Treating Polysubstance Use Using a Novel Digital Technology

NCT05766631 | Recruiting Phase 3 DMC

• 2 other identifiers: 113871R01DA057608-01
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Opioid Use; Opioid Use Disorder; Cocaine Use; Cocaine Use Disorder

Keywords

methadone; telehealth; mHealth; medications for opioid use disorder (MOUD)

Outcome Measures

Primary Outcomes (1)

• Retention in Methadone Treatment through 48 Weeks

  The primary outcome of the proposed study is retention in methadone treatment, which will be determined via clinic attendance records, and will be defined as 7 days of continuous absence from scheduled clinic medication visits at any point during the 48-week intervention period.

  48 weeks

Secondary Outcomes (2)

• Drug Use through 48 Weeks

  48 weeks

• Changes in Quality of Life through 48 Weeks

  48 weeks

Study Arms (2)

Methadone Treatment-as-Usual

ACTIVE COMPARATOR

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.

Drug: Methadone Treatment-As-Usual

DynamiCare Plus Methadone Treatment-as-Usual

EXPERIMENTAL

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.

Behavioral: DynamiCare Health; Drug: Methadone Treatment-As-Usual

Interventions

DynamiCare Health BEHAVIORAL

Participants earn incentives for: 1. CM for opioid and cocaine abstinence. Accomplished via oral fluid (saliva) test kits given to participants. 2. Patients who test negative on opioids and cocaine are also eligible for a bonus if they additionally test negative for non-targeted drugs (except methadone). 3. Patients will receive notices of their medication pickup appointments through the app itself, and monetary rewards will be delivered to the Next Step debit card when the participant's presence at the clinic is verified by clinic records. 4. The app provides 72 self-administered modules based on the principles of cognitive behavioral therapy that are designed to aid in relapse prevention; small incentive rewards ($1) are provided for completion of up to 3 modules per week for the first weeks of treatment.

Also known as: DCH

DynamiCare Plus Methadone Treatment-as-Usual

Methadone Treatment-As-Usual DRUG

Participants will receive treatment-as-usual at the methadone clinic, including daily methadone dosing, individual and group addiction counseling, and OP or IOP behavioral health services, depending on the clinic and the needs of the patient.

DynamiCare Plus Methadone Treatment-as-Usual; Methadone Treatment-as-Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older
• Cocaine use (self-reported in the past 30 days)
• Willing and able to provide informed consent

You may not qualify if:

• Severe psychiatric disorders
• On home detention
• Visual impairment that would make the use of the phone app impractical
• Living arrangement that currently restricts phone access

Sponsors & Collaborators

• Friends Research Institute, Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (5)

Friends Research Institute, Inc. Central Office

Baltimore, Maryland, 21201, United States

RECRUITING

Glenwood Life Counseling Center

Baltimore, Maryland, 21212, United States

RECRUITING

Institutes for Behavior Resources

Baltimore, Maryland, 21218, United States

RECRUITING

Man Alive

Baltimore, Maryland, 21218, United States

RECRUITING

BD Health Services, Inc. -- Dundalk

Baltimore, Maryland, 21222, United States

RECRUITING

Related Publications (1)

• Alexander K, Sharma A, Fletcher JB, Smith Z, Huddleston T, Gryczynski J, Stitzer M. Digitally delivered contingency management during methadone treatment for people with co-occurring cocaine and opioid use: a protocol for a randomized controlled trial. Front Psychiatry. 2025 Jul 2;16:1576277. doi: 10.3389/fpsyt.2025.1576277. eCollection 2025.

  PMID: 40673228 DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Karen Alexander, Ph.D.

  Friends Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karen Alexander, Ph.D.

CONTACT

267-398-3560; kalexander@friendsresearch.org

Jesse B Fletcher, Ph.D.

CONTACT

661-373-0782; jfletcher@friendsresearch.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-arm, parallel random assignment (covariate-adaptive allocation to ensure equal distribution of three variables across groups: age, gender, recent cocaine use) with assessments at baseline, as well as 3-/6-/12-months post randomization.

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 13, 2023
• Study Start: July 26, 2023
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 29, 2027
• Last Updated: December 15, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (5)