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WithdrawnPhase 2
Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual
Key facts
- Who runs it
- New York State Psychiatric Institute
- Trial code
- Status
- Withdrawn
- Phase
- Phase 2
- Started
- 1 Jun 2026
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Buprenorphine SL
- Telehealth
- In-person treatment as usual
- Record updated
- 8 September 2026
- 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.
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- meet DSM-5 criteria for OUD
- Voluntarily seeking buprenorphine treatment for OUD
- Able to provide informed consent and comply with study procedures
Who cannot take part
- Concurrent methadone, buprenorphine, or vivitrol maintenance treatment
- 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
- 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 the trial
What the trial wants to find out
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).
The 2 groups in the trial
- Telehealth buprenorphine induction and maintenanceTreatment being tested
Sublingual (SL) Buprenorphine and a medical management protocol adapted to the unique needs of home-based telehealth for MOUD using SL buprenorphine
Treatment: Buprenorphine SL and Telehealth
- Standard in-person SL buprenorphine induction and maintenanceExisting treatment, for comparison
In-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual.
Treatment: Buprenorphine SL and In-person treatment as usual
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Randomized, Controlled Trial of Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual in the Treatment of Opioid Use Disorder
- Record updated
- 8 September 2026