SMART Trial for Buprenorphine-Naloxone Medication Assisted Treatment Adherence
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- 200
Summary
- Conditions
- Opioid Use Disorder
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Sequential AssignmentIntervention Model Description: In stage 1, participants are individually randomized (1:1) to BMI+SFAS 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.Masking: Single (Outcomes Assessor)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
Our research team seeks to compare the effectiveness of these two different interventions for MAT adherence by first refining and piloting CM and BMI+SFAS adherence approaches, then conducting a Sequential Multiple Assignment Randomized Trial (SMART) to assess sequential, individual, and combined ef...
Our research team seeks to compare the effectiveness of these two different interventions for MAT adherence by first refining and piloting CM and BMI+SFAS 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, we propose the following sequential multiple assignment randomized trial (SMART): In stage 1, participants are individually randomized (1:1) to BMI+SFAS 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.
Tracking Information
- NCT #
- NCT04080180
- Collaborators
- University of Memphis
- University of New Mexico
- University of Tennessee
- National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Not Provided
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