NCT05988710 Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia
| NCT ID | NCT05988710 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Analgesia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2023-10-19 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2023-10-19 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 setting. This is a translational study in which healthy participants are phenotyped for psychosocial and Opioid-Use-Disorder-risk-related metrics. In a within-subjects crossover design, 60 participants will receive a standard postoperative oral oxycodone dose (10 mg), placebo, and 3 different doses of buccal buprenorphine across 5 separate sessions. Quantitative Sensory Testing (QST) will be used to evaluate alterations in pain responsiveness relative to placebo across buprenorphine doses and oxycodone, and will compare abuse potential (indexed by the standard FDA drug liking metric) following equianalgesic doses of the two drugs.
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
Contact & Investigator
Daniel Larach, MD, MSTR, MA
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT05988710 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Analgesia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05988710 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05988710 currently recruiting?
Yes, NCT05988710 is actively recruiting participants. Contact the research team at daniel.larach@vumc.org for enrollment information.
Where is the NCT05988710 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT05988710 clinical trial?
NCT05988710 is sponsored by Vanderbilt University Medical Center. The principal investigator is Daniel Larach, MD, MSTR, MA at Vanderbilt University Medical Center. The trial plans to enroll 120 participants.