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PF614 50 mg for Recreational Drug Use

Phase 1

Waitlist Available

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 through study completion, an average of 2.5 months

Awards & highlights

Study Summary

This trial will compare the abuse potential of PF614 to oxycodone and placebo. The safety and how PF614 is processed by the body will also be studied.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2.5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2.5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2.5 months 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

Factor Va

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

Nausea/ vomiting

Stomach irritation

Dizziness

Drowsiness

Other

100%

80%

60%

40%

20%

Study treatment Arm

Naproxen Alone

Opioid

Skeletal Muscle Relaxant

Trial Design

5Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: PF614 50 mgExperimental Treatment1 Intervention

PF614 50 mg capsule (1 x 50 mg capsule over-encapsulated and 1 x placebo to match PF614 capsule)

Group II: PF614 200 mgExperimental Treatment1 Intervention

PF614 200 mg capsule (2 x 100 mg capsules)

Group III: PF614 100 mgExperimental Treatment1 Intervention

PF614 100 mg capsule (1 x 100 mg capsule and 1 x placebo to match PF614 capsule)

Group IV: Oxycodone IR 40 mgActive Control1 Intervention

Oxycodone HCl 40 mg (2 x 20 mg capsules over-encapsulated to match PF614 capsules).

Group V: PlaceboPlacebo Group1 Intervention

Placebo capsules to match PF614 (2 x placebo capsules)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

PF614

2022

Completed Phase 1

~210

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ensysce BiosciencesLead Sponsor

5 Previous Clinical Trials

303 Total Patients Enrolled

1 Trials studying Recreational Drug Use

27 Patients Enrolled for Recreational Drug Use

Dr. Vince Clinical ResearchOTHER

1 Previous Clinical Trials

32 Total Patients Enrolled

Lynn Kirkpatrick, PhDStudy ChairEnsysce Biosciences

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the total number of enrollees for this experiment?

"Yes, indeed. Clinicaltrials.gov reveals that this scientific investigation is actively enrolling participants, having been initially posted on October 5th 2022 and recently updated the same day. 36 volunteers are sought out from a single medical centre."

Answered by AI

To whom is enrollment for this trial open?

"Access to this clinical trial is limited to individuals aged 18-55 that have a history of recreational drug use. The researchers are currently seeking 36 enrollees."

Answered by AI

Are there any available slots for volunteers seeking to participate in this clinical experiment?

"Affirmative. Clinicaltrials.gov data supports the claim that this research trial, first posted on October 5th 2022, is actively recruiting for 36 participants from a single site."

Answered by AI

What potential harm could result from ingesting PF614 200 mg?

"As this is a Phase 1 trial, there is only minimal evidence supporting the safety and efficacy of PF614 200 mg. Our team at Power therefore awarded it a score of 1 on our scale."

Answered by AI

Is the age limitation for this trial 65 and lower?

"The requirements for inclusion in this trial stipulate that participants must be older than 18 years old, but younger than 55."

Answered by AI

What goals is this investigation striving to accomplish?

"This trial seeks to measure the Peak Maximum Effect (Emax) of Drug Liking (At this Moment) Visual Analog Scale (VAS) over a 24-hour post-dose duration. Additional objectives account for Area Under the Curve Plasma Concentration (AUC 0-24), Adverse Events leading to discontinuation, and Maximum Plasma Concentration (Cmax)."

Answered by AI

Recent research and studies

Journal of Opioid ManagementJournal

In Vitro and in Vivo Assessment of the Abuse Potential of PF614, a Novel BIO-MD™ Prodrug of Oxycodone

Kirkpatrick, PhD, D. Lynn, William K. Schmidt, PhD, Ricardo Morales, BSc, John Cremin, PhD, Julie Seroogy, BSc, Craig Husfeld, PhD, and Thomas Jenkins, PhD. 2017. “In Vitro and in Vivo Assessment of the Abuse Potential of PF614, a Novel BIO-MD™ Prodrug of Oxycodone”. Journal of Opioid Management. Weston Medical Publishing. doi:10.5055/jom.2017.0366.

clinicaltrials.govStudy

A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users

2022. "A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05571345.