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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: Recruiting Phase 4 study of Pain and Analgesia, sponsored by Vanderbilt University Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Difference in mean Emax of the drug liking VAS between oxycodone 10 mg and an equianalgesic dose of buprenorphine conditions. Drug liking VAS is a bipolar scale designed to assess a participant's liking for a given study intervention at the time the question is being asked (that is, at this moment). It is scored as an integer ranging from 0 (strong disliking) to 100 (strong liking).
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 |
What NCT05988710 shows while recruiting
NCT05988710 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 374 other Pain trials with a reported enrollment target (61% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT05988710's enrollment target sits among peer trials
120 135th of 374 higher than 229 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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