Opioid Use DisorderPhase 2NCT05339256
Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual
A Phase 2 study testing Buprenorphine SL, Telehealth and In-person treatment as usual in people with Opioid Use Disorder, run by New York State Psychiatric Institute.
Trial summary
This study will compare in-person induction and maintenance dosing of sublingual buprenorphine to induction and maintenance dosing of sublingual buprenorphine through comprehensive telehealth sessions and telehealth medication for opioid use disorder (MOUD). 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?
- Buprenorphine SL, Telehealth and In-person treatment as usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 31 Dec 2026
- Phase
- Phase 2
- 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
- meet DSM-5 criteria for OUD
- Voluntarily seeking buprenorphine treatment for OUD
- Able to provide informed consent and comply with study procedures
Who cannot join
- Meeting DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis that would compromise safety of participation in the trial as determined by the study physician, such as an alcohol or sedative hypnotic use disorder that requires detoxification
- Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as a psychotic disorder including schizophrenia or schizoaffective disorder
- Concurrent methadone, buprenorphine, or vivitrol maintenance treatment
- Known history of allergy, intolerance, or hypersensitivity to candidate medication (buprenorphine)
- Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients
- Unstable medical conditions, such as severe hepatic, renal, or cardiovascular disease, which might make participation
- Current or recent history history of significant violent or suicidal behavior or risk for suicide or homicide
- Legally mandated to substance use disorder treatment.
About this study
Official title: A Randomized, Controlled Trial of Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual in the Treatment of Opioid Use Disorder
This study will compare in-person induction and maintenance dosing of sublingual buprenorphine to induction and maintenance dosing of sublingual buprenorphine through comprehensive telehealth sessions and telehealth medication for opioid use disorder (MOUD).
Read the detailed description
The study is a 12-week, randomized, active-control, open-label, early phase II effectiveness trial of telemedicine treatment using sublingual buprenorphine as compared to in person clinic treatment with sublingual buprenorphine for outpatients seeking treatment for opioid use disorder (OUD). This telehealth protocol serves as a model of the integration of evidence-based practices in medication for opioid use disorder (MOUD) and could be used by non addiction specialists at scale. The primary outcome will be time to dropout. Participants will have daily study visits (either in person or remote) during the initial buprenorphine induction week and then twice per week during the maintenance phase (either in person or remote) over the 12-week trial. Remote visits will be conducted using the HIPAA-compliant technology, FaceTime and/or Webex.
- Conditions
- Opioid Use Disorder
- Being tested
- Buprenorphine SL, Telehealth, In-person treatment as usual
- 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.
Buprenorphine SLDrug
Up to 24 mg per day
TelehealthOther
Telehealth MOUD, utilizing a standardized protocol for each healthcare provider session
In-person treatment as usualOther
in-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual.
| Study group | Role | What they receive |
|---|---|---|
| Telehealth buprenorphine induction and maintenance | Experimental | Sublingual (SL) Buprenorphine and a medical management protocol adapted to the unique needs of home-based telehealth for MOUD using SL buprenorphine Receives: Drug: Buprenorphine SL; Other: Telehealth |
| Standard in-person SL buprenorphine induction and maintenance | Active comparator | In-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual. Receives: Drug: Buprenorphine SL; Other: In-person treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to drop out
Comparing time to drop out between the treatment arms
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Why it stopped: Due to a federally mandated, institution-wide pause in research activities under the institution's Federal Wide Assurance (FWA) that occurred during the timeline for this study, recruitment was never initiated and no participants were enrolled.
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized, active-control, open-label
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Christina Ann Brezing, New York State Psychiatric Institute
- Investigators
- Christina Brezing, MD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05339256
- Sponsor's protocol ID
- 8305
- Other IDs
- R21DA055835
- Status last verified
- Apr 2026
- First submitted
- 14 Apr 2022
- Last updated
- 8 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures)
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial of Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual in the Treatment of Opioid Use Disorder
- ClinicalTrials.gov ID
- NCT05339256
- Acronym / sponsor ID
- 8305
- Conditions
- Opioid Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to a federally mandated, institution-wide pause in research activities under the institution's Federal Wide Assurance (FWA) that occurred during the timeline for this study, recruitment was never initiated and no participants were enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Apr 2022 (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 will compare in-person induction and maintenance dosing of sublingual buprenorphine to induction and maintenance dosing of sublingual buprenorphine through comprehensive telehealth sessions and telehealth medication for opioid use disorder (MOUD).
Detailed description
The study is a 12-week, randomized, active-control, open-label, early phase II effectiveness trial of telemedicine treatment using sublingual buprenorphine as compared to in person clinic treatment with sublingual buprenorphine for outpatients seeking treatment for opioid use disorder (OUD). This telehealth protocol serves as a model of the integration of evidence-based practices in medication for opioid use disorder (MOUD) and could be used by non addiction specialists at scale. The primary outcome will be time to dropout. Participants will have daily study visits (either in person or remote) during the initial buprenorphine induction week and then twice per week during the maintenance phase (either in person or remote) over the 12-week trial. Remote visits will be conducted using the HIPAA-compliant technology, FaceTime and/or Webex.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- randomized, active-control, open-label
| Arm | Type | Receives |
|---|---|---|
| Telehealth buprenorphine induction and maintenance | Experimental | Drug: Buprenorphine SL, Other: TelehealthSublingual (SL) Buprenorphine and a medical management protocol adapted to the unique needs of home-based telehealth for MOUD using SL buprenorphine |
| Standard in-person SL buprenorphine induction and maintenance | Active comparator | Drug: Buprenorphine SL, Other: In-person treatment as usualIn-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- meet DSM-5 criteria for OUD
- Voluntarily seeking buprenorphine treatment for OUD
- Able to provide informed consent and comply with study procedures
Key exclusion criteria (8 listed)
- Meeting DSM-5 criteria for substance use disorder other than opioid as the primary diagnosis that would compromise safety of participation in the trial as determined by the study physician, such as an alcohol or sedative hypnotic use disorder that requires detoxification
- Having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as a psychotic disorder including schizophrenia or schizoaffective disorder
- Concurrent methadone, buprenorphine, or vivitrol maintenance treatment
- Known history of allergy, intolerance, or hypersensitivity to candidate medication (buprenorphine)
- Pregnancy, lactation, or failure to use adequate contraceptive methods in female patients
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 |
|---|---|---|
| Buprenorphine SLUp to 24 mg per day | Drug | Standard in-person SL buprenorphine induction and maintenance, Telehealth buprenorphine induction and maintenance |
| TelehealthTelehealth MOUD, utilizing a standardized protocol for each healthcare provider session | Other | Telehealth buprenorphine induction and maintenance |
| In-person treatment as usualin-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual. | Other | Standard in-person SL buprenorphine induction and maintenance |
Primary outcome
Time to drop out
Time frame: 12 weeks
Comparing time to drop out between the treatment arms
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results published in this report (after de-identification) (text, tables, figures)
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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.
Christina Brezing, MD principal investigator
New York State Psychiatric Institute
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Buprenorphine SL, Telehealth and In-person treatment as usual in people with Opioid Use Disorder, run by New York State Psychiatric Institute.
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 8 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: withdrawn, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Time to drop out (time frame: 12 weeks). 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 8 Sep 2026.