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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA062408 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Buprenorphine, a medication for opioid use disorder (MOUD), is associated with decreased opioid overdose and all-cause mortality. Treatment outcomes improve if patients remain on MOUD for at least six months, a period recommended by expert guidelines, although most studies report retention on MOUD of 50-65% at 3-6 months. Psychosocial interventions have the potential to improve MOUD treatment retention particularly when applied in combination in efficient delivery systems.
The objective of this study is to develop an effective and efficient multicomponent intervention to increase buprenorphine retention at 6 months through an optimization trial.
The investigators will leverage the Multiphase Optimization STrategy (MOST) framework for developing, optimizing, and evaluating a multicomponent behavioral intervention. The impact of three psychosocial intervention components on buprenorphine treatment retention at six months will be tested by recruiting persons initiating buprenorphine from office-based addiction treatment settings and randomizing them in a balanced 2x2x2 factorial design to some combination of the following 3 intervention components:
All participants will receive usual care, including brief advice to continue treatment for at least 6 months.
The observed main and interaction effects for the 3 candidate psychosocial interventions will guide the selection of components to be included in an optimized intervention (the end goal of this project).
Results from this study will be twofold:
The long-term impact will be to establish a psychosocial intervention package that improves retention in buprenorphine treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Behavioral Activation | Experimental | Participants in this arm will receive the behavioral activation intervention. |
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| Attendance Reinforcement | Experimental | Participants in this arm will receive the Attendance Reinforcement intervention. |
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| Peer-Delivered Motivational Interviewing | Experimental | Participants in this arm will receive the Peer-Delivered Motivational Interviewing Intervention. |
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| Behavioral Activation + Attendance Reinforcement | Experimental | Participants in this arm will receive the Behavioral Activation and Attendance Reinforcement interventions. |
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| Behavioral Activation + Peer-Delivered Motivational Interviewing | Experimental | Participants in this arm will receive the Behavioral Activation and Peer-Delivered Motivational Interviewing interventions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral Activation (BA) | Behavioral | Trained study interventionists will deliver the manualized BA intervention aimed at increasing meaningful and enjoyable non-substance-related activities in early recovery. This intervention will include 12 individual sessions delivered to participants every other week for 6 months. The BA intervention will be delivered remotely by telephone or video visit to minimize treatment burden on patients. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with buprenorphine retention | Buprenorphine retention will be defined as any of the following: 1) EHR confirmation of a prescription whose end date extends beyond the day of the 6-month assessment OR long-acting injectable buprenorphine (LAIB) administration within the last 4 weeks (for monthly Sublocade or Brixadi) or within the last 7 days (for weekly Brixadi); 2) Self-report of an active buprenorphine prescription or active LAIB administration (as previously defined); 3) Verification of medication including visualization of a pill bottle, film packet, or verification of a record of an LAIB administration event (by photo or video confirmation) for persons who change their care to another clinic during the study period | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
-Be receiving hospice or other end of life medical care
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael Stein, MD | Contact | (617) 638-5042 | mdstein@bu.edu | |
| Sally Bendiks, MPH | Contact | (617) 414-3802 | Sally.Bendiks@bmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Michael Stein, MD | BUSPH, Health Law, Policy & Management | Principal Investigator |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Attendance Reinforcement + Peer-Delivered Motivational Interviewing | Experimental | Participants in this arm will receive the Attendance Reinforcement and Peer-Delivered Motivational Interviewing interventions. |
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| Behavioral Activation + Attendance Reinforcement + Peer-Delivered Motivational Interviewing | Experimental | Participants in this arm will receive the Behavioral Activation, Attendance Reinforcement, and Peer-Delivered Motivational Interviewing interventions. |
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| Treatment As Usual | No Intervention | Participants randomized to this arm will receive usual care at their office based addiction treatment facility. |
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| Attendance Reinforcement (AR) | Behavioral | A voucher incentive protocol will be implemented with increasing rewards based on clinical attendance at outpatient addiction treatment visits. The timing of clinical visits will be determined by site-specific usual care practices at both sites. Participants are expected to earn a range of payments for visit attendance according to their unique clinical schedule (which is dictated by their addiction medicine clinical team, not by research investigators). |
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| Peer-Delivered Motivational Interviewing (PDMI) | Behavioral | Trained study peer recovery coaches will deliver a multi-session intervention aimed at increasing treatment confidence for treatment continuation and providing social support during early recovery. The peer recovery coach will deliver brief MI (20-minute) individual sessions remotely every other week over the 6-month period (total 12 sessions). Peer interventionists will also be informed about local recovery resources to provide navigation support individually. PDMI will be delivered remotely by telephone or video visit. |
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