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A Study to Evaluate the Intranasal Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-103)

NCT05567354 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2024-09-24

No results posted yet for this study

Summary

The purpose of this study is to examine the abuse potential and pharmacokinetics of PF614 compared with a non-abuse deterrent, commercially available, immediate release (IR) oxycodone hydrochloride (HCl) formulation and placebo.

Conditions

  • Recreational Drug Use

Interventions

DRUG

PF614

PF614 100 mg capsules

DRUG

Oxycodone

Oxycodone HCl IR 40mg

OTHER

Placebo

placebo powder

Sponsors & Collaborators

  • Ensysce Biosciences

    lead INDUSTRY

Principal Investigators

  • Glen Apseloff, MD, FCP · Ohio Clinical Trials

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-10
Primary Completion
2022-08-31
Completion
2022-08-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05567354 on ClinicalTrials.gov