SMART Trial Efficacy Study

Pilot Test of Contingency Management and Brief Motivational Interviewing + Substance Free Activity Session Interventions + Mindfulness-Based Adherence Promotion

The purpose of this study is to evaluate the efficacy of two different interventions for medication-assisted treatment (MAT) adherence: Contingency Management (CM) and Brief Motivational Intervention plus Substance Free Activities Session plus Mindfulness-Based Adherence Promotion (BMI+SFAS+MBAP). If the interventions are efficacious, they will be used in a larger trial with a SMART (Sequential Multiple Assignment Randomized Trial) design.

Study Overview

• Status: Completed
• Conditions: Opioid Dependence; Treatment Adherence; Opioid-use Disorder
• Intervention / Treatment: Behavioral: Contingency Management (CM); Behavioral: Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM)

Detailed Description

We will engage with referred OUD patients at the time of their initial visit to the CAS. Interested patients will be informed about the study in a private room, and if eligible, will be consented and randomized to condition. Randomization will occur in blocks of 4. At the next physician visit, participants will engage in their first treatment activities (either payment of $25 for buprenorphine positive/illicit opioid negative saliva screen for those in CM, or their first BMI+SFAS with an Interventionist). This will be repeated for the following 3 weeks.

CM. Those randomized to the CM intervention will receive $25 gift certificates to Amazon for each of the illicit opioid-negative, buprenorphine-positive saliva screens obtained at physician visits. During the pilot trial, 4 clean saliva screens (one each week) will result in a $100 bonus.

BMI+SFAS. Those randomized to the BMI+SFAS will engage in a weekly discussion of several areas known to reduce delay discounting and improve decision-making. Topic areas include: Short and Long-Term Goals: identifying goals (e.g., What are your goals for this month…for the next 5 years? What would you like to have accomplished?), requirements needed to achieve these goals (e.g., What would you need to do to achieve those goals?) and the potential role of illicit opioid use in jeopardizing these goals; Reward Bundling: aggregate global day-to-day choices and activities into cumulative, cohesive patterns that relate to personally relevant long-term health or social outcomes.86,87 A behavior with immediate but low reward value (i.e., taking a daily dose of buprenorphine-naloxone) in the short-term may have higher reward value when it is framed as part of a pattern of achieving a valued long-term outcome (i.e., steady employment at a desired job); Episodic Future Thinking88,89: An experiential intervention that prompts individuals to describe personal, emotional, and situational details of a valued future outcome in great detail (e.g., what it would be like to regain family trust or get a career-job); Substance Free Activities: 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. This weekly intervention will take 30 minutes.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • University of Tennessee Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Present for an intake appointment at study site for treatment of opioid use disorder.
• Eligible for receipt of buprenorphine-naloxone treatment (e.g. Suboxone, Bunavil, Zubsolv) as determined by clinic physicians
• 18 years or older
• Access to a telephone
• Ability to comprehend consent and intervention materials (approximately 8th-grade level).

Exclusion Criteria:

• Physician expects that patient will not follow standard treatment visit schedule

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Contingency management (CM); Participants will receive physical rewards urine toxicology results are positive for buprenorphine (i.e., they are adherent to Medication-Assisted Treatment (MAT)) during their first four visits after initiation of MAT.	Behavioral: Contingency Management (CM); Participants will be able to draw a gift card from a fishbowl when their urine toxicology results are positive for buprenorphine (i.e., they are adherent to Medication-Assisted Treatment). Gift cards in the bowl for drawing will be $25, $50, or $100.
Experimental: BSM; BSM (Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion) participants will have one-on-one behavioral intervention sessions at each of the first four visits after initiation of MAT.	Behavioral: Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM); Participants will have one-on-one sessions with a behavioral interventionist to discuss their goals regarding treatment, how to reach these goals, and the importance of substance-free activities.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Who Were Adherent to Treatment	Defined as no negative buprenorphine urine tests and attendance of at least two visits.	through study completion, an average of 4 months

Collaborators and Investigators

• Sponsor: Karen Derefinko, PhD
• Collaborators: University of New Mexico; University of Memphis
• Investigators: Principal Investigator: Karen J Derefinko, PhD, University of Tennessee

Study record dates

Study Major Dates

• Study Start (Actual): August 17, 2020
• Primary Completion (Actual): July 31, 2021
• Study Completion (Actual): July 31, 2021

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: July 6, 2020
• First Posted (Actual): July 9, 2020

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: buprenorphine; opioid use disorder; treatment adherence; OUD; contingency management; substance-free activities; brief motivational interviewing
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders
• Other Study ID Numbers: 20-07418-XP UM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No