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Gateway Community Service | Jacksonville, FL

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

NYU Langone Health logo

NYU Langone Health

Status and phase

Enrolling
Phase 2

Conditions

Opioid Use Disorder (OUD)

Treatments

Drug: SL-BUP
Behavioral: MMD
Behavioral: MM
Drug: XR-BUP
Drug: XR-NTX
Behavioral: MMR

Study type

Interventional

Funder types

Other
Industry
NIH

Identifiers

NCT04464980
CTN-0100 (Other Identifier)
146193 (Other Identifier)
UG1DA015831 (U.S. NIH Grant/Contract)
20-PRS-057 (Other Identifier)
UG1DA013035 (U.S. NIH Grant/Contract)
19-01363

Details and patient eligibility

About

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.

Full 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.

Enrollment

2,190 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Retention Phase:

  1. 18 years of age or older;
  2. Meet DSM-5 criteria for current opioid use disorder (heroin, fentanyl or other synthetic opioids, and/or prescription opioids);
  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, SL-BUP-32mg, 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 an app delivering CM + CBT);
  6. In good-enough general health (meaning good enough health to be in outpatient treatment) as determined by the study medical clinician on the basis of medical history, review of systems, and physical/mental status exam, to permit treatment with XR-NTX or BUP;
  7. Willing and able to provide written informed consent;
  8. Able to speak English sufficiently to understand the study procedures;
  9. If female of childbearing potential, willing to practice an effective method of birth control for the duration of participation in the study (participants who become pregnant during the study will continue to be followed; treatment may be modified consistent with pregnancy).

Exclusion Criteria for Retention Phase:

  1. Serious medical, psychiatric, or co-occurring substance use disorder or concomitant medication 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. Examples include:

    1. 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;
    2. 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);
    3. Current severe alcohol, benzodiazepine, or other depressant or sedative hypnotic use, requiring a different level of care (e.g., hospitalization);
  2. Suicidal or homicidal ideation or behavior requiring a different level of care (e.g., hospitalization);

  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 (e.g., BMI>40, excess fat tissue over the buttocks, emaciation);

  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 that could prevent participation in study activities;

  9. Have used the reSET-O or CHESS Connections mHealth apps in the 3 months prior to consent;

  10. Other major reasons that might prevent an individual from participating in the study (e.g., a planned move out of the area).

Inclusion Criteria for Discontinuation Phase:

  1. 18 years of age or older;
  2. 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;
  3. Express the desire to discontinue MOUD after a shared decision-making discussion with the treating provider;
  4. 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);
  5. If currently taking buprenorphine, are willing to take either SL-BUP or XR-BUP if randomized to that condition;
  6. Willing to be randomized to either MM or to MMD;
  7. Able to provide written informed consent after discussion with their provider regarding the risks of discontinuation;
  8. Able to speak English sufficiently to understand the study procedures;
  9. 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 for Discontinuation Phase:

  1. 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:

    1. 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;
    2. 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);
  2. Suicidal or homicidal ideation or behavior requiring a different level of care (e.g., hospitalization);

  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 12 weeks;

  6. Meets current DSM-5 criteria for any current 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. Have used the Connections mHealth app in the 3 months prior to consent (other than Connections in the Retention Phase);

  9. Other major reasons that might prevent an individual from participating in the study (e.g., a planned move out of the area.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Factorial Assignment

Masking

None (Open label)

2,190 participants in 16 patient groups

Retention: SL-BUP standard dose + MM
Experimental group
Description:
Standard dose sublingual buprenorphine-naloxone (SL-BUP) 16mg/day target plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Treatment:
Behavioral: MM
Drug: SL-BUP
Retention: SL-BUP high dose + MM
Experimental group
Description:
High dose sublingual buprenorphine-naloxone (SL-BUP) 32mg/day target plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Treatment:
Behavioral: MM
Drug: SL-BUP
Retention: XR-BUP + MM
Experimental group
Description:
Extended-release injectable buprenorphine (XR-BUP) plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Treatment:
Drug: XR-BUP
Behavioral: MM
Retention: XR-NTX + MM
Experimental group
Description:
Extended-release injectable naltrexone (XR-NTX) plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Treatment:
Drug: XR-NTX
Behavioral: MM
Retention: SL-BUP standard dose + MMR
Experimental group
Description:
Standard dose sublingual buprenorphine-naloxone (SL-BUP) 16mg/day target plus MMR, consisting of Medical Management and usual counseling, plus a technology-based behavioral component.
Treatment:
Behavioral: MMR
Drug: SL-BUP
Retention: SL-BUP high dose + MMR
Experimental group
Description:
High dose sublingual buprenorphine-naloxone (SL-BUP) 32mg/day target plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
Treatment:
Behavioral: MMR
Drug: SL-BUP
Retention: XR-BUP + MMR
Experimental group
Description:
Extended-release injectable buprenorphine (XR-BUP) plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
Treatment:
Behavioral: MMR
Drug: XR-BUP
Retention: XR-NTX + MMR
Experimental group
Description:
Extended-release injectable naltrexone (XR-NTX) plus MMR, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
Treatment:
Behavioral: MMR
Drug: XR-NTX
Discontinuation: Discontinue SL-BUP with SL-BUP + MM
Experimental group
Description:
Start on SL-BUP, taper with SL-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Treatment:
Behavioral: MM
Drug: SL-BUP
Discontinuation: Discontinue SL-BUP with XR-BUP + MM
Experimental group
Description:
Start on SL-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Treatment:
Drug: XR-BUP
Behavioral: MM
Discontinuation: Discontinue XR-BUP with XR-BUP + MM
Experimental group
Description:
Start on XR-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Treatment:
Drug: XR-BUP
Behavioral: MM
Discontinuation: Discontinue XR-NTX with XR-NTX + MM
Experimental group
Description:
Start on XR-NTX, taper with XR-NTX, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Treatment:
Drug: XR-NTX
Behavioral: MM
Discontinuation: Discontinue SL-BUP with SL-BUP + MMD
Experimental group
Description:
Start on SL-BUP, taper with SL-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
Treatment:
Behavioral: MMD
Drug: SL-BUP
Discontinuation: Discontinue SL-BUP with XR-BUP + MMD
Experimental group
Description:
Start on SL-BUP, taper with XR-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
Treatment:
Drug: XR-BUP
Behavioral: MMD
Discontinuation: Discontinue XR-BUP with XR-BUP + MMD
Experimental group
Description:
Start on XR-BUP, taper with XR-BUP, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
Treatment:
Drug: XR-BUP
Behavioral: MMD
Discontinuation: Discontinue XR-NTX with XR-NTX + MMD
Experimental group
Description:
Start on XR-NTX, taper with XR-NTX, plus MMD, consisting of standard Medical Management and usual counseling, plus a technology-based behavioral component.
Treatment:
Drug: XR-NTX
Behavioral: MMD

Trial contacts and locations

21

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Central trial contact

Project Manager

Data sourced from clinicaltrials.gov

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