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OpenTrials
Completed

NCT Number: NCT04808479

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

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.

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Key information

Conditions

Opioid-use Disorder Chemically-Induced Disorders Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tarzana Treatment Center

Tarzana, California, 91356, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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).

Treatment and study plan

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.

Other names: imFREE

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.

Other names: Manualized Health Psychoeducation

Primary outcomes

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

    Time frame: 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 outcomes

  1. DSM-V Checklist

    Time frame: Baseline

    Assessing the presence of opiate use disorder

Other outcomes

  1. European Addiction Severity Index

    Time frame: Baseline, month 3, month 6

    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.

  2. Urine drug screen

    Time frame: Throughout six months, monthly

    Confirming absence/presence of opiates and buprenorphine

  3. Medical Management (MM) attendance

    Time frame: Throughout six months, monthly

    Retention in buprenorphine treatment my reviewing number of MM sessions attended

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • University of California, San Diego

Registry information

Official study 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

Acronym: UCimFREE

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Mar 22, 2021
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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