SMART Trial for Buprenorphine-Naloxone Medication Assisted Treatment Adherence

Not Applicable

Completed

• Conditions: Opioid-use Disorder
• Interventions: Behavioral: Contingency Management; Behavioral: Brief Motivational Interviewing + Substance Free Activities + Mindfulness

• Registration Number: NCT04080180
• Lead Sponsor: Karen Derefinko, PhD

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-08-16
• Study First Submitted QC: 2019-09-03
• Study First Posted: 2019-09-06
• Study Start: 2022-02-01
• Status Verified: 2025-02
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 332

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

Exclusion Criteria

• Under 18 years old
• Unable to understand spoken English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Contingency Management (CM)	Contingency Management	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.
Brief Motivational Interviewing + Substance Free Activities + Mindfulness (BSM)	Brief Motivational Interviewing + Substance Free Activities + Mindfulness	Participants will receive the BSM intervention at 4 timepoints.
BSM+CM	Contingency Management	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.
BSM+CM	Brief Motivational Interviewing + Substance Free Activities + Mindfulness	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.

Primary Outcome Measures

Name	Time	Method
Medication-Assisted Treatment (MAT) Adherence	through study completion, an average of 8 months	Number of visits where participant attends physician appointment and drug screen results are buprenorphine-positive.

Trial Locations

Locations (1)

University of Tennessee Health Science Center; 🇺🇸 Memphis, Tennessee, United States