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NCT05571345
A Study to Evaluate the Oral Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-104)
Phase 1 trial testing PF614 in Recreational Drug Use in 32 participants. Completed in 28 December 2022.
23 December 2022
Quick facts
| Lead sponsor | Ensysce Biosciences |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 32 |
| Start date | 5 October 2022 |
| Primary completion | 23 December 2022 |
| Estimated completion | 28 December 2022 |
| Sites | 1 location across United States |
Drugs / interventions tested
- PF614 — full drug profile →
- Oxycodone Hydrochloride 40 mg
- Placebo
Conditions studied
- Recreational Drug Use — all drugs for Recreational Drug Use →
Sponsor
Ensysce Biosciences — full company profile →
Who can join
Adults 18 to 55, any sex, with Recreational Drug Use. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05571345
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PF614
Trials testing the same drug.
- NCT06629402 — Assessment of PF614 Effects on Experimental Pain in the Cold Pressure Test (PF614-201) · Phase 2 · completed
- NCT05567354 — A Study to Evaluate the Intranasal Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-103) · Phase 1 · completed
- NCT05043766 — Evaluation of Oral PF614 Relative to OxyContin (PF614-102) · Phase 1 · completed
- NCT02454712 — Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101) · Phase 1 · completed
Other Ensysce Biosciences trials
Trials by the same sponsor.
- NCT06500793 — Single Dose Study, Pharmacokinetics of Oxycodone and PF614 Co-Administered With Nafamostat (PF614-MPAR-102) · Phase 1 · recruiting
- NCT06629402 — Assessment of PF614 Effects on Experimental Pain in the Cold Pressure Test (PF614-201) · Phase 2 · completed
- NCT05567354 — A Study to Evaluate the Intranasal Abuse Potential of PF614 in Non-Dependent Recreational Opioid Users (PF614-103) · Phase 1 · completed
- NCT05090280 — Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-101) · Phase 1 · completed
- NCT05043766 — Evaluation of Oral PF614 Relative to OxyContin (PF614-102) · Phase 1 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05571345 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ensysce Biosciences
- Last refreshed: 24 September 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05571345.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing