SMART Trial for Buprenorphine-Naloxone Medication Assisted Treatment Adherence

NCT04080180 | Completed

• 2 other identifiers: 19-06690-FB1R61AT010604-01
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Opioid-use Disorder

Keywords

opioid use disorder; buprenorphine; treatment adherence

Outcome Measures

Primary Outcomes (1)

• Medication-Assisted Treatment (MAT) Adherence

  Number of visits where participant attends physician appointment and drug screen results are buprenorphine-positive.

  through study completion, an average of 8 months

Study Arms (3)

Contingency Management (CM)

ACTIVE COMPARATOR

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.

Behavioral: Contingency Management

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

ACTIVE COMPARATOR

Participants will receive the BSM intervention at 4 timepoints.

Behavioral: Brief Motivational Interviewing + Substance Free Activities + Mindfulness

BSM+CM

ACTIVE COMPARATOR

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.

Behavioral: Contingency Management; Behavioral: Brief Motivational Interviewing + Substance Free Activities + Mindfulness

Interventions

Contingency Management BEHAVIORAL

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.

Also known as: CM

BSM+CM; Contingency Management (CM)

Brief Motivational Interviewing + Substance Free Activities + Mindfulness BEHAVIORAL

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.

Also known as: BSM

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Present with symptoms of Opioid Use Disorder
• Eligible of receipt of buprenorphine-naloxone medication as determined by Study Doctor
• Access to a telephone

You may not qualify if:

• Under 18 years old
• Unable to understand spoken English

Sponsors & Collaborators

• Karen Derefinko, PhD: lead
• University of Memphis: collaborator
• University of New Mexico: collaborator
• University of Tennessee: collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

Related Publications (1)

• Peter SC, Murphy JG, Witkiewitz K, Hand SB, Thomas F, Johnson KC, Cowan R, Harris M, Derefinko KJ. Use of a sequential multiple assignment randomized trial to test contingency management and an integrated behavioral economic and mindfulness intervention for buprenorphine-naloxone medication adherence for opioid use disorder. Trials. 2023 Mar 29;24(1):237. doi: 10.1186/s13063-023-07102-9.

  PMID: 36991453 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders; Treatment Adherence and Compliance

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: In stage 1, participants are individually randomized (1:1) to BSM 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.

Study Record Dates

• First Submitted: August 16, 2019
• First Posted: September 6, 2019
• Study Start: February 1, 2022
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Within two years of study completion.

Locations

US (1)