Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia

Summary

The goal of this study is to compare the abuse potential of low-dose equianalgesic buccal buprenorphine to a commonly used full mu opioid receptor (MOR) agonist in a highly controlled experimental setting. This is a translational study in which healthy participants are phenotyped for psychosocial and Opioid-Use-Disorder-risk-related metrics. In a within-subjects crossover design, 60 participants will receive a standard postoperative oral oxycodone dose (10 mg), placebo, and 3 different doses of buccal buprenorphine across 5 separate sessions. Quantitative Sensory Testing (QST) will be used to evaluate alterations in pain responsiveness relative to placebo across buprenorphine doses and oxycodone, and will compare abuse potential (indexed by the standard FDA drug liking metric) following equianalgesic doses of the two drugs.

Conditions

• Analgesia
• Abuse Opioids
• Pain

Interventions

DRUG

Oral immediate-release oxycodone 10mg

Immediate-release oxycodone for 10 mg oral administration

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

Buccal Buprenorphine 450mcg

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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA)

  collaborator NIH

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Daniel Larach, MD, MSTR, MA · Vanderbilt University Medical Center

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-10-19

Primary Completion

2028-01-31

Completion

2028-02-29

FDA Drug

Yes

Countries

• United States

Study Locations