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Completed

NCT Number: NCT04080180

SMART Trial for Buprenorphine-Naloxone Medication Assisted Treatment Adherence

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).

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Key information

Conditions

Opioid-use Disorder Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: 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.

Other names: BSM

Primary outcomes

  1. Medication-Assisted Treatment (MAT) Adherence

    Time frame: through study completion, an average of 8 months

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

Sponsors and collaborators

Lead sponsor

Karen Derefinko, PhD

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • University of Memphis
  • University of New Mexico
  • University of Tennessee

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 6, 2019
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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