What side effects are associated with this type of intervention?

Common treatments for Opioid Use Disorder (OUD) include buprenorphine, methadone, and naltrexone. Buprenorphine can cause side effects such as constipation, nausea, vomiting, sedation, and potential dental issues when taken sublingually. Methadone's side effects include respiratory depression, constipation, sweating, and potential for QT prolongation. Naltrexone may cause nausea, headache, dizziness, and liver enzyme abnormalities. Digital interventions, like the imFREE trial, generally have high acceptability but may face challenges related to user engagement and technology access.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Opioid Use Disorder (OUD), including methadone, buprenorphine, and naltrexone. Buprenorphine, in particular, is a partial opioid agonist that helps reduce withdrawal symptoms and cravings, making it a key component in many OUD treatment programs. The imFREE trial focuses on a digital intervention to improve treatment retention and adherence in conjunction with buprenorphine, aligning with the FDA's approval of buprenorphine for OUD. This approach is designed to enhance the effectiveness of buprenorphine by providing additional support through digital means.

What other types of research exist?

Promising alternatives to imFREE for OUD patients include: 1) Mobile apps like reSET-O, which is FDA-approved and provides cognitive behavioral therapy (CBT) to improve retention and adherence in conjunction with buprenorphine treatment. 2) Internet-based guided self-help programs that follow CBT principles and offer therapist support via email or messaging. 3) Proactive telephone counseling, which has shown efficacy in increasing treatment adherence and retention. 4) Text messaging interventions that provide automated motivational messages and real-time support to manage cravings and adherence.

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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

No Placebo-Only Group

Summary

This study is evaluating whether a mobile app can help people with opioid use disorder stay on treatment.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 3, month 6

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

DSM-V Checklist

Other study objectives

European Addiction Severity Index

Medical Management (MM) attendance

Urine drug screen

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 3Eligibility criteria met

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.