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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which of two treatments better helps people adhere to their medication for opioid use disorder. It compares Contingency Management, which uses rewards like gift cards for attending appointments, with a combination of Brief Motivational Interviewing, Substance-Free Activities, and Mindfulness. Some participants may receive a mix of both approaches. This trial is designed for individuals with opioid use disorder who can receive specific medication (buprenorphine-naloxone) and have access to a phone. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance treatment strategies for opioid use disorder.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Contingency Management (CM) effectively supports individuals with opioid use disorder. Studies indicate it is both effective and safe, with participants typically experiencing few side effects. CM rewards patients, often with gift cards, for adhering to their treatment plans, such as attending doctor visits or taking medication.

For the Brief Motivational Interviewing + Substance-Free Activities + Mindfulness (BSM) approach, research suggests these methods can help some individuals reduce substance use. Mindfulness, in particular, has shown promise in reducing cravings. However, evidence is mixed, indicating that some individuals might benefit more than others.

Overall, these treatments are generally well-tolerated. Most studies report minimal side effects, making them safe options for those seeking to improve medication adherence and reduce substance use. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for opioid use disorder because they offer innovative approaches beyond the usual medication-assisted therapies like methadone, buprenorphine, or naltrexone. The Brief Motivational Interviewing + Substance Free Activities + Mindfulness (BSM) intervention is unique because it combines motivational interviewing with structured activities and mindfulness practices, potentially enhancing patient engagement and reducing cravings. Contingency Management (CM) introduces a behavioral twist by rewarding patients with gift cards for attending appointments and adhering to medication, which can boost motivation and adherence. The BSM+CM combination could be particularly effective as it merges these psychological and behavioral strategies, offering a comprehensive approach to treatment. Researchers are hopeful that these interventions can provide additional tools to support recovery and improve outcomes for individuals with opioid use disorder.

What evidence suggests that this trial's treatments could be effective for opioid use disorder?

Studies have shown that Contingency Management (CM), a treatment in this trial, effectively reduces substance use. It uses rewards like gift cards to encourage adherence to treatment, and research indicates it can significantly decrease drug use. Another treatment option in this trial is Brief Motivational Interviewing combined with Substance-Free Activities and Mindfulness (BSM), which also shows promise. This approach helps individuals follow their treatment plans and can lower drug use. Some studies suggest that adding mindfulness can reduce cravings for opioids. Overall, research supports both CM and BSM in assisting individuals with Opioid Use Disorder (OUD). ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8453131/

A Randomized Controlled Trial Protocol - PMC Although ED-based brief motivational interventions delivered by counselors of varying training backgrounds reduce other substance use/consequences among AYAs10 ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0376871625000377

A randomized pilot trial of two forms of behavioral ... This pilot study examined the short-term preliminary effectiveness and satisfaction data on two forms of buprenorphine-naloxone treatment ...

3. case.edu case.edu/socialwork/centerforebp/sites/default/files/2024-09/MI%20and%20MET%20for%20Opioid%20Use%20Disorders%20Research%20Summary%20Report.pdf

MI and MET for Opioid Use Disorders ... Studies with Mixed Results. Five studies yielded mixed but promising results on the effectiveness of motivational interventions for reducing opioid use. In ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2829421

Mindfulness Training vs Recovery Support for Opioid Use, ... Mindfulness was not superior at reducing illicit opioid use compared with an active group intervention with an evidence-based curriculum.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8939890/

Motivational interviewing for substance abuse - PMC The results show that people who have received MI have reduced their use of substances more than people who have not received any treatment. However, it seems ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10061866/

Use of a sequential multiple assignment randomized trial to ... Murphy and colleagues developed a brief intervention called the substance-free activity session (SFAS) which uses a motivational interviewing approach to target ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10714668/

Motivational interviewing for substance use reduction - PMC The results show that motivational interviewing may make little to no difference to substance use compared with regular treatment or another active intervention ...

8. researchgate.net researchgate.net/publication/369623188_Use_of_a_sequential_multiple_assignment_randomized_trial_to_test_contingency_management_and_an_integrated_behavioral_economic_and_mindfulness_intervention_for_buprenorphine-naloxone_medication_adheren

Use of a sequential multiple assignment randomized trial to ... stance-free reward will reduce substance use [23]. Murphy and colleagues developed a brief intervention. called the substance-free activity ...

9. psycnet.apa.org psycnet.apa.org/manuscript/2021-38648-001.pdf

Brief Motivational Interviewing–Based Interventions for Opioid ... Empirical evidence supports the efficacy of combining medication for opioid misuse with psychosocial treatment (e.g., motivational interviewing (MI) strategies, ...