Opioid Use DisorderNCT07362082
A Clinical Trial of Telehealth Treatment for Opioid Use Disorders
A study testing RecoveryPad platform in people with Opioid Use Disorder, run by Yale University at 1 site in United States.
Trial summary
This trial will assess effects of enrollment in a comprehensive telehealth platform, RecoveryPad (RP), in adults with moderate or severe opioid use disorder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use Disorder
- What is being tested?
- RecoveryPad platform
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 470 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Sep 2026to 1 Dec 2027
- Phase
- Interventional
- 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
- Can speak, read and write in English
- Provision of signed and dated informed consent form
- Screened positive for OUD, moderate or severe, based on the Diagnostic and Statistical Manual-5th Edition
- Have a working cell phone number and working device that can access a web browser and receive texts (i.e., smartphone, tablet or computer)
- Can provide a working email address OR be willing to create one
Who cannot join
- Current use of buprenorphine, methadone, or naltrexone for a substance use disorder
- Pregnancy
- Known current suicide risk based on participant self-report
- On parole or incarcerated at time of enrollment based on participant self-report
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Yale University
New Haven, Connecticut, 06520
About this study
Official title: A Randomized Clinical Trial of Telehealth Treatment for Opioid Use Disorders
This trial will assess effects of enrollment in a comprehensive telehealth platform, RecoveryPad (RP), in adults with moderate or severe opioid use disorder.
- Conditions
- Opioid Use Disorder
- Being tested
- RecoveryPad platform
- 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.
RecoveryPad platformDevice
Telehealth platform to enhance motivation and engagement in treatment for OUD
| Study group | Role | What they receive |
|---|---|---|
| RecoveryPad platform | Experimental | Participants randomized to RecoveryPad platform Receives: Device: RecoveryPad platform |
| Treatment as usual | No intervention | Treatment as usual: referrals to harm reduction and other community resources that are already being given to individuals in the various community and healthcare settings from which these participants are being recruited. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attendance for MOUD
Overall attendance will be measured by attendance (yes or no) at the first MOUD appointment within 30 days of enrollment.
Measured: Up to 30 days
Secondary outcomes (4)
Attendance for MOUD
Overall attendance will be measured by attendance (yes or no) at the first MOUD appointment within 31 to 90 days of enrollment.
Measured: Up to 90 days
Engagement with MOUD
Engagement will be measured by demonstrated maintained attendance with MOUD treatment within 90 days of enrollment.
Measured: Up to 90 days
Overdose Events at 30 Days
A self-report of the number of subsequent overdose events within 30 days.
Measured: Up to 30 days
Overdose Events at 90 Days
A self-report of the number of subsequent overdose events within 90 days.
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start11 Sep 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Use DisorderStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 470 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), City University of New York, School of Public Health
- Responsible party
- Sponsor
- Investigators
- Rebekah Heckmann, MD, Principal investigator, Yale UniversityNasim Sabounchi, PhD, Principal investigator, CUNY Graduate School of Public Health & Health Policy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362082
- Sponsor's protocol ID
- 2000042683
- Other IDs
- 4R33DA057675-02, 1R61DA057675-01, 2000041129
- Status last verified
- Sep 2026
- First submitted
- 21 Jan 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: In accordance with the HEAL Public Access and Data Sharing policy, de-identified IPD underlying the results reported in study-related publications will be shared. These will include participant-level data such as demographics/baseline characteristics, randomization results, and primary and secondary outcome measures.Direct identifiers will not be shared. Data will be de-identified using accepted standards.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Telehealth Treatment for Opioid Use Disorders
- ClinicalTrials.gov ID
- NCT07362082
- Acronym / sponsor ID
- 2000042683
- Conditions
- Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 470 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA), City University of New York, School of Public Health
- Study start
- 11 Sep 2026 (actual)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 23 Jan 2026 (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.
This trial will assess effects of enrollment in a comprehensive telehealth platform, RecoveryPad (RP), in adults with moderate or severe opioid use disorder.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RecoveryPad platform | Experimental | Device: RecoveryPad platformParticipants randomized to RecoveryPad platform |
| Treatment as usual | No intervention | –Treatment as usual: referrals to harm reduction and other community resources that are already being given to individuals in the various community and healthcare settings from which these participants are being recruited. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Can speak, read and write in English
- Provision of signed and dated informed consent form
- Screened positive for OUD, moderate or severe, based on the Diagnostic and Statistical Manual-5th Edition
- Have a working cell phone number and working device that can access a web browser and receive texts (i.e., smartphone, tablet or computer)
- Can provide a working email address OR be willing to create one
Key exclusion criteria (4 listed)
- Current use of buprenorphine, methadone, or naltrexone for a substance use disorder
- Pregnancy
- Known current suicide risk based on participant self-report
- On parole or incarcerated at time of enrollment based on participant self-report
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 |
|---|---|---|
| RecoveryPad platformTelehealth platform to enhance motivation and engagement in treatment for OUD | Device | RecoveryPad platform |
Primary outcome
Attendance for MOUD
Time frame: Up to 30 days
Overall attendance will be measured by attendance (yes or no) at the first MOUD appointment within 30 days of enrollment.
4 secondary outcomes
Attendance for MOUD
Time frame: Up to 90 days
Engagement with MOUD
Time frame: Up to 90 days
Overdose Events at 30 Days
Time frame: Up to 30 days
Overdose Events at 90 Days
Time frame: Up to 90 days
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 21 Sep 2026.
- Individual participant dataSharing planned: Yes. In accordance with the HEAL Public Access and Data Sharing policy, de-identified IPD underlying the results reported in study-related publications will be shared. These will include participant-level data such as demographics/baseline characteristics, randomization results, and primary and secondary outcome measures.Direct identifiers will not be shared. Data will be de-identified using accepted standards.
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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.
Rebekah Heckmann, MD principal investigator
Yale University
Nasim Sabounchi, PhD principal investigator
CUNY Graduate School of Public Health & Health Policy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RecoveryPad platform in people with Opioid Use Disorder, run by Yale University at 1 site 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 5 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: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Contact Rebekah Heckmann, MD ((203) 737-8335, rebekah.heckmann@yale.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attendance for MOUD (time frame: Up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Sep 2026.