor:

Boston Medical Center

Collaborating Sponsors:

Substance Abuse and Mental Health Services Administration (SAMHSA)

Conditions:

Opioid-use Disorder

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

In a sample of individuals with co-occurring OUD and mental disorders, the investigators plan to test two medications for opioid use disorder (MOUD) treatment protocols that involve differing approach...

Detailed Description

This study is a single-center, two-arm, 6-month (24-week), parallel group, open-label, randomized controlled trial to examine the effectiveness of two approaches to managing relapse to illicit drug us...

Eligibility Criteria

Inclusion

  • Opioid use disorder \[based on Diagnostic Statistical Manual 5 (DSM5) criteria assessed by clinician interview\]
  • Mental disorder (based on DSM5 criteria assessed by clinician interview)
  • Willingness to receive treatment with office-based medication for opioid use disorder
  • Willingness to name at least 1 contact for follow up purposes
  • Enrollment in the ABOVE program

Exclusion

  • Pregnancy (urine testing if childbearing potential) or breast feeding
  • Suicidal or homicidal ideation that requires immediate attention
  • Cognitive dysfunction that precludes informed consent or research staff assessment that participant cannot understand interview questions

Key Trial Info

Start Date :

February 7 2019

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 12 2020

Estimated Enrollment :

115 Patients enrolled

Trial Details

Trial ID

NCT03812107

Start Date

February 7 2019

End Date

March 12 2020

Last Update

January 12 2022

Active Locations (1)

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1

Boston Medical Center

Boston, Massachusetts, United States, 02118