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

Opioid-use Disorder Clinical Trial

— UCimFREE  

Official title:

FOA Title: HEAL Initiative: Behavioral Research to Improve MAT: Behavioral and Social Interventions to Improve Adherence to Medication-Assisted Treatment for Opioid Use Disorders (R61/R33 Clinical Trial Optional

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04808479
• Other study ID #: UC imFREE phase1&RCT
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: August 31, 2026

Study information

• Verified date: May 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: August 31, 2026
• Est. primary completion date: August 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Opioid-Related Disorders
• Opioid-use Disorder

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
United States	Tarzana Treatment Center	Tarzana	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	European Addiction Severity Index	The Addiction Severity Index is a relatively brief, semi-structured interview designed to provide important information about aspects of a client's life that may contribute to his/her substance abuse syndrome.Assessment of addiction severity and frequency of alcohol/drug use.	Baseline, month 3, month 6
Other	Urine drug screen	Confirming absence/presence of opiates and buprenorphine	Throughout six months, monthly
Other	Medical Management (MM) attendance	Retention in buprenorphine treatment my reviewing number of MM sessions attended	Throughout six months, monthly
Primary	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	DSM-V Checklist	Assessing the presence of opiate use disorder	Baseline