CBT-Based Mobile Health App for Opioid Use Disorder

(UCimFREE Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Los Angeles

Must be taking: Buprenorphine

Disqualifiers: Unstable illness, Alcohol dependence, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 32 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app called imFREE to assist individuals with opioid use disorder (OUD) in adhering to their buprenorphine (BUP) treatment. Participants receive daily text messages with cognitive behavioral therapy (CBT) skills to prevent relapse and improve treatment adherence. The trial compares this method to standard health education and reminders (mHealth ED). Suitable candidates for this study are adults who have recently started BUP treatment, have OUD, and can use a mobile phone for texts. As an unphased trial, this study provides a unique opportunity to explore innovative ways to support recovery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study involves starting buprenorphine treatment, it's best to discuss your current medications with the trial team to ensure there are no interactions.

What prior data suggests that this CBT-based mobile health app is safe for individuals with opioid use disorder?

Research has shown that the imFREE mobile app for cognitive behavioral therapy (mCBT) builds on a successful text message program. It uses text messages to help individuals adhere to their medication and prevent relapse. Studies have found this approach effectively supports people with opioid use disorder. Regarding safety, using a mobile app for CBT is generally well-received. It is non-invasive, meaning it involves no physical procedures or changes to medication. So far, no negative effects from using the app itself have been reported.

Prospective participants in a trial with imFREE can feel confident that it focuses on providing support and skills through their phone to help them stay on track with their treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the imFREE mCBT treatment for opioid use disorder because it offers a fresh approach by integrating technology with cognitive-behavioral therapy (CBT). Unlike traditional methods that rely heavily on in-person counseling and medication like methadone or buprenorphine, imFREE delivers CBT skills training through interactive daily text messages. This method not only supports relapse prevention and treatment adherence but also provides personalized plans to tackle risk factors using a convenient mobile platform. This tech-savvy approach has the potential to enhance engagement and retention in treatment programs, offering a modern twist to managing opioid use disorder.

What evidence suggests that this CBT-based mobile health app is effective for opioid use disorder?

Research has shown that the imFREE app, one of the interventions in this trial, helps individuals with opioid use disorder (OUD) adhere to their buprenorphine (BUP) treatment. Participants in this trial who use the imFREE app will receive daily text messages with tips on avoiding relapse and maintaining focus, reinforcing skills from an initial in-person session. The app aims to reduce opioid use by addressing risk factors and promoting healthy habits. Overall, imFREE seeks to keep individuals engaged in their treatment and effectively reduce opioid use. ^{1 5 6 7 8}

Who Is on the Research Team?

Suzette Glasner, PhD

Principal Investigator

University of California, Los Angeles

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

You have been diagnosed with opioid use disorder (OUD) according to the DSM-5 guidelines.

no more than 2 weeks from the date of BUP induction

You have a mobile phone that is capable of sending and receiving text messages.

Exclusion Criteria

You have an addiction to drugs or alcohol that requires immediate medical treatment.

I do not have any severe illnesses that would make joining a study hard.

I do not have severe mental health issues requiring urgent care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the imFREE intervention, a 32-week tailored, interactive text messaging intervention targeting buprenorphine treatment retention and adherence.

32 weeks

1 face-to-face CBT session, daily text messaging

Follow-up

Participants are monitored for safety and effectiveness after treatment, including monthly self-reports and unannounced medication counts.

6 months

Monthly phone calls

What Are the Treatments Tested in This Trial?

Interventions

• imFREE mCBT
• mHealth ED

Trial Overview 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.

How Is the Trial Designed?

Group I: UC imFREE Smartphone application intervention Experimental Treatment 1 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 pamphlet Active Control 1 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.

Who Is Running the Clinical Trial?

University of California, Los Angeles

Lead Sponsor

Trials

1,594

Recruited

10,430,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

Published Research Related to This Trial

In a study of 274 participants with depression and substance use issues, integrated cognitive behavior therapy and motivational interviewing (CBT/MI) delivered by computer with brief therapist assistance (CAC) showed equal or better effectiveness in reducing alcohol consumption compared to traditional therapist-delivered CBT/MI.

Supportive counseling (person-centered therapy) was less effective in reducing depression and alcohol use compared to both computer-assisted and therapist-delivered CBT/MI, highlighting the importance of structured therapeutic approaches for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician-assisted computerised versus therapist-delivered treatment for depressive and addictive disorders: a randomised controlled trial. Kay-Lambkin, FJ., Baker, AL., Kelly, B., et al.[2022]

In a study of 97 participants with comorbid depression and substance misuse, intensive motivational interviewing and cognitive behavior therapy (MI/CBT) significantly improved depression symptoms compared to a brief intervention alone, with both live and computer-based formats showing effectiveness at the 12-month follow-up.

Computer-based therapy for depression and substance use was found to be at least as effective as live therapy, particularly in reducing cannabis use and hazardous substance use, suggesting that integrated computer-based interventions could be a viable option in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-based psychological treatment for comorbid depression and problematic alcohol and/or cannabis use: a randomized controlled trial of clinical efficacy. Kay-Lambkin, FJ., Baker, AL., Lewin, TJ., et al.[2022]

A pilot study involving 26 adults with opioid use disorder (OUD) showed that using the mobile app 'uMAT-R' significantly increased interest in treatment from 32% to 48%.

Participants also reported improved attitudes towards medication-assisted treatment (MAT), with 88% believing the app would be helpful in making recovery decisions, indicating its potential as a supportive tool in addressing the opioid epidemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. Cavazos-Rehg, PA., Krauss, MJ., Costello, SJ., et al.[2021]

A pilot study involving 25 new clients in methadone maintenance treatment (MMT) found that a mobile psychosocial intervention was feasible and highly acceptable, with participants rating it positively on usability and usefulness.

Participants using the mobile intervention reported increased treatment satisfaction and showed signs of improved treatment retention and abstinence from illicit opioids over a 3-month period compared to those receiving standard MMT, indicating its potential to enhance treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mixed-methods evaluation of the feasibility, acceptability, and preliminary efficacy of a mobile intervention for methadone maintenance clients. Guarino, H., Acosta, M., Marsch, LA., et al.[2023]

The Recovery Line, a computer-based intervention using cognitive behavioral therapy, showed promise in assisting patients on methadone maintenance, but actual usage was lower than recommended, highlighting the need for improved patient engagement strategies.

In two randomized trials involving 127 participants, customized recommendations improved usability ratings, and shorter reminder message latencies initially increased call frequency, particularly among males, suggesting that tailored approaches can enhance engagement with digital health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Customized recommendations and reminder text messages for automated, computer-based treatment during methadone. Moore, BA., Buono, FD., Printz, DMB., et al.[2021]

In a study of 170 adults with opioid use disorder, those receiving a digital therapeutic alongside standard treatment had significantly higher rates of opioid abstinence (77.3% vs. 62.1%) during the final weeks of treatment.

The digital therapeutic also improved treatment retention, with participants less likely to leave treatment compared to those receiving standard care alone, while showing no increase in adverse events, indicating it is a safe and effective addition to traditional therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. Maricich, YA., Bickel, WK., Marsch, LA., et al.[2022]

The MySafeRx mobile platform, which integrates motivational coaching and adherence monitoring for buprenorphine/naloxone treatment, was found to be usable and acceptable among participants, with a high mean usability score of 78.4 and positive feedback on its features.

Despite the positive reception, the study faced challenges in recruitment and did not show significant differences in outcomes between the MySafeRx group and the standard care control group, indicating that while the platform is promising, its impact on adherence and treatment success may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the feasibility, usability and acceptability of the MySafeRx platform among individuals in outpatient buprenorphine treatment: Lessons learned from a pilot randomized controlled trial. Janzow, GE., Harding, C., Flores, M., et al.[2023]

A study involving 20 participants over 12 weeks demonstrated that smartphone-based contingency management effectively promoted adherence to buprenorphine treatment, achieving a 76% confirmed adherence rate.

All participants remained in treatment throughout the study, and they reported high satisfaction with the app, indicating that this approach could be a practical solution for improving medication adherence in opioid use disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Efficacy of a Smartphone-Based Contingency Management Intervention for Buprenorphine Adherence. DeFulio, A., Brown, HD., Davidson, RM., et al.[2023]

A study involving 73 individuals with substance dependence showed that those who received computer-assisted cognitive behavioral therapy (CBT4CBT) maintained lower drug use over a 6-month follow-up compared to those receiving standard treatment.

The positive effects of CBT4CBT were durable, indicating that this computer-based therapy can provide lasting benefits in reducing substance use even after treatment has ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enduring effects of a computer-assisted training program for cognitive behavioral therapy: a 6-month follow-up of CBT4CBT. Carroll, KM., Ball, SA., Martino, S., et al.[2021]

Citations

1. reporter.nih.gov reporter.nih.gov/project-details/10857323

Effectiveness of a CBT-based mHealth Intervention Targeting ... In Phase II, (i) the effectiveness of imFREE in improving BUP treatment retention and adherence and decreasing opioid use is evaluated in an RCT comparing ...

2. withpower.com withpower.com/trial/cbt-based-mobile-health-app-for-opioid-use-disorder-d23af

CBT-Based Mobile Health App for Opioid Use Disorder This study is evaluating whether a mobile app can help people with opioid use disorder stay on treatment.

3. reporter.nih.gov reporter.nih.gov/project-details/9869738

Project Details - NIH RePORTER In Phase II, (i) the effectiveness of imFREE in improving BUP treatment retention and adherence and decreasing opioid use is evaluated in an RCT comparing ...

4. highergov.com highergov.com/grant/R33AT010800/

mHealth Intervention for MOUD Retention & Adherence IMFREE also targets decreased opioid use, with features to notify social and provider support contacts in the face of treatment discontinuation and/or other ...

5. thelancet.com thelancet.com/cms/10.1016/S2215-0366(23)00095-0/attachment/e6f0198f-0a28-4b0f-9aac-75e36b70102e/mmc1.pdf

Supplementary appendix Health Clinics Using Buprenorphine. To examine the effectiveness of opioid use disorder. (OUD) treatment linkage strategies for patients seen at.

6. heal.nih.gov heal.nih.gov/funding/awarded?comb=&rfa=All&research_program=All&institutions1=&locations1=&goal=All&combine=&grant=All&locations=&institutions=&select_location=All&year=&items_per_page=25&page=35&order=field_investigators&sort=desc

Funded Projects | NIH HEAL Initiative imFREE builds upon the efficacious SMS-based TXT-CBT intervention, with content addressing retention and adherence to BUP, including mitigating risk factors for ...

7. heal.nih.gov heal.nih.gov/funding/awarded?advancedSearch=false&combine=overdose&goal=All&grant=All&institutions1=&institutions=&items_per_page=25&locations1=&locations=&order=field_investigators&research_program=All&rfa=All&select_location=All&sort=desc&year=&page=17

Funded Projects | NIH HEAL Initiative imFREE builds upon the efficacious SMS-based TXT-CBT intervention, with content addressing retention and adherence to BUP, including mitigating risk factors for ...

8. aging.networkofcare.org aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT04808479?keyword=%22Opioid%20Use%20Disorder%22

San Mateo Clinical Trial Effectiveness of a CBT-based ... The focus of this study is to examine the effectiveness of imFREE relative to mHealth ED in facilitating treatment retention and adherence and reducing ...