240 Participants Needed

Digital Rewards App for Opioid and Cocaine Use Disorder

(POLY Trial)

Recruiting at 5 trial locations
SG
JB
KA
Overseen ByKaren Alexander, Ph.D.
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Friends Research Institute, Inc.
Must be taking: Methadone
No Placebo GroupAll 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 DataThis treatment has passed at least one previous human trial
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

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.12345

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.12356

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.12378

Who Is on the Research Team?

KA

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
See 1 more

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?
2Treatment groups
Experimental Treatment
Active Control
Group I: DynamiCare Plus Methadone Treatment-as-UsualExperimental Treatment2 Interventions
Group II: Methadone Treatment-as-UsualActive Control1 Intervention

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:
🇪🇺
Approved in European Union as Methadone hydrochloride for:
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Approved in Canada as Methadone hydrochloride for:

Find a Clinic Near You

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

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.
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.
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.
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]

Citations

A mixed-methods evaluation of the feasibility, acceptability, and preliminary efficacy of a mobile intervention for methadone maintenance clients. [2023]
Characterizing the Clinical use of a Novel Video-assisted Dosing Protocol With Secure Medication Dispensers to Reduce Barriers to Opioid Treatment. [2022]
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 Emiratespubmed.ncbi.nlm.nih.gov
How Internet technology can improve the quality of care for substance use disorders. [2019]
A smartphone-smartcard platform for contingency management in an inner-city substance use disorder outpatient program. [2021]
Demonstration of an app-delivered digital therapeutic program for methamphetamine use disorder. [2023]
Safety and efficacy of a prescription digital therapeutic as an adjunct to buprenorphine for treatment of opioid use disorder. [2022]
A Motion-Activated Video Game for Prevention of Substance Use Disorder Relapse in Youth: Pilot Randomized Controlled Trial. [2020]
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