Status:
RECRUITING
Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Analgesia
Abuse Opioids
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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 set...
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
Key Trial Info
Start Date :
October 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT05988710
Start Date
October 19 2023
End Date
October 1 2026
Last Update
December 12 2024
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37069