Opioid UsePhase 3POLYNCT05766631
Treating Polysubstance Use Using a Novel Digital Technology
A Phase 3 study testing DynamiCare Health and Methadone Treatment-As-Usual in people with Opioid Use and Opioid Use Disorder, run by Friends Research Institute, Inc. at 5 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Opioid Use Disorder, Cocaine Use
- What is being tested?
- DynamiCare Health and Methadone Treatment-As-Usual
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 5 sitesUnited States
- Study dates
- 26 Jul 2023to 29 Sep 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Cocaine use (self-reported in the past 30 days)
- Willing and able to provide informed consent
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Friends Research Institute, Inc. Central Office
Baltimore, Maryland, 21201
Glenwood Life Counseling Center
Baltimore, Maryland, 21212
Institutes for Behavior Resources
Baltimore, Maryland, 21218
Man Alive
Baltimore, Maryland, 21218
BD Health Services, Inc. -- Dundalk
Baltimore, Maryland, 21222
About this study
Official 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.
Read the 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.
- Conditions
- Opioid Use, Opioid Use Disorder, Cocaine Use, Cocaine Use Disorder
- Being tested
- DynamiCare Health, Methadone Treatment-As-Usual
- Keywords
- methadone, telehealth, mHealth, medications for opioid use disorder (MOUD)
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DynamiCare HealthBehavioural
Also called DCH
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.
Methadone Treatment-As-UsualDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Methadone Treatment-as-Usual | Active comparator | 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. Receives: Drug: Methadone Treatment-As-Usual |
| DynamiCare Plus Methadone Treatment-as-Usual | Experimental | 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. Receives: Behavioral: DynamiCare Health; Drug: Methadone Treatment-As-Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 48 weeks
Secondary outcomes (2)
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.
Measured: 48 weeks
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.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start26 Jul 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion29 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Karen Alexander, Ph.D., Principal investigator, Friends Research Institute, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05766631
- Sponsor's protocol ID
- 11387
- Other IDs
- 1R01DA057608-01
- Acronym
- POLY
- Status last verified
- May 2026
- First submitted
- 24 Feb 2023
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Alexander K, Sharma A, Fletcher JB, Smith Z, Huddleston T, Gryczynski J, Stitzer M. Digitally delivered contingency management during methadone treatment for people with co-occurring cocaine and opioid use: a protocol for a randomized controlled trial. Front Psychiatry. 2025 Jul 2;16:1576277. doi: 10.3389/fpsyt.2025.1576277. eCollection 2025.
PubMed 40673228
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Polysubstance Use in Methadone Maintenance: Application of Novel Digital Technology
- ClinicalTrials.gov ID
- NCT05766631
- Acronym / sponsor ID
- POLY / 11387
- Conditions
- Opioid Use, Opioid Use Disorder, Cocaine Use, Cocaine Use Disorder
- Keywords
- methadone, telehealth, mHealth, medications for opioid use disorder (MOUD)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 29 Sep 2027 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Methadone Treatment-as-Usual | Active comparator | Drug: Methadone Treatment-As-UsualParticipants 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 | Experimental | Behavioral: DynamiCare Health, Drug: Methadone Treatment-As-UsualDynamiCare 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or older
- Cocaine use (self-reported in the past 30 days)
- Willing and able to provide informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DynamiCare HealthAlso: DCHParticipants earn incentives for: 1. CM for opioid and cocaine abstinence. Accomplished via oral fluid (saliva) test kits given to participants. 2. 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). 3. 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. 4. 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. | Behavioural | DynamiCare Plus Methadone Treatment-as-Usual |
| Methadone Treatment-As-UsualParticipants 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. | Drug | DynamiCare Plus Methadone Treatment-as-Usual, Methadone Treatment-as-Usual |
Primary outcome
Retention in Methadone Treatment through 48 Weeks
Time frame: 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.
2 secondary outcomes
Drug Use through 48 Weeks
Time frame: 48 weeks
Changes in Quality of Life through 48 Weeks
Time frame: 48 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
- Derived from this study: PubMed 40673228Alexander K, Sharma A, Fletcher JB, Smith Z, Huddleston T, Gryczynski J, Stitzer M. Digitally delivered contingency management during methadone treatment for people with co-occurring cocaine and opioid use: a protocol for a randomized controlled trial. Front Psychiatry. 2025 Jul 2;16:1576277. doi: 10.3389/fpsyt.2025.1576277. eCollection 2025.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen Alexander, Ph.D. principal investigator
Friends Research Institute, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DynamiCare Health and Methadone Treatment-As-Usual in people with Opioid Use and Opioid Use Disorder, run by Friends Research Institute, Inc. at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention in Methadone Treatment through 48 Weeks (time frame: 48 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05766631, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.