Testing the Effects of Contingency Management and Behavioral Economics on Buprenorphine-Naloxone Treatment Adherence Using a Sequential Multiple Assignment Randomized Trial (SMART) Design
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 332
- Locations
- 2
- Primary Endpoint
- Medication-Assisted Treatment (MAT) Adherence
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Medication-Assisted Treatment (MAT) Adherence
Time Frame: through study completion, an average of 8 months
Number of visits where participant attends physician appointment and drug screen results are buprenorphine-positive.
Secondary Outcomes
No secondary outcomes reported
Investigators
Karen Derefinko, PhD
Assistant Professor
University of Tennessee