Treating Polysubstance Use Using a Novel Digital Technology

Opioid Use Clinical Trial

— POLY  

Official title:

Treating Polysubstance Use in Methadone Maintenance: Application of Novel Digital Technology

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766631
• Other study ID #: 11387
• Secondary ID: 1R01DA057608-01
• Status: Recruiting
• Phase: Phase 3
• Start date: July 26, 2023
• Est. completion date: September 29, 2027

Study information

• Verified date: September 2023
• Source: Friends Research Institute, Inc.
• Contact: Shannon G Mitchell, Ph.D.
• Phone: 410-837-3977
• Email: smitchell[@]friendsresearch.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This two-arm randomized trial will evaluate the impact of 48 weeks of the DynamiCare app-based CM (DCM) intervention on retention in methadone treatment and polysubstance use among 240 methadone maintenance (OTP) patients with comorbid opioid use disorder and cocaine use disorder. New enrollees in methadone maintenance at two community treatment programs will be randomly assigned to either methadone treatment-as-usual (TAU) at the OTP or methadone TAU paired with the DynamiCare Health app (TAU+DCM) including remote drug testing and monetary rewards for negative opioid and cocaine tests indicating abstinence. Data on methadone treatment retention will be obtained through OTP records, and follow-up assessments will be conducted at 3-, 6-, and 12-months post-enrollment.

The study will examine participant outcomes in the domains of three aims:

Aim 1: To determine the relative effectiveness of TAU+DCM compared to TAU alone in improving methadone treatment retention through 12-months post treatment entry.

Aim 2: To determine the relative effectiveness of TAU+DCM compared to TAU alone in terms of [AIM 2a] reducing opioid use and cocaine use; and [Aim 2b] improving other secondary outcomes including non-targeted substance use and quality of life through 12-months post treatment entry.

Aim 3: To explore app use patterns, acceptability, and perceived value of personalized content on opioid and polysubstance use through 12-months post treatment entry.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: September 29, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 or older

2. Cocaine use (self-reported in the past 30 days)

3. Willing and able to provide informed consent

Exclusion Criteria:

1. Severe psychiatric disorders

2. On home detention

3. Visual impairment that would make the use of the phone app impractical

4. Living arrangement that currently restricts phone access

Related Conditions & MeSH terms

• Cocaine Use
• Cocaine Use Disorder
• Opioid Use
• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Behavioral:
• DynamiCare Health
Participants earn incentives for: CM for opioid and cocaine abstinence. Accomplished via oral fluid (saliva) test kits given to participants. 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). 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. 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.

Drug:
• Methadone Treatment-As-Usual
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.

Locations

Country	Name	City	State
United States	Friends Research Institute, Inc. Central Office	Baltimore	Maryland
United States	Glenwood Life Counseling Center	Baltimore	Maryland
United States	Institutes for Behavior Resources	Baltimore	Maryland
United States	Friends Research Institute, Inc. Office Building	Cerritos	California

Sponsors (2)

Lead Sponsor	Collaborator
Friends Research Institute, Inc.	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Drug Use through 48 Weeks	Self-reported data, clinical records, urinalysis at baseline and 3-/6-/12-month follow-ups, as well as random drug testing associated with the DynamiCare app will all be used in concert to determine opioid, cocaine, and other drug use during the 48-week intervention period.	48 weeks
Secondary	Changes in Quality of Life through 48 Weeks	Self-report data collected at baseline as well as at the 3-/6-/12-month follow-up assessments will assess changes in participants quality of life, including familial, legal, and/or medical issues, during the 48-week intervention period.	48 weeks