SMART Trial for Buprenorphine-Naloxone Medication Assisted Treatment Adherence

Karen Derefinko, PhD

Status

Completed

Conditions

Opioid-use Disorder

Treatments

Behavioral: Brief Motivational Interviewing + Substance Free Activities + Mindfulness

Behavioral: Contingency Management

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT04080180

19-06690-FB

1R61AT010604-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment

332 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

Single Blind

332 participants in 3 patient groups

Contingency Management (CM)

Active Comparator group

Description:

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.

Treatment:

Behavioral: Contingency Management

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

Active Comparator group

Description:

Participants will receive the BSM intervention at 4 timepoints.

Treatment:

Behavioral: Brief Motivational Interviewing + Substance Free Activities + Mindfulness

BSM+CM

Active Comparator group

Description:

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.