Clinical trial NCT05766631: Treating Polysubstance Use Using a Novel Digital Technology
Official title: Treating Polysubstance Use in Methadone Maintenance: Application of Novel Digital Technology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Opioid Use
Opioid Use Disorder
Cocaine Use
Cocaine Use Disorder
Keywords: methadone
telehealth
mHealth
medications for opioid use disorder (MOUD)
Lead sponsor: Friends Research Institute, Inc.
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2023-03-13
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Retention in Methadone Treatment through 48 Weeks
timeFrame: 48 weeks
Secondary outcomes:
measure: Drug Use through 48 Weeks
timeFrame: 48 weeks
measure: Changes in Quality of Life through 48 Weeks
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Friends Research Institute, Inc. Central Office
state: Maryland
city: Baltimore
country: United States
facility: Glenwood Life Counseling Center
state: Maryland
city: Baltimore
country: United States
facility: Institutes for Behavior Resources
state: Maryland
city: Baltimore
country: United States
facility: Man Alive
state: Maryland
city: Baltimore
country: United States
facility: BD Health Services, Inc. -- Dundalk
state: Maryland
Study officials:
affiliation: Friends Research Institute, Inc.
name: Karen Alexander, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: