Effectiveness of a CBT-based mHealth Intervention Targeting MOUD Retention, Adherence, and Opioid Use

Not Applicable

• Conditions: Opioid-use Disorder
• Interventions: Behavioral: imFREE mCBT; Behavioral: mHealth ED

• Registration Number: NCT04808479
• Lead Sponsor: University of California, Los Angeles

Brief Summary

The focus of this study is to examine the effectiveness of imFREE relative to mHealth ED in facilitating treatment retention and adherence and reducing opioid use among adults with OUD initiating BUP treatment.

There are two specific aims: (1) to test the effectiveness of imFREE, delivered in conjunction with medical management with buprenorphine (imFREE + MM), relative to mHealth ED + MM, in facilitating buprenorphine treatment retention and adherence in a population of individuals with OUD initiating MM (N=200). (2) To evaluate the cost-effectiveness of imFREE.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-10
• Study First Submitted: 2021-02-08
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-22
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-13
• Last Update Posted: 2024-05-14
• Primary Completion: 2025-08-01
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age > 18
• DSM-5 diagnosis of OUD
• no more than 2 weeks from the date of BUP induction
• able to read and comprehend English at the 6th grade level (determined by REALM)
• able to provide informed consent
• presently owns a mobile phone that can send and receive text messages

EXCLUSION CRITERIA

Participants must not have:

1. Life threatening or unstable medical illness requiring treatment or making participation difficult
2. Dependence on alcohol or other illicit substances for which medical detoxification is imminently needed
3. Presence of acute psychiatric symptoms warranting intensive treatment or hospitalization (e.g., acute suicidality or mania).

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
UC imFREE Smartphone application intervention	imFREE mCBT	The imFREE condition is a 32-week tailored, interactive text messaging intervention targeting buprenorphine treatment retention and adherence as well as opioid use and associated health consequences. Following a face-to-face CBT session with a clinician, participants receive CBT skills training via daily text messaging, with content themes around relapse prevention, adherence behaviors, and personalized plans to overcome risk factors for treatment discontinuation.
Health Education and pamphlet	mHealth ED	The mHealth condition will provide participants with a manualized health psychoeducation session of equivalent duration to the face-to-face CBT session delivered to imFREE participants. Content focuses on various dimensions of health and well-being. Subsequent to this session participants will receive an informational pamphlet regarding BUP and the importance of adherence. the mHealth component of the intervention comprises text reminders for scheduled MM appointments.

Primary Outcome Measures

Name	Time	Method
Medication Adherence self-report form. Unannounced medication count by phone	Monthly from date of randomization, for up to 6 months, or until study completion, whichever comes first.	Self-report of Treatment adherence to buprenorphine collected in self-report forms. Unannounced medication count by phone. Research staff will call participants and ask them to count out the remaining buprenorphine films left in their prescription.

Secondary Outcome Measures

Name	Time	Method
DSM-V Checklist	Baseline	Assessing the presence of opiate use disorder

Trial Locations

Locations (1)

Tarzana Treatment Center; 🇺🇸 Tarzana, California, United States