Opioid Use DisorderNCT05832879
Telehealth Treatment for Opioid Use Disorders
A study testing OUD Telehealth Platform in people with Opioid Use Disorder, run by Yale University at 1 site in United States.
Trial summary
This study aims to use an Opioid Use Disorder (OUD) Telehealth Platform to reduce overdose events. This telehealth platform will be pilot tested to evaluate its preliminary efficacy in terms of motivating engagement in medications for OUD (MOUD), as well as its feasibility, acceptability and satisfaction to both first… 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?
- OUD Telehealth Platform
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 24 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Have a history of at least one opioid overdose
- 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) OR be willing to use a device provided by the study team
- 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.
United States1 site
Yale School of Medicine
New Haven, Connecticut, 06520
About this study
Official title: A Pilot Study of Telehealth Treatment for Opioid Use Disorders
This study aims to use an Opioid Use Disorder (OUD) Telehealth Platform to reduce overdose events. This telehealth platform will be pilot tested to evaluate its preliminary efficacy in terms of motivating engagement in medications for OUD (MOUD), as well as its feasibility, acceptability and satisfaction to both first responders/providers and participants.
Read the detailed description
The primary objective of the study is to assess effects of enrollment in a comprehensive telehealth platform, in adults with moderate or severe opioid use disorder with a history of at least one opioid overdose. Adults with moderate or severe opioid use disorder with a history of at least one opioid overdose will be enrolled and the primary endpoint will be attendance at first appointment for medication for opioid use disorder at 30 days.
Secondary aims include assessing engagement in the first MOUD appointment at 90 days and self-report of the number of subsequent overdose events at 30 and 90 days. Exploratory aims include feasibility of intervention, readiness and intention to engage in treatment, acceptability and satisfaction of intervention, and comparison of MOUD engagement with data from previous in-person studies.
- Conditions
- Opioid Use Disorder
- Being tested
- OUD Telehealth Platform
- Keywords
- Harm Reduction, Medication for Opioid Use Disorder
- Medical subject headings
- Opioid-Related Disorders, Harm Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OUD Telehealth PlatformBehavioural
The platform is intended to encourage engagement in treatment with medications for opioid use disorder (MOUD) through a chat dialogue with users
| Study group | Role | What they receive |
|---|---|---|
| OUD Telehealth Platform | Experimental | Participants will be assigned to receive the OUD Telehealth Platform, which will be delivered remotely by research staff. Receives: Behavioral: OUD Telehealth Platform |
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 buprenorphine appointment within 30 days of referral.
Measured: Up to 30 Days
Secondary outcomes (3)
Engagement with MOUD
Engagement will be measured by demonstrated maintained attendance with MOUD treatment within 90 days of referral.
Measured: Up to 90 days
Overdose Events at 30 Days
A self-report of the number of subsequent overdose events at 30 days.
Measured: Up to 30 days
Overdose Events at 90 Days
A self-report of the number of subsequent overdose events at 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 posted27 Apr 2023
- Study start1 May 2024
- Primary completion24 Jul 2025
- Study completion24 Jul 2025
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 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Rebekah Heckmann, MD, MPH, MPA, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05832879
- Sponsor's protocol ID
- 2000034414
- Other IDs
- 1R61DA057675-01
- Status last verified
- Sep 2025
- First submitted
- 14 Apr 2023
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared as part of the HEAL Initiative Consortium.
Publications
Canty T, S Sabounchi N, Heimer R, Pantalon M, Ryus C, Buchanan L, Grewal M, Maffei J, D'Onofrio G, Heckmann R. Increasing timely access to evidence-based treatment for opioid use disorder using novel digital health and system dynamics modelling approaches: a study protocol. BMJ Open. 2025 Nov 4;15(11):e102796. doi: 10.1136/bmjopen-2025-102796.
PubMed 41193189
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Telehealth Treatment for Opioid Use Disorders
- ClinicalTrials.gov ID
- NCT05832879
- Acronym / sponsor ID
- 2000034414
- Conditions
- Opioid Use Disorder
- Keywords
- Harm Reduction, Medication for Opioid Use Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 May 2024 (actual)
- Primary completion
- 24 Jul 2025 (actual)
- Study completion
- 24 Jul 2025 (actual)
- First posted
- 27 Apr 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.
This study aims to use an Opioid Use Disorder (OUD) Telehealth Platform to reduce overdose events. This telehealth platform will be pilot tested to evaluate its preliminary efficacy in terms of motivating engagement in medications for OUD (MOUD), as well as its feasibility, acceptability and satisfaction to both first responders/providers and participants.
Detailed description
The primary objective of the study is to assess effects of enrollment in a comprehensive telehealth platform, in adults with moderate or severe opioid use disorder with a history of at least one opioid overdose. Adults with moderate or severe opioid use disorder with a history of at least one opioid overdose will be enrolled and the primary endpoint will be attendance at first appointment for medication for opioid use disorder at 30 days.
Secondary aims include assessing engagement in the first MOUD appointment at 90 days and self-report of the number of subsequent overdose events at 30 and 90 days. Exploratory aims include feasibility of intervention, readiness and intention to engage in treatment, acceptability and satisfaction of intervention, and comparison of MOUD engagement with data from previous in-person studies.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OUD Telehealth Platform | Experimental | Behavioral: OUD Telehealth PlatformParticipants will be assigned to receive the OUD Telehealth Platform, which will be delivered remotely by research staff. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Can speak, read and write in English
- Provision of signed and dated informed consent form
- Have a history of at least one opioid overdose
- 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) OR be willing to use a device provided by the study team
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 |
|---|---|---|
| OUD Telehealth PlatformThe platform is intended to encourage engagement in treatment with medications for opioid use disorder (MOUD) through a chat dialogue with users | Behavioural | OUD Telehealth 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 buprenorphine appointment within 30 days of referral.
3 secondary outcomes
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
- Derived from this study: PubMed 41193189Canty T, S Sabounchi N, Heimer R, Pantalon M, Ryus C, Buchanan L, Grewal M, Maffei J, D'Onofrio G, Heckmann R. Increasing timely access to evidence-based treatment for opioid use disorder using novel digital health and system dynamics modelling approaches: a study protocol. BMJ Open. 2025 Nov 4;15(11):e102796. doi: 10.1136/bmjopen-2025-102796.
- Individual participant dataSharing planned: Yes. Data will be shared as part of the HEAL Initiative Consortium.
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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.
Rebekah Heckmann, MD, MPH, MPA principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OUD Telehealth 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 6 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: finished, as of the sponsor's last update on 6 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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?
On the ClinicalTrials.gov record for NCT05832879, 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 6 Oct 2025.