Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia

PHASE4RecruitingINTERVENTIONAL
Enrollment

120

Participants

Timeline

Start Date

October 19, 2023

Primary Completion Date

October 31, 2026

Study Completion Date

October 31, 2026

Conditions
AnalgesiaAbuse OpioidsPain
Interventions
DRUG

Buccal Buprenorphine 300 mcg

buprenorphine for 300mcg buccal administration

DRUG

Buccal Buprenorphine 600 mcg

buprenorphine for 600mcg buccal administration

DRUG

Buccal Buprenorphine 900 mcg

buprenorphine for 900mcg buccal administration. Note: This arm has been discontinued as of 06/25/2024 and has been replaced with the 450mcg buprenorphine buccal administration arm.

DRUG

Buccal Placebo

Placebo for buccal administration

DRUG

Oral Placebo

Placebo for oral administration

DRUG

Oral immediate-release oxycodone 10mg

Immediate-release oxycodone for 10 mg oral administration

DRUG

Buccal Buprenorphine 450mcg

buprenorphine for 450mcg buccal administration. Note: This arm has been added to replace the 900mcg buprenorphine buccal administration arm.

Trial Locations (1)

37069

RECRUITING

Vanderbilt University Medical Center, Nashville

All Listed Sponsors
collaborator

National Institute on Drug Abuse (NIDA)

NIH

lead

Vanderbilt University Medical Center

OTHER

NCT05988710 - Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia | Biotech Hunter | Biotech Hunter