Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Aug 8, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the safety and potential for abuse of new low-dose buccal buprenorphine compared to a common pain medication called oxycodone. The aim is to see how well buprenorphine can manage pain while also understanding if it poses a risk for misuse. To do this, 60 healthy people will take different doses of buprenorphine, oxycodone, and a placebo (a fake treatment) in separate sessions. Researchers will measure how effective these medications are for pain relief and how much participants like the medications, which helps assess their potential for abuse.

To be eligible for the study, participants must be between 18 and 65 years old, able to understand English, and should not have used certain opioid medications for the past three months. They should also not have any serious health conditions or a history of substance abuse. Participants can expect to attend several sessions, where they will receive different treatments and undergo tests to evaluate their pain response. This study is important because it could help determine a safer option for pain management that minimizes the risk of addiction.

Gender

ALL

Eligibility 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