Sublingual Buprenorphine Through Telemedicine vs In-Person Care as Usual

Opioid Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05339256
• Other study ID #: 8305
• Secondary ID: R21DA055835
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: January 1, 2025
• Est. completion date: September 1, 2026

Study information

• Verified date: February 2024
• Source: New York State Psychiatric Institute
• Contact: Christina Brezing, MD
• Phone: 646-774-6132
• Email: cb3108[@]columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 with sublingual buprenorphine for outpatients seeking treatment for opioid use disorder (OUD). This telehealth protocol serves as a model of the integration of evidence-based practices in medication for opioid use disorder (MOUD) and could be used by non addiction specialists at scale. The primary outcome will be time to dropout. Participants will have daily study visits (either in person or remote) during the initial buprenorphine induction week and then twice per week during the maintenance phase (either in person or remote) over the 12-week trial. Remote visits will be conducted using the HIPAA-compliant technology, FaceTime and/or Webex.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Drug:
• Buprenorphine SL
Up to 24 mg per day

Other:
• Telehealth
Telehealth MOUD, utilizing a standardized protocol for each healthcare provider session
• In-person treatment as usual
in-person induction and maintenance dosing of sublingual buprenorphine, or MOUD as usual.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
New York State Psychiatric Institute	National Institute on Drug Abuse (NIDA)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to drop out	Comparing time to drop out between the treatment arms	12 weeks