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

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the treatment imFREE mCBT, mHealth ED for opioid use disorder?

Research shows that digital therapeutic tools, like mobile apps, can help people understand and engage with treatments for opioid use disorder. Additionally, computer-assisted cognitive behavioral therapy (CBT) has been effective in treating substance dependence, suggesting that similar mobile health apps could be beneficial. ^{1 2 3 4 5}

Is the CBT-Based Mobile Health App for Opioid Use Disorder safe for humans?

The research on similar mobile health apps for opioid use disorder shows they are generally safe, with participants finding them easy to use and helpful. No specific safety concerns were reported in the studies, and participants successfully used the app features without issues. ^{1 5 6 7 8}

How is the CBT-Based Mobile Health App for Opioid Use Disorder different from other treatments?

The CBT-Based Mobile Health App for Opioid Use Disorder is unique because it uses a digital platform to deliver cognitive behavioral therapy (CBT), which can be accessed anytime via a smartphone. This makes it more accessible and potentially more engaging for users compared to traditional in-person therapy sessions. ^{1 2 5 9 10}

Research Team

Suzette Glasner, PhD

Principal Investigator

University of California, Los Angeles

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]

2. Australia pubmed.ncbi.nlm.nih.gov

Clinician-assisted computerised versus therapist-delivered treatment for depressive and addictive disorders: a randomised controlled trial. [2022]

3. England 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. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Enduring effects of a computer-assisted training program for cognitive behavioral therapy: a 6-month follow-up of CBT4CBT. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Delivering information about medication assisted treatment to individuals who misuse opioids through a mobile app: a pilot study. [2021]

6. Netherlands 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. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Efficacy of a Smartphone-Based Contingency Management Intervention for Buprenorphine Adherence. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

A mixed-methods evaluation of the feasibility, acceptability, and preliminary efficacy of a mobile intervention for methadone maintenance clients. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Customized recommendations and reminder text messages for automated, computer-based treatment during methadone. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Digital Help for Substance Users (SU): A Systematic Review. [2023]