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NCT05988710 · ClinicalTrials.gov registry record · Phase 4
Low-dose Buccal Buprenorphine: Relative Abuse Potential and Analgesia
A Phase 4 study of Pain and Analgesia, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 120
- Enrollment target
- 1
- Study location
NCT05988710 is a Phase 4 study of Pain and Analgesia that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 120 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (61% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05988710, a Phase 4 study of Pain and Analgesia, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 120 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as Phase 4. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 304-participant average among 374 other Pain trials with a reported enrollment target (61% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
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.
NCT05988710 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
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.
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).
Who is sponsoring clinical trial NCT05988710?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
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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Related
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