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NCT05571345 · ClinicalTrials.gov registry record · Phase 1
A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-104)
A Phase 1 study, sponsored by Ensysce Biosciences.
- Completed
- Registry status
- Phase 1
- Development phase
- 32
- Enrollment target
NCT05571345: Completed Phase 1 study, sponsored by Ensysce Biosciences.
NCT05571345 is a Phase 1 study that has completed, run by Ensysce Biosciences. The registered enrollment target is 32 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05571345, a Phase 1 study, has completed, sponsored by Ensysce Biosciences.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 32 participants
- Enrollment target
Study Summary
This will be a randomized, double-blind, placebo- and active-controlled, 5-way crossover study to evaluate the abuse potential, safety and pharmacokinetics of orally administered PF614 relative to oxycodone IR (immediate-release) tablets and placebo.
Primary Outcome
Relative abuse potential of PF614 compared to Oxycodone and Placebo (I). Emax for drug liking VAS will be reported. 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).
Interventions
- DRUG Placebo
- DRUG PF614
- DRUG Oxycodone Hydrochloride 40 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2022-10-05 |
| Est. Completion | 2022-12-28 |
| Phase | Phase 1 |
What the finished NCT05571345 record still lists
NCT05571345 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 32 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT05571345 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05571345 about?
NCT05571345 is a clinical study titled "A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-104)". This will be a randomized, double-blind, placebo- and active-controlled, 5-way crossover study to evaluate the abuse potential, safety and pharmacokinetics of orally administered PF614 relative to oxycodone IR (immediate-release) tablets and placebo.
What is the current status of trial NCT05571345?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 32 participants. The study started on 2022-10-05. Estimated completion is 2022-12-28.
What interventions are being tested in trial NCT05571345?
The interventions under investigation include: Placebo (DRUG), PF614 (DRUG), Oxycodone Hydrochloride 40 mg (DRUG).
Who is sponsoring clinical trial NCT05571345?
This trial is sponsored by Ensysce Biosciences, which has 9 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05571345's enrollment target sits among peer trials
32 1296th of 2000 higher than 679 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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