Optimizing Retention Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Opioid Use Disorder
  • Age: Between 18 Year(s) - 99 Year(s)
  • Gender: Male or Female
  • Other Inclusion Criteria:
    Retention Phase
    1. Participants will provide written informed consent
    2. Meet DSM-5 criteria for current opioid use disorder
    3. Seeking treatment for opioid use disorder and choosing either buprenorphine (BUP) or extended-release injection naltrexone (XR- NTX)
    4. If choosing buprenorphine, willing to be randomized to SL- BUP-16mg film, SL-BUP-32mg film, or XR-BUP
    5. Willing to be randomized to either MM (standard medical management plus counseling treatment as usual available at the site) or MMR (MM plus usual counseling and access to the reSET mHealth app)
    6. In good-enough general health
    7. Able to speak English sufficiently to understand the study procedures
    8. If female of childbearing potential, willing to practice an effective method of birth control for the duration of participation in the study
    9. Willing to give a blood sample for the genetics study
    Discontinuation Phase
    1. Have received buprenorphine for OUD for at least the past year or XR-NTX pharmacotherapy for OUD
    2. Express the desire to discontinue MOUD after a shared decision- making discussion with the treating provider
    3. Meet stability criteria as per protocol
    4. (If currently taking buprenorphine) are willing to take either SL- BUP film or XR-BUP if randomized to that condition
    5. Willing to be randomized to either MM or to MMA
    6. Able to provide written informed consent after discussion with their provider regarding the risks of discontinuation
    7. If not entering from the Retention Phase, willing to have blood drawn for the genetics study
    8. If female of childbearing potential, willing to practice an effective method of birth control for the duration of participation in the study

You may not be eligible for this study if the following are true:

  • Retention Phase
    1. Serious medical, psychiatric, or co-occurring substance use disorder that, in the opinion of the study medical clinician, makes the patient not appropriate for outpatient treatment with buprenorphine or XR- NTX but instead requires a higher or different level of care
    2. Suicidal or homicidal ideation or behavior requiring a different level of care
    3. Known allergy or sensitivity to preferred medication or its components
    4. Maintenance on methadone at the time of signing consent
    5. For those preferring XR-NTX, presence of pain of sufficient severity as to require ongoing pain management with opioids
    6. For those preferring XR-NTX, body habitus that, in the judgment of the study physician, precludes safe intramuscular injection of XR-NTX
    7. If female, currently pregnant or breastfeeding or planning on conception
    8. Are currently in jail, prison or other overnight facility as required by court of law or have pending legal action
    9. Other major reasons that might prevent an individual from participating in the study
    Discontinuation Phase
    1. Serious medical or psychiatric disorder 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.
    2. Suicidal or homicidal ideation requiring a different level of care
    3. For participants entering the study taking buprenorphine, presence of pain requiring or likely requiring ongoing pain management with buprenorphine or other opioids
    4. If female, currently pregnant or breastfeeding or planning on conception
    5. Use of opioids (other than buprenorphine), cocaine, methamphetamine, or non-prescribed benzodiazepines in the past 3 months
    6. Meets current DSM-5 criteria for alcohol use disorder
    7. 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
    8. Other major reasons that might prevent an individual from participating in the study



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