Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual

Sponsor
New York State Psychiatric Institute
Study ID
NCT05339256
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Buprenorphine SL — DRUG
    Up to 24 mg per day
  • Telehealth — OTHER
    Telehealth MOUD, utilizing a standardized protocol for each healthcare provider session
  • In-person treatment as usual — OTHER
    in-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual.

Study Details

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).

Key Dates

First listed
Apr 21, 2022
Start date
Jun 1, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Telehealth buprenorphine induction and maintenance
    Sublingual (SL) Buprenorphine and a medical management protocol adapted to the unique needs of home-based telehealth for MOUD using SL buprenorphine
  • Active Comparator: Standard in-person SL buprenorphine induction and maintenance
    In-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual.

Primary Outcome Measure

Time to drop out [ Time Frame: 12 weeks ]

Central Contacts

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