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PF614 100 mg capsule for Recreational Drug Use

Phase 1
Waitlist Available
Led By Glen Apseloff, MD, FCP
Research Sponsored by Ensysce Biosciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 and 24 hours post-dose
Awards & highlights

Summary

This trial will help researchers understand if PF614, a new pain medication, has a higher potential for abuse than a similar medication that's already on the market.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 and 24 hours post-dose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 and 24 hours post-dose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmaceutical Preparations
Take Drug again VAS (Emax)
Secondary outcome measures
AEs leading to discontinuation
Adverse events (AEs)
Area Under the Curve Plasma Concentration (AUC 0-24)
+3 more

Side effects data

From 2014 Phase 4 trial • 323 Patients • NCT01587274
6%
Nausea/ vomiting
5%
Stomach irritation
4%
Dizziness
4%
Drowsiness
3%
Other
100%
80%
60%
40%
20%
0%
Study treatment Arm
Naproxen Alone
Opioid
Skeletal Muscle Relaxant

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: PF614 100 mg capsuleExperimental Treatment1 Intervention
Eligible subjects will be admitted to the clinical site on Day-1. Subjects will receive PF614 100mg capsules in a randomized, double-blind, crossover manner.
Group II: Oxycodone HCl tabletsActive Control1 Intervention
Eligible subjects will be admitted to the clinical site on Day -1. Subjects will receive crushed oxycodone HCl IR 40mg in a randomized, double-blind, crossover manner.
Group III: Placebo powder in capsulesPlacebo Group1 Intervention
Eligible subjects will be admitted to the clinical site on Day-1. Subjects will receive Placebo powder in a randomized, double-blind, crossover manner.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PF614
2022
Completed Phase 1
~210

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Ensysce BiosciencesLead Sponsor
6 Previous Clinical Trials
358 Total Patients Enrolled
1 Trials studying Recreational Drug Use
32 Patients Enrolled for Recreational Drug Use
Glen Apseloff, MD, FCPPrincipal InvestigatorOhio Clinical Trials
~9 spots leftby Sep 2025
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