search
Back to results

Treating Polysubstance Use Using a Novel Digital Technology (POLY)

Primary Purpose

Opioid Use, Opioid Use Disorder, Cocaine Use

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
DynamiCare Health
Methadone Treatment-As-Usual
Sponsored by
Friends Research Institute, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use focused on measuring methadone, telehealth, mHealth, medications for opioid use disorder (MOUD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Friends Research Institute, Inc. Office Building
  • Friends Research Institute, Inc. Central OfficeRecruiting
  • Glenwood Life Counseling CenterRecruiting
  • Institutes for Behavior ResourcesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Methadone Treatment-as-Usual

DynamiCare Plus Methadone Treatment-as-Usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 24, 2023
Last Updated
September 20, 2023
Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)
search

1. Study Identification

Unique Protocol Identification Number
NCT05766631
Brief Title
Treating Polysubstance Use Using a Novel Digital Technology
Acronym
POLY
Official Title
Treating Polysubstance Use in Methadone Maintenance: Application of Novel Digital Technology
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2023 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
September 29, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Friends Research Institute, Inc.
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use, Opioid Use Disorder, Cocaine Use, Cocaine Use Disorder
Keywords
methadone, telehealth, mHealth, medications for opioid use disorder (MOUD)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Methadone Treatment-as-Usual
Arm Type
Active Comparator
Arm Description
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.
Arm Title
DynamiCare Plus Methadone Treatment-as-Usual
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
DynamiCare Health
Other Intervention Name(s)
DCH
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Methadone Treatment-As-Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
Retention in Methadone Treatment through 48 Weeks
Description
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.
Time Frame
48 weeks
Secondary Outcome Measure Information:
Title
Drug Use through 48 Weeks
Description
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.
Time Frame
48 weeks
Title
Changes in Quality of Life through 48 Weeks
Description
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.
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 or older Cocaine use (self-reported in the past 30 days) Willing and able to provide informed consent Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shannon G Mitchell, Ph.D.
Phone
410-837-3977
Ext
238
Email
smitchell@friendsresearch.org
First Name & Middle Initial & Last Name or Official Title & Degree
Jesse B Fletcher, Ph.D.
Phone
661-373-0782
Email
jfletcher@friendsresearch.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shannon Mitchell, Ph.D.
Organizational Affiliation
Friends Research Institute, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Friends Research Institute, Inc. Office Building
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesse B Fletcher, Ph.D.
Phone
661-373-0782
Email
jfletcher@friendsresearch.org
First Name & Middle Initial & Last Name & Degree
Jesse B Fletcher, Ph.D.
Facility Name
Friends Research Institute, Inc. Central Office
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shannon G Mitchell, Ph.D.
Phone
410-837-3977
Ext
238
Email
smitchell@friendsresearch.org
First Name & Middle Initial & Last Name & Degree
Jan Gryczynski, Ph.D.
Phone
443-676-4219
Email
jgryczynski@friendsresearch.org
Facility Name
Glenwood Life Counseling Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lillian Donnard
Phone
410-323-9811
Ext
201
Email
ldonnard@glenwoodlife.org
Facility Name
Institutes for Behavior Resources
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vickie Walters, LCSW-C
Phone
410-752-6080
Ext
115
Email
vwalters@ibrinc.org

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Treating Polysubstance Use Using a Novel Digital Technology

We'll reach out to this number within 24 hrs