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Opioid Agonist
Digital Rewards App for Opioid and Cocaine Use Disorder (POLY Trial)
Phase 3
Recruiting
Led By Shannon Mitchell, Ph.D.
Research Sponsored by Friends Research Institute, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 48 weeks
Awards & highlights
POLY Trial Summary
This trial tests if an app providing rewards for not using opioids/cocaine can improve outcomes while in methadone treatment.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since this trial involves a digital app rather than medication, traditional side effects are not expected. However, participants may experience stress or frustration related to technology use or privacy concerns regarding drug test submissions.
POLY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 48 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Retention in Methadone Treatment through 48 Weeks
Secondary outcome measures
Changes in Quality of Life through 48 Weeks
Drug Use through 48 Weeks
POLY Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DynamiCare Plus Methadone Treatment-as-UsualExperimental Treatment2 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-UsualActive Control1 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.
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Who is running the clinical trial?
Friends Research Institute, Inc.Lead Sponsor
52 Previous Clinical Trials
20,368 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,470 Previous Clinical Trials
2,619,491 Total Patients Enrolled
Shannon Mitchell, Ph.D.Principal InvestigatorFriends Research Institute, Inc.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: DynamiCare Plus Methadone Treatment-as-Usual
- Group 2: Methadone Treatment-as-Usual
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research program currently receiving participants?
"The clinical trial in question, which initially appeared on March 1st of 2023 and was most recently updated on the 9th of that same month, is no longer accepting patients. Nevertheless, 1291 other medical studies are currently enrolling participants."
Answered by AI
Who else is applying?
What state do they live in?
California
What site did they apply to?
Friends Research Institute, Inc. Central Office
Friends Research Institute, Inc. Office Building
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
2
Why did patients apply to this trial?
Would like to se results. just to see if something else could possible help me or others.
PatientReceived no prior treatments
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