NCT05106153

A Study to Determine the Abuse Potential of Seltorexant Compared to Suvorexant and Zolpidem

A Single-Dose, Double-Blind, Placebo-Controlled, Randomized, Crossover Study to Determine the Abuse Potential of Single Oral Dose of Seltorexant Compared To Suvorexant and Zolpidem

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 127 (actual)
• Sponsor: Janssen Research & Development, LLC · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the abuse potential of seltorexant compared to placebo and two active comparators (zolpidem and suvorexant) in non-dependent, recreational sedative users.

Conditions

• Healthy Non-dependent, Recreational Sedative Users
• Abuse Potential

Interventions

Type	Name	Description
DRUG	Suvorexant	Suvorexant will be administered orally as per assigned treatment sequence.
DRUG	Zolpidem	Zolpidem will be administered orally as per assigned treatment sequence.
DRUG	Seltorexant	Seltorexant will be administered orally as per assigned treatment sequence.
DRUG	Placebo	Placebo will be administered orally as per assigned treatment sequence.

Timeline

• Start date: 2021-12-17
• Primary completion: 2023-05-12
• Completion: 2023-05-12
• First posted: 2021-11-03
• Last updated: 2025-04-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study