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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Withdrawn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