SMART Interventions for Opioid Use Disorder

Overseen By Sarah Hand, MPH, CCRP

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Karen Derefinko, PhD

Must be taking: Buprenorphine-naloxone

Disqualifiers: Under 18, Non-English speakers

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 8 months

332 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

This trial is for adults with Opioid Use Disorder who are eligible to receive buprenorphine-naloxone medication, as determined by the study doctor. Participants must have access to a telephone and be able to understand spoken English.

Inclusion Criteria

Access to a telephone

The study doctor has approved me for buprenorphine-naloxone treatment.

You have signs of being addicted to opioids.

Exclusion Criteria

Unable to understand spoken English

I am younger than 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either Contingency Management (CM) or Brief Motivational Interviewing + Substance Free Activities + Mindfulness (BSM) for medication-assisted treatment adherence

8 months

4 visits (in-person) for CM, 4 timepoints for BSM

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Brief Motivational Intervention plus Substance Free Activities Session
• Brief Motivational Interviewing + Substance Free Activities + Mindfulness
• Contingency Management

Trial Overview The SMART Trial is testing two interventions aimed at improving adherence to medication-assisted treatment: Contingency Management (CM), which rewards patients for meeting certain goals, and a combination of Brief Motivational Interviewing + Substance Free Activities + Mindfulness (BSM).

Participant Groups

Group I: Contingency Management (CM) Active Control 1 Intervention

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.

Group II: Brief Motivational Interviewing + Substance Free Activities + Mindfulness (BSM) Active Control 1 Intervention

Participants will receive the BSM intervention at 4 timepoints.

Group III: BSM+CM Active Control 2 Interventions

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.

Who Is Running the Clinical Trial?

Karen Derefinko, PhD

Lead Sponsor

Trials

4

Recruited

700+

University of Memphis

Collaborator

Trials

73

Recruited

12,000+

University of New Mexico

Collaborator

Trials

393

Recruited

3,526,000+

University of Tennessee

Collaborator

Trials

202

Recruited

146,000+

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Trials

886

Recruited

677,000+