Smartphone App for Opioid Use Disorder

Overseen By Noah R Wolkowicz, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Must be taking: Buprenorphine, Methadone

Disqualifiers: Untreated psychiatric disorders, Suicidal ideation, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

65 Participants Needed

Trial Summary

What is the purpose of this trial?

Opioid Use Disorder (OUD) is a complex, chronic condition affecting nearly 70,000 Veterans who can experience significantly reduced quality of life (e.g., poorer social, occupational, and health-related functioning). VA clinics providing Medication treatment for OUD (MOUD; e.g., buprenorphine, methadone), the 1st-line treatment for OUD, often face challenges in also attempting to treat Veteran functional needs, which may require them to extend beyond their available resources to provide support. There is an urgent need for functionally impactful and accessible treatments for Veterans in MOUD. Acceptance and Commitment Therapy (ACT) is a well-suited framework to support the functioning of Veterans in MOUD with over 20 years of research support. However, the traditional practice ACT requires a trained clinician to provide weekly, hour-long therapy sessions (typically for 12-16 weeks) and may be too burdensome for MOUD clinics to use alongside standard care. Fortunately, emerging research suggests that mobile health interventions (MHIs; e.g., smartphone apps) can overcome many of these pragmatic barriers. MHIs can efficiently deliver functionally-focused treatments focused on Veteran functioning in "real-world" settings, through minimally burdensome and accessible formats. Currently however, no MHI's targeting functioning exist for Veterans in MOUD. The proposed study will address this gap by developing and evaluating an early prototype of a targeted smartphone app designed to enhance the functional outcomes of Veterans receiving MOUD called "ACT to RECOVER" (Acceptance and Commitment Therapy to Reach Empowerment through Commitment, Openness, and Valuing Experiences in Recovery). The study will occur in 3 phases: Phase 1: Development. Develop content for ACT to RECOVER using Veteran (n=10) and provider feedback (n=10). Phase 2: Iterative Usability Assessment. Conduct field testing (3 rounds, n=4-5 per round) to refine ACT to RECOVER format, acceptability, and usability. Phase 3: Pilot ACT to RECOVER in a Stage 1b Randomized Controlled Trial (RCT). Conduct a pilot trial to compare ACT to RECOVER (n=20) to a smartphone-based symptom monitoring control group (n=20). * (3a) Evaluate the acceptability and feasibility of each condition's app and study procedures. * (3b) Explore changes in functional (e.g., values-based living, quality of life) and clinical outcomes (e.g., illicit opioid use) which will be key outcomes in future efficacy testing.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. In fact, participants must be actively receiving medication treatment for opioid use disorder, such as buprenorphine or methadone, to be eligible.

What data supports the effectiveness of the treatment ACT to RECOVER for opioid use disorder?

Research shows that digital therapeutic tools, like smartphone apps, can help improve outcomes for people with opioid use disorder by providing additional support alongside medication. For example, the OptiMAT app aims to reduce opioid misuse by offering timely interventions, and the reSET-O app has been shown to help patients stick to their treatment plans. ^{1 2 3 4 5}

Is the smartphone app for opioid use disorder safe for humans?

The smartphone app, evaluated under names like ACT to RECOVER and reSET-O, has been studied in clinical trials and is considered safe for use in humans as part of treatment for opioid use disorder. ^{2 3 4 5 6}

How is the ACT to RECOVER treatment for opioid use disorder different from other treatments?

ACT to RECOVER is unique because it uses a smartphone app to support people with opioid use disorder, providing just-in-time interventions and information to improve outcomes when used alongside traditional medication-assisted treatments like Suboxone. ^{1 4 5 7 8}

Research Team

Noah R Wolkowicz, PhD

Principal Investigator

VA Connecticut Healthcare System West Haven Campus, West Haven, CT

Eligibility Criteria

This trial is for Veterans with Opioid Use Disorder (OUD) who are currently receiving medication treatment. It aims to improve their quality of life and psychosocial functioning through a new smartphone app, 'ACT to RECOVER'.

Inclusion Criteria

Current diagnosis of Opioid Use Disorder (OUD) indicated by either DSM-5-TR or ICD-9 or -10 codes

I am currently on medication for opioid use disorder.

I understand and can sign the consent form.

Exclusion Criteria

Have been on MOUD, in their current treatment episode (i.e., since their most recent induction), for longer than 12 consecutive months prior to their baseline visit

Have any cognitive/medical impairment precluding study participation or use of smartphones/smartphone applications

Have untreated major psychiatric disorders (e.g., bipolar disorders, psychotic disorders)

Timeline

Development

Develop content for ACT to RECOVER using Veteran and provider feedback

15 months

Iterative Usability Assessment

Conduct field testing to refine ACT to RECOVER format, acceptability, and usability

18 months

Pilot RCT

Conduct a pilot trial to compare ACT to RECOVER to a smartphone-based symptom monitoring control group

27 months

Baseline, midpoint, endpoint, and follow-up visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 weeks

Treatment Details

Interventions

• ACT to RECOVER
• Smartphone-based Symptom-Monitoring

Trial Overview The study tests 'ACT to RECOVER', an app based on Acceptance and Commitment Therapy, against standard symptom-monitoring via smartphone. The trial includes developing the app with Veteran feedback, refining it through usability testing, and then comparing outcomes in a pilot randomized controlled trial.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

This Phase 3 (Stage 1b RCT) Arm will consist of n = 20 Veterans (anticipated enrollment) who will receive the prototype ACT to RECOVER smartphone intervention for 4 weeks.

Group II: Control Placebo Group 1 Intervention

This Phase 3 (Stage 1b RCT) Arm will consist of n = 20 Veterans (anticipated enrollment) who will be assigned to receive a smartphone-based symptom-monitoring program for 4 weeks.

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

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 use of reSET-O, a digital therapeutic for patients undergoing buprenorphine medication-assisted treatment for opioid use disorder, led to a significant reduction in healthcare encounters, including 45 fewer inpatient visits and 27 fewer emergency department visits over six months among 351 patients.

Patients also experienced a net cost savings of $2,150 per person, indicating that reSET-O not only improved treatment adherence but also reduced overall healthcare costs associated with opioid use disorder management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic. Velez, FF., Colman, S., Kauffman, L., et al.[2022]

A web-based self-management intervention for chronic pain patients on opioids was developed based on feedback from 53 participants, highlighting the need for additional pain management strategies and the importance of goal setting.

Participants found the web-based tool potentially useful and acceptable, indicating that it effectively increased their knowledge about self-management of chronic pain, suggesting a promising approach for improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. Moore, SK., Guarino, H., Acosta, MC., et al.[2022]

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]

A study is being conducted to evaluate the effectiveness of a smartphone app called OptiMAT as an adjunctive intervention for improving outcomes in medication-assisted treatment (MAT) for opioid use disorder (OUD), specifically targeting individuals in outpatient settings.

The trial will compare two groups: one receiving standard MAT and the other receiving MAT with the OptiMAT app, assessing opioid misuse through urinalysis over a 6-month period, which could lead to better treatment strategies in rural areas heavily affected by the opioid crisis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. Thompson, RG., Bollinger, M., Mancino, MJ., et al.[2023]

A significant increase in Opioid Use Disorder (OUD) diagnoses during pregnancy highlights the need for effective treatment solutions, which this study addresses through feedback from 18 peripartum individuals and 19 obstetric providers.

The development of the Listening to Women and Pregnant and Postpartum People (LTWP) program, informed by qualitative interviews, aims to enhance the implementation of evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) in prenatal care, although initial feedback indicated a lack of enthusiasm for the web-based intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Listening to women and pregnant and postpartum people: Qualitative research to inform opioid use disorder treatment for pregnant and postpartum people. Guille, C., Hall, C., King, C., et al.[2023]

Methadone is the most effective medication for treating opioid use disorder (OUD), as it helps suppress withdrawal symptoms and has strong evidence supporting its efficacy, especially with longer treatment durations leading to better social outcomes.

New formulations of buprenorphine and naltrexone, along with take-home naloxone programs, aim to improve safety and adherence in OUD treatment, addressing issues like relapse and overdose risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medication Treatment of Opioid Use Disorder. Bell, J., Strang, J.[2021]

A study is being conducted to evaluate the effectiveness of the smartphone app OptiMAT as an adjunctive intervention for improving outcomes in medication-assisted treatment (MAT) for opioid use disorder (OUD), particularly among adults in outpatient settings.

The trial will compare opioid misuse rates between participants using OptiMAT alongside their treatment and those receiving standard treatment alone, with results expected to inform future use of the app in rural areas and identify which features of OptiMAT are most beneficial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone intervention to optimize medication assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. Thompson, RG., Bollinger, M., Mancino, M., et al.[2023]

References

1. 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]

2. England pubmed.ncbi.nlm.nih.gov

Real-world reduction in healthcare resource utilization following treatment of opioid use disorder with reSET-O, a novel prescription digital therapeutic. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Patients as collaborators: using focus groups and feedback sessions to develop an interactive, web-based self-management intervention for chronic pain. [2022]

4. 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]

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

Smartphone intervention to optimize medication-assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. [2023]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Listening to women and pregnant and postpartum people: Qualitative research to inform opioid use disorder treatment for pregnant and postpartum people. [2023]

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

Medication Treatment of Opioid Use Disorder. [2021]

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

Smartphone intervention to optimize medication assisted treatment outcomes for opioid use disorder: study protocol for a randomized controlled trial. [2023]