Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05766631
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2023-02-24
Brief Title:
Treating Polysubstance Use Using a Novel Digital Technology
Sponsor:
Friends Research Institute Inc
Organization:
Friends Research Institute Inc
Study Overview
Official Title:
Treating Polysubstance Use in Methadone Maintenance Application of Novel Digital Technology
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
POLY
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 andor 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 andor 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 hasnt 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
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 andor 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 andor 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 hasnt 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 TAUDCM 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 TAUDCM compared to TAU alone in improving methadone treatment retention through 12-months post treatment entry
Aim 2 To determine the relative effectiveness of TAUDCM 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
The study will examine participant outcomes in the domains of three aims
Aim 1 To determine the relative effectiveness of TAUDCM compared to TAU alone in improving methadone treatment retention through 12-months post treatment entry
Aim 2 To determine the relative effectiveness of TAUDCM 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01DA057608-01 | NIH | None | httpsreporternihgovquickSearch1R01DA057608-01 |