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SMART Trial Efficacy Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04464421
Recruitment Status : Completed
First Posted : July 9, 2020
Results First Posted : September 10, 2022
Last Update Posted : October 6, 2022
Sponsor:
Collaborators:
University of Memphis
University of New Mexico
Information provided by (Responsible Party):
Karen Derefinko, PhD, University of Tennessee

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.

Condition or disease Intervention/treatment Phase
Opioid-use Disorder Opioid Dependence Treatment Adherence Behavioral: Contingency Management (CM) Behavioral: Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Test of Contingency Management and Brief Motivational Interviewing + Substance Free Activity Session Interventions + Mindfulness-Based Adherence Promotion
Actual Study Start Date : August 17, 2020
Actual Primary Completion Date : July 31, 2021
Actual Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine


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.




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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04464421


Locations
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United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38163
Sponsors and Collaborators
Karen Derefinko, PhD
University of Memphis
University of New Mexico
Investigators
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Principal Investigator: Karen J Derefinko, PhD University of Tennessee Health Science Center
  Study Documents (Full-Text)

Documents provided by Karen Derefinko, PhD, University of Tennessee:
Study Protocol  [PDF] June 14, 2021
Statistical Analysis Plan  [PDF] October 19, 2019
Informed Consent Form  [PDF] December 16, 2020

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Responsible Party: Karen Derefinko, PhD, Assistant Professor, University of Tennessee
ClinicalTrials.gov Identifier: NCT04464421    
Other Study ID Numbers: 20-07418-XP UM
First Posted: July 9, 2020    Key Record Dates
Results First Posted: September 10, 2022
Last Update Posted: October 6, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Karen Derefinko, PhD, University of Tennessee:
opioid use disorder
OUD
buprenorphine
treatment adherence
substance-free activities
brief motivational interviewing
contingency management
Additional relevant MeSH terms:
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Opioid-Related Disorders
Narcotic-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders