Digital Rewards App for Opioid and Cocaine Use Disorder

(POLY Trial)

Recruiting at 5 trial locations

Overseen By Karen Alexander, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Friends Research Institute, Inc.

Must be taking: Methadone

Disqualifiers: Severe psychiatric disorders, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 48 weeks

240 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an app designed to help people reduce opioid and cocaine use while continuing methadone treatment. Researchers aim to determine if the app helps people remain in treatment longer and use drugs less, ultimately enhancing their quality of life. Participants will either continue with regular methadone treatment or use the app alongside their treatment. The app enables remote drug testing and rewards users with money for staying drug-free and attending treatment activities. Individuals who have used cocaine in the last 30 days and can use a smartphone might be suitable for this trial. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, since the study involves methadone treatment, you may need to continue with it if you are already on it.

What prior data suggests that this app is safe for use in treating opioid and cocaine use disorder?

Research shows that people using the DynamiCare Health app generally feel satisfied with their treatment. Some studies also found that users stayed in treatment longer and avoided drug use more effectively. This suggests that most people find the app easy to use. Although specific side effects weren't mentioned, the continued use and reported benefits suggest it is safe. As this trial is in a late stage, evidence already indicates its safety for humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Rewards App for Opioid and Cocaine Use Disorder because it adds a digital twist to traditional methadone treatment. Unlike standard care, which typically involves in-person counseling and medication, this app empowers patients with remote tools for managing their recovery. Participants use a smartphone app to complete random drug screenings, track appointments, and access helpful modules, making treatment more accessible and interactive. The app also incentivizes progress with a Next Step debit card, offering a fresh approach to engage patients in their recovery journey. By integrating technology with traditional treatment, this innovative method aims to enhance patient participation and outcomes.

What evidence suggests that this app is effective for reducing opioid and cocaine use?

Research has shown that the DynamiCare Health app, which participants in this trial may use alongside Methadone Treatment-as-Usual, can help reduce the use of drugs like opioids and cocaine. One study found that 66% of participants using the app with their regular treatment achieved better results. The app rewards users for staying drug-free, encouraging adherence to their treatment. Users have also reported greater satisfaction with their treatment and more success in remaining drug-free. This method shows promise for those seeking to improve their quality of life while managing substance use issues. ^{2 3 4 6 7}

Who Is on the Research Team?

Karen Alexander, Ph.D.

Principal Investigator

Friends Research Institute, Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 18 who have used cocaine recently and are currently on methadone treatment. They must be able to understand the study and agree to participate. People under home detention, with restricted phone access, severe psychiatric disorders, or visual impairments that prevent app use cannot join.

Inclusion Criteria

Willing and able to provide informed consent

Cocaine use (self-reported in the past 30 days)

Exclusion Criteria

Severe psychiatric disorders

On home detention

Living arrangement that currently restricts phone access

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive methadone treatment as usual, with or without the DynamiCare app, for 48 weeks

48 weeks

Regular visits for methadone treatment and app-based activities

Follow-up

Participants are monitored for retention in methadone treatment and changes in drug use and quality of life

12 months

Follow-up assessments at 3, 6, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• DynamiCare Health
• Methadone Treatment-As-Usual

Trial Overview The study tests if an app can help people using opioids and cocaine stay in methadone treatment longer and reduce drug use compared to usual treatment alone. Participants will either continue regular methadone treatments or also use a special app that rewards them for staying clean and following their treatment plan.

How Is the Trial Designed?

Group I: DynamiCare Plus Methadone Treatment-as-Usual Experimental Treatment 2 Interventions

DynamiCare Plus Methadone Treatment-as-Usual (DCM+TAU) participants will receive the same services as TAU participants, plus access to the DynamiCare Health smartphone app for 48 weeks. After randomization, the research assistant (RA) will download the DynamiCare Health app onto their smart phone (or provide them with a smartphone with the app already installed). Participants will get oral fluid testing kits and a Next Step debit card. Participants will be trained in use of the app and oral fluid test kits and will practice until they can produce two valid tests in a row without aid of the research staff. Participants will earn $40 for successful completion of the orientation and training. DCM+TAU participants will then use the app to complete remote random drug screenings, prove attendance to appointments and medication pickups, interact with modules designed to improve substance use reductions, and other treatment-related activities.

Group II: Methadone Treatment-as-Usual Active Control 1 Intervention

Participants randomized to the Methadone Treatment-as-Usual (TAU) Condition will receive treatment-as-usual at the community methadone clinics, which will include daily medication, individual and group addiction counseling, and outpatient or intensive outpatient behavioral health services, depending on the clinic and the needs of the patient. After randomization into the TAU arm, participants will complete the program's psychosocial and medical intake, methadone dose induction and adjustment, and provide urine tests and receive medication take-homes per the program's policies and methadone treatment regulations.

Methadone Treatment-As-Usual is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Methadone hydrochloride for:

• Opioid Use Disorder (OUD)
• Pain management

Approved in European Union as Methadone hydrochloride for:

• Opioid dependence
• Severe pain

Approved in Canada as Methadone hydrochloride for:

• Opioid dependence
• Chronic pain

Who Is Running the Clinical Trial?

Friends Research Institute, Inc.

Lead Sponsor

Trials

60

Recruited

22,500+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Published Research Related to This Trial

In a study involving 206 participants, adding LETS ACT to standard intensive outpatient treatment for substance use disorder significantly reduced substance use days for up to 6 months post-treatment, compared to treatment as usual.

The inclusion of a smartphone app did not enhance treatment outcomes, suggesting that the effectiveness of LETS ACT may not rely on digital tools and that more than six sessions of behavioral activation could be beneficial for sustained recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group behavioral activation with and without a smartphone app in intensive outpatient treatment for substance use disorder: A three-arm randomized controlled trial. Paquette, CE., Reese, ED., Yi, JY., et al.[2023]

An 8-week all-virtual program for treating methamphetamine use disorder (MUD) was effective, with participants showing increased likelihood of testing negative for meth use over the course of the treatment (OR = 1.57).

The program, which included counseling, therapeutic tasks, and medical oversight, was well-received, with 55% of participants completing it and 16 out of 27 reporting no meth use one month after finishing the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Demonstration of an app-delivered digital therapeutic program for methamphetamine use disorder. Muhlner, K., DeFlavio, J., Ang, A., et al.[2023]

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 Internet can significantly enhance addiction treatment by enabling efficient delivery of educational content and secure collection of self-reported data on substance use, making treatment more accessible and effective.

Internet applications support various aspects of addiction treatment, including assessment, monitoring patient outcomes, ongoing recovery support, and training for treatment providers, ultimately improving the quality of care and patient engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

How Internet technology can improve the quality of care for substance use disorders. Cucciare, MA., Weingardt, KR., Humphreys, K.[2019]

A pilot study involving 58 adults in a Vermont opioid treatment program demonstrated that a video directly observed therapy (VDOT) app combined with a secure medication dispenser led to 98.4% compliance in medication ingestion, with only a minimal rate of noncompliance.

Participants experienced significant reductions in travel time and costs (86% reduction), saving a median of $72 weekly and 5.5 hours of travel time, while maintaining a high retention rate of 98% in treatment after 12 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characterizing the Clinical use of a Novel Video-assisted Dosing Protocol With Secure Medication Dispensers to Reduce Barriers to Opioid Treatment. Brooklyn, JR., Stothart, M., Stunell, M., et al.[2022]

The pilot study involving 80 participants showed that the body motion-activated video game, Recovery Warrior 2.0, is feasible and acceptable for use in inpatient addiction treatment settings, with participants engaging in an average of 36.6 minutes of gameplay over multiple days.

While the game did not significantly reduce drug use overall, it showed a positive effect on marijuana addiction at the 4-week follow-up, suggesting potential benefits for specific substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Motion-Activated Video Game for Prevention of Substance Use Disorder Relapse in Youth: Pilot Randomized Controlled Trial. Abroms, LC., Fishman, M., Vo, H., et al.[2020]

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 integrated smartphone-smartcard platform significantly improved counseling appointment attendance and drug abstinence rates among 85 adults with opioid use disorder over a four-month period, showing a 9.6%-18.0% increase in attendance and an odds ratio of 4.84 for drug abstinence compared to matched controls.

Participants overwhelmingly found the platform acceptable, indicating that this technology could help overcome barriers to the adoption of contingency management (CM) interventions in treatment settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smartphone-smartcard platform for contingency management in an inner-city substance use disorder outpatient program. DeFulio, A., Rzeszutek, MJ., Furgeson, J., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8197772/

Digital delivery of a contingency management intervention ... This study showed that 66% of participants (19/29) randomized to use DynamiCare Health as a supplement to usual care treatment exhibited both ...

2. dynamicarehealth.com dynamicarehealth.com/

DynamiCare Health | Technology for Substance Use Recovery DynamiCare's Digital Recovery Platform delivers proven, scalable solutions to help individuals reduce or eliminate their use of alcohol, drugs, and tobacco.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10390940/

The effectiveness and value of digital health technologies ... The effectiveness and value of digital health technologies as an adjunct to medication-assisted therapy for opioid use disorder.

4. withpower.com withpower.com/trial/phase-disease-2-2023-c3e0a

Digital Rewards App for Opioid and Cocaine Use Disorder Participants using the mobile intervention reported increased treatment satisfaction and showed signs of improved treatment retention and abstinence from ...

5. icer.org icer.org/news-insights/press-releases/icer-publishes-final-evidence-report-and-policy-recommendations-for-digital-health-therapeutics-for-opioid-use-disorder/

ICER Publishes Final Evidence Report and Policy ... DynamiCare (DynamiCare Health), a digital app that includes 36 classroom-based training modules, monitoring for substance abstinence, and debit ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12263680/

Digitally delivered contingency management during ... People in treatment for opioid use disorder (OUD) who also use cocaine are at heightened risk of early treatment discontinuation and poor ...

7. dynamicarehealth.com dynamicarehealth.com/cm-reports

Contingency Management Reports — DynamiCare Health The U.S. drug crisis has reached a critical juncture, with stimulant-related overdose deaths surpassing opioid-related fatalities for the first time in 2022.