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NCT04251819 · ClinicalTrials.gov registry record · Phase 2
Buprenorphine Plus Baclofen to Increase Analgesia in Healthy Volunteers
A Phase 2 study, sponsored by University of Alabama at Birmingham.
- Terminated
- Registry status
- Phase 2
- Development phase
- 19
- Enrollment target
NCT04251819: Clinical Trial Phase 2 study, sponsored by University of Alabama at Birmingham.
NCT04251819 is a Phase 2 study that was terminated before completion, run by University of Alabama at Birmingham. The registered enrollment target is 19 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04251819, a Phase 2 study, was terminated before completion, sponsored by University of Alabama at Birmingham.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 19 participants
- Enrollment target
Study Summary
To determine if baclofen will enhance buprenorphine analgesia for acute pain in healthy volunteers.
Primary Outcome
Pain threshold refers to the intensity at which a stimulus is first perceived as painful. Heat stimuli will be delivered using a computer-controlled thermal stimulation system with a 30 millimeter X 30 millimeter probe. From a baseline of 32 degrees Celsius, the probe temperature will increase at a rate of .5 degrees Celsius/second until the participant responds by pressing a button on a handheld device. For heat pain threshold, participants will be instructed to press the button when the sensat
Interventions
- DRUG Placebos
- DRUG Baclofen 5 mg
- DRUG Baclofen 10mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 19 participants |
| Start Date | 2021-01-21 |
| Est. Completion | 2024-06-15 |
| Phase | Phase 2 |
Why NCT04251819 stopped before completion
NCT04251819 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 19 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebos is the first listed.
NCT04251819 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04251819 about?
NCT04251819 is a clinical study titled "Buprenorphine Plus Baclofen to Increase Analgesia in Healthy Volunteers". To determine if baclofen will enhance buprenorphine analgesia for acute pain in healthy volunteers.
What is the current status of trial NCT04251819?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 19 participants. The study started on 2021-01-21. Estimated completion is 2024-06-15.
What interventions are being tested in trial NCT04251819?
The interventions under investigation include: Placebos (DRUG), Baclofen 5 mg (DRUG), Baclofen 10mg (DRUG).
Who is sponsoring clinical trial NCT04251819?
This trial is sponsored by University of Alabama at Birmingham, which has 1,160 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04251819's enrollment target sits among peer trials
19 1894th of 2000 higher than 103 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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