Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual

• Status: Not yet recruiting
• Trial end date: 2024-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Buprenorphine

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.