Status:
NOT_YET_RECRUITING
Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Opioid Use Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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...
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 wi...
Eligibility Criteria
Inclusion
- meet DSM-5 criteria for OUD
- Voluntarily seeking buprenorphine treatment for OUD
- Able to provide informed consent and comply with study procedures
Exclusion
- 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.
Key Trial Info
Start Date :
February 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05339256
Start Date
February 1 2026
End Date
December 31 2026
Last Update
October 31 2025
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