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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up throughout six months, monthly
Awards & highlights
UCimFREE Trial 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.
UCimFREE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
UCimFREE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, month 3, month 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 3, month 6
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
UCimFREE 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.
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Who is running the clinical trial?
University of California, San DiegoOTHER
1,120 Previous Clinical Trials
1,521,207 Total Patients Enrolled
University of California, Los AngelesLead Sponsor
1,528 Previous Clinical Trials
10,276,651 Total Patients Enrolled
Suzette Glasner, PhDPrincipal InvestigatorUniversity of California, Los Angeles
4 Previous Clinical Trials
172 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have been diagnosed with opioid use disorder (OUD) according to the DSM-5 guidelines.You have a mobile phone that is capable of sending and receiving text messages.You have an addiction to drugs or alcohol that requires immediate medical treatment.You are able to read and comprehend English at the 6th grade level.I do not have any severe illnesses that would make joining a study hard.I am older than 18 years.I do not have severe mental health issues requiring urgent care.
Research Study Groups:
This trial has the following groups:- Group 1: UC imFREE Smartphone application intervention
- Group 2: Health Education and pamphlet
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is it still possible for people to participate in this research project?
"The clinical trial in question, as indicated by clinicaltrials.gov, is not presently looking for new patients to enrol. This study was first posted on December 10th, 2019 and was last edited on April 22nd, 2022. Although this trial is not enrolling at the moment, there 547 other studies that are."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Tarzana Treatment Center
What portion of applicants met pre-screening criteria?
Met criteria
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