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

NCT04808479 | Active Not Recruiting DMC

• 1 other identifier: UC imFREE phase1&RCT
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

• Medication Adherence self-report form. Unannounced medication count by phone

  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.

  Monthly from date of randomization, for up to 6 months, or until study completion, whichever comes first.

Secondary Outcomes (1)

• DSM-V Checklist

  Baseline

Other Outcomes (3)

• European Addiction Severity Index

  Baseline, month 3, month 6

• Urine drug screen

  Throughout six months, monthly

• Medical Management (MM) attendance

  Throughout six months, monthly

Study Arms (2)

UC imFREE Smartphone application intervention

EXPERIMENTAL

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.

Behavioral: imFREE mCBT

Health Education and pamphlet

ACTIVE COMPARATOR

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.

Behavioral: mHealth ED

Interventions

imFREE mCBT BEHAVIORAL

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.

Also known as: imFREE

UC imFREE Smartphone application intervention

mHealth ED BEHAVIORAL

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.

Also known as: Manualized Health Psychoeducation

Health Education and pamphlet

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• Participants must not have:
• Life threatening or unstable medical illness requiring treatment or making participation difficult
• Dependence on alcohol or other illicit substances for which medical detoxification is imminently needed
• Presence of acute psychiatric symptoms warranting intensive treatment or hospitalization (e.g., acute suicidality or mania).

Sponsors & Collaborators

• University of California, Los Angeles: lead
• University of California, San Diego: collaborator

Study Sites (1)

Tarzana Treatment Center

Tarzana, California, 91356, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

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

Study Officials

• Suzette Glasner, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2021
• First Posted: March 22, 2021
• Study Start: December 10, 2019
• Primary Completion: May 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Locations

US (1)