Active, not recruiting
Phase 2
Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)
Condition(s) studied
Opioid Use Disorder (OUD)
Investigational drug(s) / intervention(s)
SL-BUP: Daily dosing of sublingual buprenorphine-naloxone
XR-BUP: Weekly/monthly dosing of extended-release injectable buprenorphine
XR-NTX: Monthly dosing of extended-release injectable naltrexone
MM: MM consists of standard Medical Management and the usual counseling at the treatment program.
MMR: MMR consists of Medical Management and usual counseling, plus a technology-based behavioral component.
MMD: MMD consists of Medical Management and usual counseling, plus a technology-based behavioral component.
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Retention: Continuous retention in MOUD treatment through 26 weeks — Retention: from randomization through week 26
Binary (yes/no). Continuously enrolled in maintenance treatment on one or more of the evidence-based MOUD modalities (e.g., SL-BUP, XR-BUP, XR-NTX, or methadone maintenance) with no more than a 28-day gap on MOUD over the 26-week period.
- Discontinuation: Completed Discontinuation without Relapse — Discontinuation: from randomization through week 24 follow up
Binary (yes/no). Discontinuing MOUD during the taper period, no return to MOUD, and no relapse to opioid use, either during the taper (up to 48 weeks for those entering on BUP or 24 weeks for those entering on XR-NTX) or during the 24 weeks after MOUD is discontinued.
Trial sites (21)
| Facility | City | Region | Status |
| University of Arkansas for Medical Sciences (UAMS) / Center for Addiction Services and Treatment (CAST) |
Little Rock |
Arkansas |
|
| Tarzana Treatment Centers, Inc. |
Tarzana |
California |
|
| Liberation Programs, Inc. |
Bridgeport |
Connecticut |
|
| Operation PAR |
Clearwater |
Florida |
|
| Gateway Community Services |
Jacksonville |
Florida |
|
| Aspire Health Partners |
Orlando |
Florida |
|
| Mountain Manor / Maryland Treatment Centers |
Baltimore |
Maryland |
|
| McLean Hospital |
Belmont |
Massachusetts |
|
| Stanley Street Treatment and Resources, Inc. |
Fall River |
Massachusetts |
|
| Square Medical Group, LLC |
Newton |
Massachusetts |
|
| Gibson Center for Behavioral Change |
Cape Girardeau |
Missouri |
|
| Dartmouth Hitchcock - ATP |
Lebanon |
New Hampshire |
|
| University of New Mexico Addiction and Substance Abuse Program |
Albuquerque |
New Mexico |
|
| Bellevue Hospital Center |
New York |
New York |
|
| Adapt Integrated Health Care |
Roseburg |
Oregon |
|
| Adapt Integrated Health Care |
Winston |
Oregon |
|
| Center for Psychiatric and Chemical Dependency Services (CPCDS) |
Pittsburgh |
Pennsylvania |
|
| Internal Medicine Recovery Engagement Program (IM-REP) |
Pittsburgh |
Pennsylvania |
|
| Shoreline Behavioral Health Services |
Conway |
South Carolina |
|
| Huntsman Mental Health Institute / University of Utah |
Salt Lake City |
Utah |
|
| Chestnut Ridge Center |
Morgantown |
West Virginia |
|
More NYU Langone Health trials in Mexico
Other trials for the same condition