Actively Recruiting
Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia
Led by Vanderbilt University Medical Center · Updated on 2026-01-12
120
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Intact cognitive status and ability to provide informed consent
- Ability to read and write in English sufficiently to understand and complete study questionnaires
- Age 18-65
- Opioid-naive status defined as no use of full mu-opioid receptor agonist, partial agonist, or mixed agonist/antagonist medications for the prior 3 months by patient report
You will not qualify if you...
- Liver or kidney disease
- Chronic pain
- Current or prior substance use disorder
- Pregnancy (confirmed by tests)
- Seizure disorder
- Severe depression, bipolar disorder, or psychotic disorders
- Recent use of medications interfering with study drug metabolism
- Recent benzodiazepine or opioid use confirmed by urine screening
- Any medical condition deemed unsafe by the study physician
- Prior allergic reaction or intolerance to oxycodone, buprenorphine, or their analogs including moderate-to-severe nausea or vomiting
- Recent use of marijuana, delta-8 THC, CBD, or similar products
- Recent use of kratom
- Severe asthma
- Long QT syndrome
- Parkinson disease
- Weight less than 60 kg
AI-Screening
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Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37069
Actively Recruiting
Research Team
D
Daniel Larach, MD, MSTR, MA
CONTACT
G
Gail Mayo
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
6
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