Comparing low-dose buccal buprenorphine to standard opioids for pain relief and abuse potential
Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia
This study is testing if a low-dose form of buprenorphine can relieve pain and has less potential for abuse compared to the standard opioid oxycodone, using healthy volunteers.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05988710 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are healthy adults aged 18-65 who have not used opioids in the past three months.
Not a fit: Patients with chronic pain, current or prior substance use disorders, or certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer alternative to traditional opioids for pain management with a lower risk of abuse.
How similar studies have performed: Other studies have explored the safety and efficacy of buprenorphine, but this specific approach comparing low-dose buccal buprenorphine to oxycodone is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nashville, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.