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Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia
NCT05988710 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Oral Placebo
- DRUG Buccal Buprenorphine 300 mcg
- DRUG Buccal Buprenorphine 600 mcg
- DRUG Buccal Buprenorphine 900 mcg
- DRUG Buccal Placebo
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2023-10-19 |
| Est. Completion | 2028-02 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05988710
The ClinicalTrials.gov registry entry for NCT05988710 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University Medical Center, which has 695 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 3 conditions, with Pain appearing as the primary indexed condition, and to 5 interventions — of which Oral Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05988710 reports 1 study location spanning 1 distinct geographic area — top geographies include Tennessee. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05988710 about?
NCT05988710 is a clinical study titled "Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia". 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 an...
What is the current status of trial NCT05988710?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 120 participants. The study started on 2023-10-19. Estimated completion is 2028-02.
What conditions does trial NCT05988710 study?
This clinical trial studies the following conditions: Pain, Analgesia, Abuse Opioids. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05988710?
The interventions under investigation include: Oral Placebo (DRUG), Buccal Buprenorphine 300 mcg (DRUG), Buccal Buprenorphine 600 mcg (DRUG), Buccal Buprenorphine 900 mcg (DRUG), Buccal Placebo (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05988710?
This trial is sponsored by Vanderbilt University Medical Center, which has 695 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05988710 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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