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Low-Dose Buccal Buprenorphine: Abuse Potential and Pain Relief

This study is looking at how well different doses of buccal buprenorphine (a medication placed in the cheek) relieve pain and how likely it is to be misused, compared to oxycodone. Researchers want to understand if low doses of buprenorphine can provide pain relief with less risk of abuse. You might be able to join if you are between 18 and 65 years old, can read and write in English, and haven't used certain opioid medications in the last three months. The study will measure how much participants "like" the drugs and how well they tolerate pain. The study aims to enroll 120 participants, but its current status is unclear.

Study design
This is an interventional study with a crossover design, meaning participants will receive different treatments at different times. It plans to enroll 120 participants.
What's involved
Participants will attend 5 separate sessions where they will receive oxycodone, placebo, and three different doses of buccal buprenorphine. Pain responsiveness will be measured over 3.5 hours after each drug administration.
Compensation
Not stated in the trial record.
Follow-up
Pain responsiveness and drug liking will be measured for 3.5 hours after each study drug administration.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05988710

Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia

Recruiting
PHASE4Ages 18–65Interventional
Vanderbilt University Medical Center
~120 participants
Updated 2026-01-12 on ClinicalTrials.gov
What's tested:Buccal Buprenorphine 300 mcgBuccal Buprenorphine 600 mcgBuccal Buprenorphine 900 mcgBuccal PlaceboOral PlaceboOral immediate-release oxycodone 10mg

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Difference in mean maximum effect score (Emax) of the drug liking visual analog scale (VAS) between oxycodone 10 mg and an equianalgesic dose of buprenorphine
Measured over Baseline through 3.5 hours after study drug administration on each medication condition
+1 more outcome measured

Conditions

Analgesia
Abuse Opioids
Pain

Explore related trials

Healthy

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

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

Who to contact

Daniel Larach, MD, MSTR, MA
[email protected]
615-322-6033
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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 (MOR) agonist, partial MOR agonist, or mixed agonist/antagonist medications for the prior 3 months by patient report

Exclusion

Liver/kidney disease
Chronic pain
Current/prior substance use disorder
Pregnancy (to avoid fetal drug exposure, with pregnancy tests conducted to confirm eligibility)
Seizure disorder
Certain psychiatric conditions (severe depression, bipolar disorder, psychotic disorders)
Recent use of medications that may interfere with study drug metabolism
Recent benzodiazepine or opioid use (confirmed via rapid urine screening prior to each lab session)
The presence of any medical conditions felt by the study physician to render participant unsafe
Prior allergic reaction or intolerance to oxycodone, buprenorphine, or their analogs (explicitly including moderate-to-severe nausea or vomiting with prior opioids)
Recent use of marijuana, delta-8 THC, CBD, and similar products
Recent use of kratom
Severe asthma
Long QT syndrome
Parkinson disease
Weight \<60 kg

What this trial measures

  • Difference in mean maximum effect score (Emax) of the drug liking visual analog scale (VAS) between oxycodone 10 mg and an equianalgesic dose of buprenorphineBaseline through 3.5 hours after study drug administration on each medication condition

    Difference in mean Emax of the drug liking VAS between oxycodone 10 mg and an equianalgesic dose of buprenorphine conditions. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).

  • Quantitative sensory testing (QST) thermal pain tolerance in secondsBaseline through 3.5 hours after study drug administration on each medication condition

    Mean time in seconds elapsed from onset of the heat pain stimulus to participants withdrawal from the stimulus. Heat pain tolerance is an indicator of pain sensitivity. This will determine the equianalgesic dose of buccal buprenorphine compared to oxycodone 10 mg. Equivalence to oxycodone will be defined as the buprenorphine does that produces a mean thermal pain tolerance increase within 0.5 standard deviation of the oxycodone. response.