RecruitingPhase 4NCT05988710

Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia


Sponsor

Vanderbilt University Medical Center

Enrollment

120 participants

Start Date

Oct 19, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Buccal Buprenorphine 300 mcg, a drug called Buccal Buprenorphine 450mcg, and others for people with abuse opioids, analgesia, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 65 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGBuccal Buprenorphine 300 mcg

buprenorphine for 300mcg buccal administration

DRUGBuccal Buprenorphine 600 mcg

buprenorphine for 600mcg buccal administration

DRUGBuccal 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.

DRUGBuccal Placebo

Placebo for buccal administration

DRUGOral Placebo

Placebo for oral administration

DRUGOral immediate-release oxycodone 10mg

Immediate-release oxycodone for 10 mg oral administration

DRUGBuccal Buprenorphine 450mcg

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


Locations(1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05988710


Related Trials