Not_yet_recruitingPHASE2NCT05339256

A Randomized, Controlled Trial of Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual in the Treatment of Opioid Use Disorder

Sponsor: New York State Psychiatric Institute

Trial Details

ConditionOpioid Use Disorder
InterventionBuprenorphine SL; Telehealth; In-person treatment as usual
PhasePHASE2
StatusNot_yet_recruiting
Participants50
Est. Completion31 Dec 2026
Last Updated13 Apr 2026

Primary Outcome

Time to drop out

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria: * meet DSM-5 criteria for OUD * Voluntarily seeking buprenorphine treatment for OUD * Able to provide informed consent and comply with study procedures Exclusion Criteria: * 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.

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