NCT04080180

SMART Trial for Buprenorphine-Naloxone Medication Assisted Treatment Adherence

Testing the Effects of Contingency Management and Behavioral Economics on Buprenorphine-Naloxone Treatment Adherence Using a Sequential Multiple Assignment Randomized Trial (SMART) Design

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 332 (actual)
• Sponsor: Karen Derefinko, PhD · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Opioid-use Disorder

Interventions

Type	Name	Description
BEHAVIORAL	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.
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.

Timeline

• Start date: 2022-02-01
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2019-09-06
• Last updated: 2025-02-25

Locations

1 site across 1 country: United States