NIDA-CTN-0100: Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)

  • STATUS
    Recruiting
  • End date
    Jun 4, 2026
  • participants needed
    2630
  • sponsor
    NYU Langone Health
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Updated on 14 October 2022
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Summary

This is a two phase study investigating combinations of pharmacological and behavioral interventions to optimize the treatment of Opioid Use Disorder (OUD). The Retention Phase will assess strategies for improving retention on buprenorphine (BUP) and extended-release injectable naltrexone (XR-NTX). The Discontinuation Phase will assess which approaches are most likely to lead to long-term success (absence of relapse), and what characteristics of participants distinguish those who can safely discontinue Medications for Opioid Use Disorder (MOUD) from those who remain at risk of relapse and should not discontinue.

Description

The main objectives of this study are:

  1. To test strategies to improve retention in treatment on medications for opioid use disorder (MOUD), among patients initiating treatment for OUD.
  2. To test strategies to improve outcomes among patients who have achieved stable remission on MOUD and want to discontinue MOUD.
  3. To develop models to predict who is able to discontinue MOUD without relapse, based on patient characteristics, including duration of MOUD prior to discontinuation.

The study will have a multicenter, randomized, pragmatic non-blinded design. The study has two phases, a Retention Phase and a Discontinuation Phase.

Details
Condition Opioid Use Disorder (OUD)
Treatment XR-NTX, MM, MMR, SL-BUP, XR-BUP, MMD
Clinical Study IdentifierNCT04464980
SponsorNYU Langone Health
Last Modified on14 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

18 years of age or older
Have been receiving buprenorphine for OUD for at least the past year or XR-NTX pharmacotherapy for OUD for at least the past 6 months prior to consent for the Discontinuation Phase
Express the desire to discontinue MOUD after a shared decision-making discussion with the treating provider
Meet stability criteria, i.e., have abstained from opioids (other than buprenorphine), cocaine, methamphetamine, and non-prescribed benzodiazepines for the past ≥12 weeks, and do not meet DSM-5 criteria for current (≥12 weeks) alcohol use disorder (participants with cannabis use will be eligible)
If currently taking buprenorphine, are willing to take either SL-BUP or XR-BUP if randomized to that condition
Willing to be randomized to either MM or to MMD
Able to provide written informed consent after discussion with their provider regarding the risks of discontinuation
Able to speak English sufficiently to understand the study procedures
If female of childbearing potential, willing to practice an effective method of birth control while in the study and taking study medication (participants who become pregnant during the study will continue to be followed; treatment may be modified consistent with pregnancy)

Exclusion Criteria

Serious medical or psychiatric disorder or concomitant medication that, in the opinion of the study medical clinician, would make study participation hazardous to the participant or compromise study findings or would prevent the participant from completing the study. Examples include
Disabling or terminal medical illness (e.g., uncompensated heart failure, cirrhosis or end-stage liver disease) as assessed by medical history, review of systems, physical exam and/or laboratory assessments
Severe, untreated, or inadequately treated psychiatric condition (e.g., active psychosis, uncontrolled bipolar disorder) as assessed by history and/or clinical interview, requiring a different level of care (e.g., hospitalization)
Suicidal or homicidal ideation or behavior requiring a different level of care (e.g
For participants entering the study taking buprenorphine, presence of pain requiring or likely requiring ongoing pain management with buprenorphine or other opioids
hospitalization)
If female, currently pregnant or breastfeeding or planning on conception
Use of opioids (other than buprenorphine), cocaine, methamphetamine, or non-prescribed benzodiazepines in the past 12 weeks
Meets current DSM-5 criteria for any current alcohol use disorder
Are currently in jail, prison or other overnight facility as required by court of law or have pending legal action that could prevent participation in study activities
Have used the Connections mHealth app in the 3 months prior to consent
Other major reasons that might prevent an individual from participating in the study (e.g., a planned move out of the area
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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