N/A N=48 Randomized Single-blind Treatment

SMART Effectiveness Trial

Opioid-use Disorder · Opioid Dependence · Treatment Adherence

Bottom Line

View on ClinicalTrials.gov: NCT04464421 ↗

Enrolled (actual)

Serious AEs

4.6%

Results posted

Sep 2022

Primary outcome: Primary: Treatment Adherence — 16; 13 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Contingency Management (CM) (Behavioral); Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM) (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Karen Derefinko, PhD
Primary completion: Jul 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Treatment Adherence	16; 13	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04464421). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.