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SMART Trial Efficacy Study

Primary Purpose

Opioid-use Disorder, Opioid Dependence, Treatment Adherence

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency Management (CM)
Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM)
Sponsored by
Karen Derefinko, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid-use Disorder focused on measuring opioid use disorder, OUD, buprenorphine, treatment adherence, substance-free activities, brief motivational interviewing, contingency management

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Tennessee Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Contingency management (CM)

BSM

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of Participants Who Were Adherent to Treatment
Defined as no negative buprenorphine urine tests and attendance of at least two visits.

Secondary Outcome Measures

Full Information

First Posted
June 23, 2020
Last Updated
September 9, 2022
Sponsor
Karen Derefinko, PhD
Collaborators
University of Memphis, University of New Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT04464421
Brief Title
SMART Trial Efficacy Study
Official Title
Pilot Test of Contingency Management and Brief Motivational Interviewing + Substance Free Activity Session Interventions + Mindfulness-Based Adherence Promotion
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
August 17, 2020 (Actual)
Primary Completion Date
July 31, 2021 (Actual)
Study Completion Date
July 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Karen Derefinko, PhD
Collaborators
University of Memphis, University of New Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder, Opioid Dependence, Treatment Adherence
Keywords
opioid use disorder, OUD, buprenorphine, treatment adherence, substance-free activities, brief motivational interviewing, contingency management

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Contingency management (CM)
Arm Type
Experimental
Arm Description
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.
Arm Title
BSM
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management (CM)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of Participants Who Were Adherent to Treatment
Description
Defined as no negative buprenorphine urine tests and attendance of at least two visits.
Time Frame
through study completion, an average of 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen J Derefinko, PhD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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