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SMART Trial for Buprenorphine-Naloxone Medication Assisted Treatment Adherence

Primary Purpose

Opioid-use Disorder

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Contingency Management
Brief Motivational Interviewing + Substance Free Activities + Mindfulness
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, buprenorphine, treatment adherence

Eligibility Criteria

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

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

Sites / Locations

  • University of Tennessee Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Contingency Management (CM)

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

BSM+CM

Arm Description

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.

Participants will receive the BSM intervention at 4 timepoints.

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.

Outcomes

Primary Outcome Measures

Medication-Assisted Treatment (MAT) Adherence
Number of visits where participant attends physician appointment and drug screen results are buprenorphine-positive.

Secondary Outcome Measures

Full Information

First Posted
August 16, 2019
Last Updated
January 6, 2023
Sponsor
Karen Derefinko, PhD
Collaborators
University of Memphis, University of New Mexico, University of Tennessee, National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04080180
Brief Title
SMART Trial for Buprenorphine-Naloxone Medication Assisted Treatment Adherence
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

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, University of Tennessee, National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

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

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid-use Disorder
Keywords
opioid use disorder, buprenorphine, treatment adherence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Contingency Management (CM)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Brief Motivational Interviewing + Substance Free Activities + Mindfulness (BSM)
Arm Type
Active Comparator
Arm Description
Participants will receive the BSM intervention at 4 timepoints.
Arm Title
BSM+CM
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Contingency Management
Other Intervention Name(s)
CM
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brief Motivational Interviewing + Substance Free Activities + Mindfulness
Other Intervention Name(s)
BSM
Intervention Description
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.
Primary Outcome Measure Information:
Title
Medication-Assisted Treatment (MAT) Adherence
Description
Number of visits where participant attends physician appointment and drug screen results are buprenorphine-positive.
Time Frame
through study completion, an average of 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Yes
IPD Sharing Plan Description
It is anticipated that a cleaned data set of study-specific data will be provided within two years following the completion of the study for the data archive and this data set would be made public. Confidentiality of individual participants would be maintained with all releases of data. The final study analytical database would be processed according to HIPAA definitions for public data sharing. Documentation would be provided along with the data sharing file that includes but is not limited to: data dictionary, data codebook, valid variable ranges (where provided), the protocol, procedure and operational manuals, intervention manual or programs and any electronic versions of any paper forms that were used in data collection.
IPD Sharing Time Frame
Within two years of study completion.

Learn more about this trial

SMART Trial for Buprenorphine-Naloxone Medication Assisted Treatment Adherence

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