Opioid Agonist

DynamiCare Plus Methadone Treatment-as-Usual for Opioid Use Disorder

Glenwood Life Counseling Center, Baltimore, MD
Targeting 4 different conditionsMethadone Treatment-As-Usual +1 morePhase 3RecruitingLed by Shannon Mitchell, Ph.D.Research Sponsored by Friends Research Institute, Inc.

Study Summary

This trial tests if an app providing rewards for not using opioids/cocaine can improve outcomes while in methadone treatment.

Eligible Conditions
  • Opioid Use Disorder
  • Cocaine Use
  • Cocaine Use Disorder


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

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

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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.

Find a site

Who is running the clinical trial?

Friends Research Institute, Inc.Lead Sponsor
50 Previous Clinical Trials
20,035 Total Patients Enrolled
National Institute on Drug Abuse (NIDA)NIH
2,353 Previous Clinical Trials
2,045,094 Total Patients Enrolled
Shannon Mitchell, Ph.D.Principal Investigator
Friends Research Institute, Inc.

Media Library

Methadone Treatment-As-Usual (Opioid Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05766631 — Phase 3
Opioid Use Disorder Research Study Groups: DynamiCare Plus Methadone Treatment-as-Usual, Methadone Treatment-as-Usual
Opioid Use Disorder Clinical Trial 2023: Methadone Treatment-As-Usual Highlights & Side Effects. Trial Name: NCT05766631 — Phase 3
Methadone Treatment-As-Usual (Opioid Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05766631 — Phase 3

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?
What site did they apply to?
Friends Research Institute, Inc. Office Building
What portion of applicants met pre-screening criteria?
Met criteria
~160 spots leftby Jun 2027