Comparing low-dose buccal buprenorphine to standard opioids for pain relief and abuse potential

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the abuse potential and analgesic effects of low-dose buccal buprenorphine compared to a commonly used opioid, oxycodone, in a controlled setting. It will involve 60 healthy participants who will undergo a within-subjects crossover design, receiving different doses of buprenorphine, placebo, and oxycodone across multiple sessions. Participants will be assessed for pain responsiveness and drug liking metrics to determine the relative safety and efficacy of buprenorphine as an alternative to traditional opioids.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Daniel Larach, MD, MSTR, MA — Vanderbilt University Medical Center
• Study coordinator: Daniel Larach, MD, MSTR, MA
• Email: daniel.larach@vumc.org
• Phone: 615-322-6033

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.