SMART Trial for Buprenorphine-Naloxone Medication Assisted Treatment Adherence

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-01

Study Completion Date

2025-02-01

Brief Summary

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The purpose of this study is to compare the effectiveness of two different interventions for medication-assisted treatment (MAT) adherence: Contingency Management (CM) and Brief Motivational Interviewing + Substance Free Activities + Mindfulness (BSM).

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Detailed Description

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The investigators seek to compare the effectiveness of these two different interventions for MAT adherence by first refining and piloting CM and BSM adherence approaches, then conducting a Sequential Multiple Assignment Randomized Trial (SMART) to assess sequential, individual, and combined effects across MAT initiation and maintenance.

In order to tailor treatment to individual's needs, the study will follow a sequential multiple assignment randomized trial (SMART) design: In stage 1, participants are individually randomized (1:1) to BSM or CM. Adherent buprenorphine-naloxone participants complete treatment in the arm they were originally assigned to, but non-adherent participants are re-randomized (1:1) to either switch to the other intervention or add the other intervention in this part-factorial SMART.

Conditions

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Opioid-use Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

In stage 1, participants are individually randomized (1:1) to BSM or CM. At the end of stage 1, adherent buprenorphine-naloxone participants remain in their respective intervention group during phase 2 (maintenance phase of same approach), whereas non-adherent participants are randomized (individually and 1:1) to either switch or add the respective other intervention in this part-factorial SMART. Our primary outcome is buprenorphine-naloxone adherence by the end of stage 2. This sequential randomization based on past treatment success assures that the assigned treatment option at any point in time is independent of future potential outcomes and only conditional on the subject's history, i.e., the sequential ignorable treatment assumption is satisfied by design,108 in sharp distinction to observational data where patients chose to switch/add or not to switch/add and where this assumption remains untestable.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Contingency Management (CM)

CM is a behavioral method that employs external rewards for target behavior. Participants will receive gift cards for adhering to treatment (attending physician visits and being adherent to buprenorphine-naloxone) for their first 4 clinic visits.

Group Type ACTIVE_COMPARATOR

Contingency Management

Intervention Type BEHAVIORAL

Contingency management (CM) is a behavioral method that employs external rewards for target behavior. For this study, participants will receive gift cards for adhering to Medication-Assisted Treatment (attending physician visits and adhering to buprenorphine-naloxone as determined by urine toxicology panel) during their first four visits while randomized to this condition. Participants will draw a gift card from a fishbowl each visit they are adherent. Gift cards range from $25-$100.

Brief Motivational Interviewing + Substance Free Activities + Mindfulness (BSM)

Participants will receive the BSM intervention at 4 timepoints.

Group Type ACTIVE_COMPARATOR

Brief Motivational Interviewing + Substance Free Activities + Mindfulness

Intervention Type BEHAVIORAL

Brief Motivational Interviewing + Substance Free Activities + Mindfulness (BSM) is an intervention that uses Motivational Interviewing and Behavioral Economics strategies to increase the salience of delayed rewards by eliciting personal goals, developing opioid-free activities, and engaging in reward bundling and episodic future thinking. Participants will be offered a menu of substance free activities that has been developed in pilot work. Activities will be discussed, and participants will be asked to engage in selected activities as homework. Engagement in substance free activities will be assessed at each subsequent visit. Mindfulness components will also be included in the intervention.

BSM+CM

BSM+CM is a combination of the two other arms. Participants may be randomized to this arm only in stage 2 of the SMART design.

Group Type ACTIVE_COMPARATOR

Contingency Management

Intervention Type BEHAVIORAL

Contingency management (CM) is a behavioral method that employs external rewards for target behavior. For this study, participants will receive gift cards for adhering to Medication-Assisted Treatment (attending physician visits and adhering to buprenorphine-naloxone as determined by urine toxicology panel) during their first four visits while randomized to this condition. Participants will draw a gift card from a fishbowl each visit they are adherent. Gift cards range from $25-$100.

Brief Motivational Interviewing + Substance Free Activities + Mindfulness

Intervention Type BEHAVIORAL

Brief Motivational Interviewing + Substance Free Activities + Mindfulness (BSM) is an intervention that uses Motivational Interviewing and Behavioral Economics strategies to increase the salience of delayed rewards by eliciting personal goals, developing opioid-free activities, and engaging in reward bundling and episodic future thinking. Participants will be offered a menu of substance free activities that has been developed in pilot work. Activities will be discussed, and participants will be asked to engage in selected activities as homework. Engagement in substance free activities will be assessed at each subsequent visit. Mindfulness components will also be included in the intervention.

Interventions

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Contingency Management

Contingency management (CM) is a behavioral method that employs external rewards for target behavior. For this study, participants will receive gift cards for adhering to Medication-Assisted Treatment (attending physician visits and adhering to buprenorphine-naloxone as determined by urine toxicology panel) during their first four visits while randomized to this condition. Participants will draw a gift card from a fishbowl each visit they are adherent. Gift cards range from $25-$100.

Intervention Type BEHAVIORAL

Brief Motivational Interviewing + Substance Free Activities + Mindfulness

Brief Motivational Interviewing + Substance Free Activities + Mindfulness (BSM) is an intervention that uses Motivational Interviewing and Behavioral Economics strategies to increase the salience of delayed rewards by eliciting personal goals, developing opioid-free activities, and engaging in reward bundling and episodic future thinking. Participants will be offered a menu of substance free activities that has been developed in pilot work. Activities will be discussed, and participants will be asked to engage in selected activities as homework. Engagement in substance free activities will be assessed at each subsequent visit. Mindfulness components will also be included in the intervention.

Intervention Type BEHAVIORAL

Other Intervention Names

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CM BSM

Eligibility Criteria

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Inclusion Criteria

* Present with symptoms of Opioid Use Disorder
* Eligible of receipt of buprenorphine-naloxone medication as determined by Study Doctor
* Access to a telephone