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Behavioral Intervention

CBT-Based Mobile Health App for Opioid Use Disorder (UCimFREE Trial)

N/A
Waitlist Available
Led By Suzette Glasner, PhD
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age > 18
Be older than 18 years old
Must not have
Life threatening or unstable medical illness requiring treatment or making participation difficult
Presence of acute psychiatric symptoms warranting intensive treatment or hospitalization (e.g., acute suicidality or mania).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout six months, monthly
Awards & highlights

Summary

This trial will help to determine if imFREE, a new app, is more effective than mHealth ED, another app, in helping people with opioid use disorders (OUD) stay on their buprenorphine treatment and reducing opioid use.

Who is the study for?
Adults over 18 with Opioid Use Disorder (OUD) who have started buprenorphine treatment within the last two weeks can join. Participants must own a mobile phone capable of texting and be able to understand English at a 6th-grade level. Those with alcohol or other substance dependencies needing detox, severe medical illnesses, or acute psychiatric symptoms like suicidality are excluded.Check my eligibility
What is being tested?
The trial is testing imFREE, a cognitive-behavioral therapy-based mobile health intervention, against mHealth ED for its effectiveness in keeping patients on buprenorphine treatment and reducing opioid use among adults with OUD. It also assesses the cost-effectiveness of imFREE.See study design
What are the potential side effects?
Since this trial focuses on behavioral interventions through mobile health technology rather than medications, traditional side effects are not applicable. However, participants may experience discomfort or stress related to engagement with the content.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have any severe illnesses that would make joining a study hard.
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I do not have severe mental health issues requiring urgent care.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 3, month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 3, month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Medication Adherence self-report form. Unannounced medication count by phone
Secondary outcome measures
DSM-V Checklist
Other outcome measures
European Addiction Severity Index
Medical Management (MM) attendance
Urine drug screen

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: UC imFREE Smartphone application interventionExperimental Treatment1 Intervention
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.
Group II: Health Education and pamphletActive Control1 Intervention
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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Opioid Use Disorder include medications such as buprenorphine, methadone, and naltrexone. Buprenorphine is a partial opioid agonist that reduces cravings and withdrawal symptoms by activating opioid receptors in the brain to a lesser degree than full agonists like heroin. Methadone is a full opioid agonist that also reduces cravings and withdrawal symptoms but with a longer duration of action, helping to stabilize patients. Naltrexone is an opioid antagonist that blocks the effects of opioids, preventing the euphoric and sedative effects. These treatments are crucial for OUD patients as they help manage withdrawal symptoms, reduce cravings, and prevent relapse, thereby improving treatment retention and adherence. Digital interventions like imFREE can further support these treatments by providing continuous engagement and support, enhancing overall treatment outcomes.

Find a Location

Who is running the clinical trial?

University of California, San DiegoOTHER
1,135 Previous Clinical Trials
1,551,044 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,541 Previous Clinical Trials
10,266,843 Total Patients Enrolled
Suzette Glasner, PhDPrincipal InvestigatorUniversity of California, Los Angeles
4 Previous Clinical Trials
172 Total Patients Enrolled

Media Library

imFREE mCBT (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04808479 — N/A
Opioid Use Disorder Research Study Groups: UC imFREE Smartphone application intervention, Health Education and pamphlet
Opioid Use Disorder Clinical Trial 2023: imFREE mCBT Highlights & Side Effects. Trial Name: NCT04808479 — N/A
imFREE mCBT (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04808479 — N/A
~36 spots leftby Aug 2025