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SMART Effectiveness Trial

NCT04464421 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 48

Last updated 2025-12-05

Study results available
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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

Interventions

BEHAVIORAL

Contingency Management (CM)

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.

BEHAVIORAL

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

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.

Sponsors & Collaborators

  • University of Memphis

    collaborator OTHER

  • University of New Mexico

    collaborator OTHER

  • Karen Derefinko, PhD

    lead OTHER

Principal Investigators

  • Karen J Derefinko, PhD · University of Tennessee

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-17
Primary Completion
2021-07-30
Completion
2021-08-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04464421 on ClinicalTrials.gov