SMART Effectiveness Trial

NCT04464421 | Completed Results DMC

• 1 other identifier: 20-07418-XP UM
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The current study piloted two psychosocial interventions developed to increase buprenorphine-naloxone adherence in individuals with opioid use disorder (OUD). Participants were randomized to receive either contingency management (CM) or a brief substance free activities session plus mindfulness (BSM) cognitive-behavioral intervention. Participants were 48 newly presenting patients from an OUD treatment clinic. The primary outcome was medication adherence, as measured by buprenorphine metabolite in urine and presence at 2 or more of 4 possible physician visits.

Conditions

Opioid-use Disorder; Opioid Dependence; Treatment Adherence

Keywords

opioid use disorder; OUD; buprenorphine; treatment adherence; substance-free activities; brief motivational interviewing; contingency management

Outcome Measures

Primary Outcomes (1)

• Treatment Adherence

  Defined as no negative buprenorphine urine tests and attendance of at least two visits.

  Through study completion, an average of 4 months

Study Arms (2)

Contingency management (CM)

EXPERIMENTAL

Participants received incentives for urine toxicology with a positive result for Buprenorphine metabolites at each of the first four visits after initiation of Buprenorphine-Naloxone.

Behavioral: Contingency Management (CM)

BSM

EXPERIMENTAL

BSM (Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion) participants had one-on-one behavioral intervention sessions at each of the first four visits after initiation of Buprenorphine-Naloxone.

Behavioral: Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM)

Interventions

Contingency Management (CM) BEHAVIORAL

Participants were able to draw a gift card from a virtual fishbowl when their urine toxicology results are positive for buprenorphine metabolites. Gift card values were $25, $50, or $100.

Contingency management (CM)

Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM) BEHAVIORAL

Participants had one-on-one sessions with a behavioral interventionist to discuss their goals regarding treatment, how to reach these goals, the importance of substance-free activities, and mindfulness skills.

BSM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older
• Willing to be randomized to one of the two intervention arms
• Ability to comprehend consent and intervention materials (approximately 8th-grade level).

Sponsors & Collaborators

• Karen Derefinko, PhD: lead
• University of Memphis: collaborator
• University of New Mexico: collaborator

Study Sites (1)

University of Tennessee Health Science Center

Memphis, Tennessee, 38163, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Results Point of Contact

• Title: Karen Derefinko, PhD
• Organization: University of Tennessee Health Science Center

kderefin@uthsc.edu

9014482526

Study Officials

• Karen J Derefinko, PhD

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 9, 2020
• Study Start: August 17, 2020
• Primary Completion: July 30, 2021
• Study Completion: August 29, 2021
• Last Updated: December 5, 2025
• Results First Posted: September 10, 2022

Record last verified: 2025-11

Locations

US (1)