Opioid Use Clinical Trial
— POLYOfficial title:
Treating Polysubstance Use in Methadone Maintenance: Application of Novel Digital Technology
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.
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 |
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 |
Lead Sponsor | Collaborator |
---|---|
Friends Research Institute, Inc. | National Institute on Drug Abuse (NIDA) |
United States,
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 |
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