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

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to determine the effects of an app to reduce opioid and cocaine use when layered atop methadone treatment as usual among people using both opioids and cocaine. The main questions it aims to answer are: * Do people who use the app remain in methadone treatment longer than people who receive only treatment as usual? * Do people who use the app report using opioids and/or cocaine less often, and do they report better improvements in their quality of life, than people who receive only treatment as usual? * Does using the app more lead to better methadone treatment outcomes among people using the app? Participants in this study will be randomly assigned to receive either the app or methadone treatment as usual. Participants randomly assigned to the treatment as usual group will receive access to methadone services as normally provided, including scheduled access to medications, information about the consequences of opioid and other drug use, and any onsite services (including group based interventions and/or 12-step programs). Those randomized into the app-using group will receive all the same services as the treatment as usual group, but will also be given a phone with the app already installed, or will have the app installed on their existing phone if they already have one. At random times throughout the week, the app will ask participants to submit drug tests for opioids and cocaine, which participants will be able to do remotely without having to physically "go to" a testing site. For each test that demonstrates the participant hasn't used opioids or cocaine, the participant will be rewarded with money directly into a debit card. Participants will also be able to earn rewards for picking up treatment-related medications, attending onsite appointments, and other treatment-related activities.

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 data supports the effectiveness of this treatment for opioid and cocaine use disorder?

Research shows that using a mobile app alongside methadone treatment can help people stay in treatment longer and reduce drug cravings. Additionally, using smartphone technology for contingency management (reward-based therapy) has been linked to higher rates of drug abstinence and better adherence to treatment. ^{1 2 3 4 5}

Is the Digital Rewards App for Opioid and Cocaine Use Disorder safe for humans?

The studies suggest that digital therapeutic apps, including those used alongside methadone treatment, are generally safe and well-received by participants. They have been found to be feasible, acceptable, and useful in supporting treatment adherence and reducing drug use, with no significant safety concerns reported. ^{1 2 3 6 7}

How is Methadone Treatment-As-Usual different from other treatments for opioid and cocaine use disorder?

Methadone Treatment-As-Usual is unique because it involves a mobile intervention that clients find practical and engaging, helping them manage drug cravings and increasing treatment retention and abstinence compared to standard methadone treatment alone. ^{1 2 3 7 8}

Research Team

Karen Alexander, Ph.D.

Principal Investigator

Friends Research Institute, Inc.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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]

References

1. 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]

2. Netherlands 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. [2022]

3. Ireland 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. [2023]

4. United Arab Emirates pubmed.ncbi.nlm.nih.gov

How Internet technology can improve the quality of care for substance use disorders. [2019]

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

A smartphone-smartcard platform for contingency management in an inner-city substance use disorder outpatient program. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Demonstration of an app-delivered digital therapeutic program for methamphetamine use disorder. [2023]

7. 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]

8. Canada pubmed.ncbi.nlm.nih.gov

A Motion-Activated Video Game for Prevention of Substance Use Disorder Relapse in Youth: Pilot Randomized Controlled Trial. [2020]