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

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ClinicalTrials.gov Identifier: NCT04464980
Recruitment Status : Recruiting
First Posted : July 9, 2020
Last Update Posted : June 29, 2021
Sponsor:
Collaborators:
New York State Psychiatric Institute
Columbia University
Harvard Medical School
Mclean Hospital
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Information provided by (Responsible Party):
NYU Langone Health

Brief 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.

Condition or disease Intervention/treatment Phase
Opioid Use Disorder (OUD) Drug: SL-BUP Drug: XR-BUP Drug: XR-NTX Behavioral: MM Behavioral: MMR Behavioral: MMD Phase 2

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2630 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Intervention Model Description: Retention Phase: 3x2 for BUP; 1x2 for XR-NTX; Discontinuation Phase: 2x2 for SL-BUP; 1x2 for XR-BUP; 1x2 for XR-NTX
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: NIDA-CTN-0100: Optimizing Retention, Duration and Discontinuation Strategies for Opioid Use Disorder Pharmacotherapy (RDD)
Actual Study Start Date : June 7, 2021
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : February 2026

Arm Intervention/treatment
Experimental: Retention: SL-BUP standard dose + MM
Standard dose sublingual buprenorphine-naloxone (SL-BUP) 16mg/day target plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Drug: SL-BUP
Daily dosing of sublingual buprenorphine-naloxone
Other Names:
  • sublingual buprenorphine
  • Suboxone

Behavioral: MM
MM consists of standard Medical Management and the usual counseling at the treatment program.

Experimental: Retention: SL-BUP high dose + MM
High dose sublingual buprenorphine-naloxone (SL-BUP) 32mg/day target plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Drug: SL-BUP
Daily dosing of sublingual buprenorphine-naloxone
Other Names:
  • sublingual buprenorphine
  • Suboxone

Behavioral: MM
MM consists of standard Medical Management and the usual counseling at the treatment program.

Experimental: Retention: XR-BUP + MM
Extended-release injectable buprenorphine (XR-BUP) plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Drug: XR-BUP
Weekly/monthly dosing of extended-release injectable buprenorphine
Other Names:
  • extended-release buprenorphine
  • CAM2038
  • Brixadi

Behavioral: MM
MM consists of standard Medical Management and the usual counseling at the treatment program.

Experimental: Retention: XR-NTX + MM
Extended-release injectable naltrexone (XR-NTX) plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Drug: XR-NTX
Monthly dosing of extended-release injectable naltrexone
Other Names:
  • extended-release naltrexone
  • Vivitrol

Behavioral: MM
MM consists of standard Medical Management and the usual counseling at the treatment program.

Experimental: Retention: SL-BUP standard dose + MMR
Standard dose sublingual buprenorphine-naloxone (SL-BUP) 16mg/day target plus MMR, consisting of Medical Management and usual counseling, plus Pear-002a, a technology-based behavioral component, to support retention and abstinence.
Drug: SL-BUP
Daily dosing of sublingual buprenorphine-naloxone
Other Names:
  • sublingual buprenorphine
  • Suboxone

Behavioral: MMR
MMR consists of Medical Management and usual counseling, plus Pear-002a, a technology-based behavioral component, to support retention and abstinence.

Experimental: Retention: SL-BUP high dose + MMR
High dose sublingual buprenorphine-naloxone (SL-BUP) 32mg/day target plus MMR, consisting of standard Medical Management and usual counseling, plus Pear-002a, a technology-based behavioral component, to support retention and abstinence.
Drug: SL-BUP
Daily dosing of sublingual buprenorphine-naloxone
Other Names:
  • sublingual buprenorphine
  • Suboxone

Behavioral: MMR
MMR consists of Medical Management and usual counseling, plus Pear-002a, a technology-based behavioral component, to support retention and abstinence.

Experimental: Retention: XR-BUP + MMR
Extended-release injectable buprenorphine (XR-BUP) plus MMR, consisting of standard Medical Management and usual counseling, plus Pear-002a, a technology-based behavioral component, to support retention and abstinence.
Drug: XR-BUP
Weekly/monthly dosing of extended-release injectable buprenorphine
Other Names:
  • extended-release buprenorphine
  • CAM2038
  • Brixadi

Behavioral: MMR
MMR consists of Medical Management and usual counseling, plus Pear-002a, a technology-based behavioral component, to support retention and abstinence.

Experimental: Retention: XR-NTX + MMR
Extended-release injectable naltrexone (XR-NTX) plus MMR, consisting of standard Medical Management and usual counseling, plus Pear-002a, a technology-based behavioral component, to support retention and abstinence.
Drug: XR-NTX
Monthly dosing of extended-release injectable naltrexone
Other Names:
  • extended-release naltrexone
  • Vivitrol

Behavioral: MMR
MMR consists of Medical Management and usual counseling, plus Pear-002a, a technology-based behavioral component, to support retention and abstinence.

Experimental: Discontinuation: Discontinue SL-BUP with SL-BUP + MM
Start on SL-BUP, taper with SL-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Drug: SL-BUP
Daily dosing of sublingual buprenorphine-naloxone
Other Names:
  • sublingual buprenorphine
  • Suboxone

Behavioral: MM
MM consists of standard Medical Management and the usual counseling at the treatment program.

Experimental: Discontinuation: Discontinue SL-BUP with XR-BUP + MM
Start on SL-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Drug: XR-BUP
Weekly/monthly dosing of extended-release injectable buprenorphine
Other Names:
  • extended-release buprenorphine
  • CAM2038
  • Brixadi

Behavioral: MM
MM consists of standard Medical Management and the usual counseling at the treatment program.

Experimental: Discontinuation: Discontinue XR-BUP with XR-BUP + MM
Start on XR-BUP, taper with XR-BUP, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Drug: XR-BUP
Weekly/monthly dosing of extended-release injectable buprenorphine
Other Names:
  • extended-release buprenorphine
  • CAM2038
  • Brixadi

Behavioral: MM
MM consists of standard Medical Management and the usual counseling at the treatment program.

Experimental: Discontinuation: Discontinue XR-NTX with XR-NTX + MM
Start on XR-NTX, taper with XR-NTX, plus MM, consisting of standard Medical Management and usual counseling at the treatment program.
Drug: XR-NTX
Monthly dosing of extended-release injectable naltrexone
Other Names:
  • extended-release naltrexone
  • Vivitrol

Behavioral: MM
MM consists of standard Medical Management and the usual counseling at the treatment program.

Experimental: Discontinuation: Discontinue SL-BUP with SL-BUP + MMD
Start on SL-BUP, taper with SL-BUP, plus MMD, consisting of standard Medical Management and usual counseling plus Connections, an app-based behavioral component to support discontinuation and recovery.
Drug: SL-BUP
Daily dosing of sublingual buprenorphine-naloxone
Other Names:
  • sublingual buprenorphine
  • Suboxone

Behavioral: MMD
MMD consists of Medical Management and usual counseling plus Connections, an app-based behavioral component to support discontinuation and recovery.

Experimental: Discontinuation: Discontinue SL-BUP with XR-BUP + MMD
Start on SL-BUP, taper with XR-BUP, plus MMD, consisting of standard Medical Management and usual counseling plus Connections, an app-based behavioral component to support discontinuation and recovery.
Drug: XR-BUP
Weekly/monthly dosing of extended-release injectable buprenorphine
Other Names:
  • extended-release buprenorphine
  • CAM2038
  • Brixadi

Behavioral: MMD
MMD consists of Medical Management and usual counseling plus Connections, an app-based behavioral component to support discontinuation and recovery.

Experimental: Discontinuation: Discontinue XR-BUP with XR-BUP + MMD
Start on XR-BUP, taper with XR-BUP, plus MMD, consisting of standard Medical Management and usual counseling plus Connections, an app-based behavioral component to support discontinuation and recovery.
Drug: XR-BUP
Weekly/monthly dosing of extended-release injectable buprenorphine
Other Names:
  • extended-release buprenorphine
  • CAM2038
  • Brixadi

Behavioral: MMD
MMD consists of Medical Management and usual counseling plus Connections, an app-based behavioral component to support discontinuation and recovery.

Experimental: Discontinuation: Discontinue XR-NTX with XR-NTX + MMD
Start on XR-NTX, taper with XR-NTX, plus MMD, consisting of standard Medical Management and usual counseling plus Connections, an app-based behavioral component to support discontinuation and recovery.
Drug: XR-NTX
Monthly dosing of extended-release injectable naltrexone
Other Names:
  • extended-release naltrexone
  • Vivitrol

Behavioral: MMD
MMD consists of Medical Management and usual counseling plus Connections, an app-based behavioral component to support discontinuation and recovery.




Primary Outcome Measures :
  1. Retention: Continuous retention in MOUD treatment at 26 weeks [ Time Frame: Retention: at 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 in MOUD over the 26-week period.

  2. Discontinuation: Completed Discontinuation without Relapse [ Time Frame: Discontinuation: at 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.


Secondary Outcome Measures :
  1. Retention KS1: Weekly opioid abstinence [ Time Frame: Retention: through week 26 ]
    Weekly opioid abstinence (measured by Timeline Followback, not contradicted by toxicology test). Repeated yes/no measure for each of weeks 3 through 26.

  2. Retention KS2: Treatment effectiveness [ Time Frame: Retention: at week 26 ]
    Retention treatment effectiveness, measured by the Treatment Effectiveness Assessment (TEA, Ling et. al, 2012); a brief instrument to assess patient progress in treatment and recovery along 4 domains (substance use, health, lifestyle and community) at week 26.

  3. Discontinuation KS1: Other discontinuation outcomes [ Time Frame: Discontinuation: at week 24 follow up ]
    Participants who did not meet the criteria for the primary outcome (Completed Discontinuation without Relapse), will be subcategorized into 3 other outcome categories: 1) Did not Complete Discontinuation (i.e., MOUD is continued or discontinued and then restarted within the next 6 months) without Relapse; 2) Completed Discontinuation followed by Relapse; or 3) Did not Complete Discontinuation and Relapse (i.e., relapse while still on MOUD).

  4. DSK2: Treatment effectiveness [ Time Frame: Discontinuation: week 24 follow up ]
    Discontinuation treatment effectiveness, measured by the Treatment Effectiveness Assessment (TEA, Ling et. al, 2012); a brief instrument to assess patient progress in treatment and recovery along 4 domains (substance use, health, lifestyle and community) at week 24. Measured at the end of taper (EOT): up to 24 weeks for tapers with XR-NTX and up to 48 weeks for tapers with BUP; and at the week 24 follow up (primary outcome timepoint).


Other Outcome Measures:
  1. R-Other 1a: Continuous opioid abstinence-weeks 23-26 [ Time Frame: Retention: weeks 23-26 ]
    Binary indicator of continuous abstinence from opioids in weeks 23 to 26 (measured by Timeline Followback, not contradicted by toxicology test)

  2. R-Other 1b: Continuous opioid abstinence-weeks 47-50 [ Time Frame: Retention: weeks 47-50 ]
    Binary indicator of continuous abstinence from opioids in weeks 47 to 50 (measured by Timeline Followback, not contradicted by toxicology test)

  3. R-Other 1c: Continuous opioid abstinence-weeks 71-74 [ Time Frame: Retention: weeks 71-74 ]
    Binary indicator of continuous abstinence from opioids in weeks 71 to 74 (measured by Timeline Followback, not contradicted by toxicology test)

  4. R-Other 2: Weekly opioid abstinence [ Time Frame: Retention: weeks 27-74 ]
    Weekly opioid abstinence (measured by Timeline Followback, not contradicted by toxicology test). Repeated yes/no measure for each of weeks 27 through 74.

  5. R-Other 3: Weekly abstinence from other substance use [ Time Frame: Retention: weeks 0-74 ]
    Weekly abstinence from other substance use (measured by Timeline Followback, not contradicted by toxicology test)

  6. R-Other 4: Craving [ Time Frame: Retention: weeks 0-98 ]
    Craving, measured by the Opioid Craving Scale

  7. R-Other 5a: Stable abstinence at week 26 [ Time Frame: Retention: week 26 ]
    Stable abstinence, as defined by the same stability criteria as in the Discontinuation Phase (point prevalence stability at week 26), i.e., past ≥12 weeks of consecutive abstinence from opioids (other than prescribed buprenorphine), methamphetamine, and cocaine, no non-prescribed benzodiazepine use, and no current (≥12 weeks) alcohol use disorder (any severity); measured by Timeline Followback, not contradicted by toxicology test (both repeated measures), and DSM-5 checklist for current alcohol use disorder (which is performed only when these abstinence criteria are met)

  8. R-Other 5b: Stable abstinence at week 50 [ Time Frame: Retention: week 50 ]
    Stable abstinence, as defined by the same stability criteria as in the Discontinuation Phase (point prevalence stability at week 50), i.e., past ≥12 weeks of consecutive abstinence from opioids (other than prescribed buprenorphine), methamphetamine, and cocaine, no non-prescribed benzodiazepine use, and no current (≥12 weeks) alcohol use disorder (any severity); measured by Timeline Followback, not contradicted by toxicology test (both repeated measures), and DSM-5 checklist for current alcohol use disorder (which is performed only when these abstinence criteria are met)

  9. R-Other 5c: Stable abstinence at week 74 [ Time Frame: Retention: week 74 ]
    Stable abstinence, as defined by the same stability criteria as in the Discontinuation Phase (point prevalence stability at week 74), i.e., past ≥12 weeks of consecutive abstinence from opioids (other than prescribed buprenorphine), methamphetamine, and cocaine, no non-prescribed benzodiazepine use, and no current (≥12 weeks) alcohol use disorder (any severity); measured by Timeline Followback, not contradicted by toxicology test (both repeated measures), and DSM-5 checklist for current alcohol use disorder (which is performed only when these abstinence criteria are met)

  10. R-Other 6: Retention in MOUD at week 50 [ Time Frame: Retention: week 50 ]
    Point prevalence of retention in MOUD treatment (defined as no gap of 28 days or more in MOUD) at 50 weeks after date of randomization (binary, measured by Timeline Followback)

  11. R-Other 7: Retention in MOUD at week 74 [ Time Frame: Retention: week 74 ]
    Point prevalence of retention in MOUD treatment at 74 weeks after date of randomization, measured by TLFB

  12. R-Other 8: Dropout from MOUD treatment [ Time Frame: Retention: weeks 0-74 ]
    Dropout from MOUD treatment (time to event), i.e., a gap of 28 or more days in MOUD, event to have started at the beginning of the 28-day gap (measured by Timeline Followback)

  13. R-Other 9: Depression [ Time Frame: Retention: weeks 0-26 ]
    Depression (measured by the Patient Health Questionnaire (PHQ) 9) over the first 26 weeks

  14. R-Other 10: Anxiety [ Time Frame: Retention: weeks 0-26 ]
    Anxiety, measured by the measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Preference (PROPr) over the first 26 weeks

  15. R-Other 11: Stress [ Time Frame: Retention: weeks 0-26 ]
    Stress, measured by the Perceived Stress Scale, over the first 26 weeks

  16. R-Other 12: Pain [ Time Frame: Retention: weeks 0-26 ]
    Pain, measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Preference (PROPr), over the first 26 weeks

  17. R-Other 13: Recovery capital [ Time Frame: Retention: weeks 0-26 ]
    Recovery capital, measured by the Brief Assessment of Recovery Capital (BARC) 10 item scale, over the first 26 weeks

  18. R-Other 14: Negative consequences of opioid use [ Time Frame: Retention: weeks 0-26 ]
    Negative consequences of opioid use, measured by the Short Inventory of Problems-Revised, over the first 26 weeks

  19. R-Other 15: Sexual risk [ Time Frame: Retention: weeks 0-26 ]
    Sexual risk, measured by two questions regarding sexual behavior, over the first 26 weeks

  20. R-Other 16: Rate of incarceration [ Time Frame: Retention: weeks 0-26 ]
    Rate of incarcerations, collected on the Non-Medical and Other Services form, over the first 26 weeks

  21. R-Other 17: Rate of homelessness [ Time Frame: Retention: weeks 0-26 ]
    Rate of homelessness, collected on the Study Demographics form, over the first 26 weeks

  22. D-Other 1: Relapse [ Time Frame: Discontinuation: during taper and through week 24 follow up ]
    Relapse (time to event): defined as self-reported opioid use on more than 4 days in any consecutive 28-day period (event to begin on the first day of use), or 2 or more consecutive opioid-positive drug tests (event to begin with the first opioid-positive test) or any self-reported injection drug use (whichever comes first).

  23. D-Other 2: Withdrawal symptoms [ Time Frame: Discontinuation: during taper and through week 24 follow up ]
    Withdrawal symptoms, measured by Subjective Opioid Withdrawal Scale (SOWS), during taper and follow up

  24. D-Other 3: Craving [ Time Frame: Discontinuation: during taper and through week 24 follow up ]
    Craving, measured by the Opioid Craving Scale, during taper and follow up

  25. D-Other 4: Depression [ Time Frame: Discontinuation: during taper and through week 24 follow up ]
    Depression, measured by the Patient Health Questionnaire (PHQ) 9 item, during taper and follow up

  26. D-Other 5: Anxiety [ Time Frame: Discontinuation: during taper and through week 24 follow up ]
    Anxiety, measured by the measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Preference (PROPr), during taper and follow up

  27. D-Other 6: Stress [ Time Frame: Discontinuation: during taper and through week 24 follow up ]
    Stress, measured by the Perceived Stress Scale, during taper and follow up

  28. D-Other 7: Pain [ Time Frame: Discontinuation: during taper and through week 24 follow up ]
    Pain, measured by the measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Preference (PROPr), during taper and follow up

  29. D-Other 8a: Recovery capital (BARC-10) [ Time Frame: Discontinuation: during taper and through week 24 follow up ]
    Recovery capital, measured by the Brief Assessment of Recovery Capital (BARC) 10 item scale, during taper and follow up

  30. D-Other 8b: Recovery capital (RCS) [ Time Frame: Discontinuation: during taper and through week 24 follow up ]
    Recovery capital, measured by the Recovery Capital Scale; six additional questions more specific to participants with OUD, during taper and follow up

  31. D-Other 9: Negative consequences of opioid use [ Time Frame: Discontinuation: during taper and through week 24 follow up ]
    Negative consequences of opioid use, measured by the Short Inventory of Problems-Revised, during taper and follow up

  32. D-Other 10: Sexual risk [ Time Frame: Discontinuation: during taper and through week 24 follow up ]
    Sexual risk, measured by two questions regarding sexual behavior, during taper and follow up

  33. D-Other 11: Rate of incarceration [ Time Frame: Discontinuation: during taper and through week 24 follow up ]
    Incarcerations, collected on the Non-Medical and Other Services form, during taper and follow up

  34. D-Other 12: Rate of homelessness [ Time Frame: Discontinuation: during taper and through week 24 follow up ]
    Homelessness, collected on the Study Demographics form, during taper and follow up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 the Pear-002a mHealth app);
  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 or reSET-O 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;
  9. Other major reasons that might prevent an individual from participating in the study (e.g., a planned move out of the area.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04464980


Contacts
Layout table for location contacts
Contact: Patricia Novo, MPA, MPH 646-754-4786 patricia.novo@nyulangone.org
Contact: RDD Contacts RDD@nyulangone.org

Locations
Layout table for location information
United States, Connecticut
Liberation Programs, Inc. Recruiting
Bridgeport, Connecticut, United States, 06850
Contact: Mary Beth Pamias    203-520-6392    marybeth.dezenzo@liberationprograms.org   
Contact: Joanne Montgomery    203-913-6439    joanne.montgomery@liberationprograms.org   
Principal Investigator: John Hamilton, LMFT, LADC         
United States, Florida
Gateway Community Services Recruiting
Jacksonville, Florida, United States, 32204
Contact: Jenna Gosden    904-387-4661 ext 1090    jgosden@gwjax.com   
Contact: Sarah Kim, MA    904-387-4661 ext 1073    skim@gwjax.com   
Principal Investigator: Candace Hodgkins, PhD         
Sub-Investigator: Raymond Pomm, MD         
United States, Maryland
Mountain Manor / Maryland Treatment Centers Recruiting
Baltimore, Maryland, United States, 21229
Contact: Jennifer Carrano, PhD    410-233-1400    jcarrano@mountainmanor.org   
Contact: Kevin Wenzel, PhD    410-233-1400    kwenzel@mountainmanor.org   
Principal Investigator: Marc Fishman, MD         
Sub-Investigator: Syed Asad Hassan Bokhari, MD         
Sub-Investigator: Ann Bennett Bruner, MD         
Sub-Investigator: Jennifer Carrano, PhD         
Sub-Investigator: Kevin Wenzel, PhD         
United States, Massachusetts
Stanley Street Treatment and Resources, Inc. Recruiting
Fall River, Massachusetts, United States, 02720
Contact: Michelle Rapoza    508-324-3522    mrapoza@sstar.org   
Contact: Call Center    508-679-5222    research@sstar.org   
Principal Investigator: Genie L Bailey, MD         
Square Medical Group, LLC Recruiting
Watertown, Massachusetts, United States, 02472
Contact: Chloe J Jordan, PhD    617-916-5069 ext 307    cjjordan@mclean.harvard.edu   
Contact: Hannah Shapiro    617-916-5069 ext 307    hshapiro2@mgh.harvard.edu   
Principal Investigator: Natalie Lender, MD         
Sub-Investigator: Gregory Labun, MD         
Sub-Investigator: Jungjin Kim, MD         
Sub-Investigator: Andrew Peckham, PhD         
Sub-Investigator: Catherine Trinh, BA         
United States, Missouri
Gibson Recovery Center, Inc. Recruiting
Cape Girardeau, Missouri, United States, 63703
Contact: Ashley Naeger, MSW    573-332-0416 ext 158    naegera@gibsonrecovery.org   
Principal Investigator: Ashley Naeger, MSW         
Sub-Investigator: John Gary         
United States, New York
Bellevue Hospital Center Recruiting
New York, New York, United States, 10016
Contact: Research Coordinator    646-501-4138    Bellevue.RDDStudy@nyulangone.org   
Principal Investigator: Mathew Kladney, MD         
United States, Oregon
Adapt Recruiting
Roseburg, Oregon, United States, 97470
Contact: Mark Vickers    541-492-4550 ext 4701    markv@adaptoregon.org   
Principal Investigator: Cora Hart, PhD         
United States, Utah
Huntsman Mental Health Institute / University of Utah Not yet recruiting
Salt Lake City, Utah, United States, 84108
Contact: Research Coordinator       RDDstudy@utah.edu   
Contact: Gina Gregovich, BA    801-585-6968    gina.gregovich@hsc.utah.edu   
Principal Investigator: Elizabeth Howell, MD         
Sub-Investigator: Jeremy Thueson, MD         
United States, West Virginia
Chestnut Ridge Center Recruiting
Morgantown, West Virginia, United States, 26505
Contact: Lacey Kelley, BSN    304-276-3828    lkelley5@hsc.wvu.edu   
Principal Investigator: Laura Lander, MSW, AADC         
Sponsors and Collaborators
NYU Langone Health
New York State Psychiatric Institute
Columbia University
Harvard Medical School
Mclean Hospital
National Institute on Drug Abuse (NIDA)
The Emmes Company, LLC
Investigators
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Principal Investigator: Edward V Nunes, MD New York State Psychiatric Institute/Columbia University Irving Medical Center
Principal Investigator: John Rotrosen, MD NYU Grossman School of Medicine
Principal Investigator: Roger Weiss, MD Harvard Medical School/McLean Hospital
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT04464980    
Other Study ID Numbers: 19-01363
CTN-0100 ( Other Identifier: NIDA Clinical Trials Network )
UG1DA013035 ( U.S. NIH Grant/Contract )
UG1DA015831 ( U.S. NIH Grant/Contract )
20-PRS-057 ( Other Identifier: Biomedical Research Alliance of New York (BRANY) sIRB )
146193 ( Other Identifier: FDA/IND# )
First Posted: July 9, 2020    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

This study will comply with the NIH Data Sharing Policy and Implementation Guidance (https://grants.nih.gov/grants/policy/data_sharing/data_sharing_guidance.htm) and (for HEAL-funded studies) the HEAL Public Access and Data Sharing Policy (https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/research/heal-public-access-data-sharing-policy).

Primary data for this study will be available to the public in the NIDA data repository. For more details on data sharing please visit https://datashare.nida.nih.gov/.

The primary outcome(s) publication will be included along with study underlying primary data in the data share repository, and it will also be deposited in PubMed Central http://www.pubmedcentral.nih.gov/ per NIH Policy (http://publicaccess.nih.gov/).

Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
URL: https://datashare.nida.nih.gov

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Naltrexone
Buprenorphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Narcotic Antagonists
Alcohol Deterrents