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SMART Trial for Buprenorphine-Naloxone Medication Assisted Treatment Adherence

Sponsor
Karen Derefinko, PhD (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04080180
Collaborator
University of Memphis (Other), University of New Mexico (Other), University of Tennessee (Other), National Center for Complementary and Integrative Health (NCCIH) (NIH)
280
Enrollment
1
Location
3
Arms
33
Anticipated Duration (Months)
8.5
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Contingency Management
  • Behavioral: Brief Motivational Interviewing + Substance Free Activities + Mindfulness
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
280 participants
Allocation:
Randomized
Intervention Model:
Sequential Assignment
Intervention Model Description:
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.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.
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Testing the Effects of Contingency Management and Behavioral Economics on Buprenorphine-Naloxone Treatment Adherence Using a Sequential Multiple Assignment Randomized Trial (SMART) Design
Actual Study Start Date :
Feb 1, 2022
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Contingency Management (CM)

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
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

    		•
    Active Comparator: Brief Motivational Interviewing + Substance Free Activities + Mindfulness (BSM)

    Participants will receive the BSM intervention at 4 timepoints.

    Behavioral: Brief Motivational Interviewing + Substance Free Activities + Mindfulness
    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

    		•
    Active Comparator: BSM+CM

    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
    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

    • Behavioral: Brief Motivational Interviewing + Substance Free Activities + Mindfulness
    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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Medication-Assisted Treatment (MAT) Adherence [through study completion, an average of 6 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Tennessee Health Science Center Memphis Tennessee United States 38163

    Sponsors and Collaborators

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

    Investigators

    None specified.

    Study Documents (Full-Text)

    More Information

    Publications

    None provided.
    Responsible Party:
    Karen Derefinko, PhD, Assistant Professor, University of Tennessee
    ClinicalTrials.gov Identifier:
    NCT04080180
    Other Study ID Numbers:
    • 19-06690-FB
    • 1R61AT010604-01
    First Posted:
    Sep 6, 2019
    Last Update Posted:
    Apr 21, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Karen Derefinko, PhD, Assistant Professor, University of Tennessee
    opioid use disorder
    buprenorphine
    treatment adherence
    Additional relevant MeSH terms:
    Opioid-Related Disorders

    Study Results

    No Results Posted as of Apr 21, 2022