NCT01987739

Study to Evaluate the Relative Abuse Potential of Almorexant in Recreational Drug Users

A Single Center, Randomized, Double-blind, Double-dummy, Placebo- and Active-controlled, Six-way Crossover Single-dose Study to Evaluate the Relative Abuse Potential of Almorexant in Recreational Central Nervous System (CNS) Depressant Drug Users

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Midnight Pharma, LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This was a six-way crossover study with six single-dose treatment sessions. The profile of acute effects on abuse potential measures of different almorexant doses was compared to that of placebo and two doses of zolpidem

Detailed description

This was a prospective, randomized, double-blind, double-dummy, balanced, placebo and active-controlled, six-way crossover Phase 1 study with six single-dose treatment sessions. The profile of acute effects on pharmacodynamic abuse potential measures of different almorexant doses was compared with that of placebo and two doses of zolpidem.

Conditions

• Abuse Potential Study

Interventions

Type	Name	Description
DRUG	200 mg almorexant
DRUG	400 mg almorexant
DRUG	1000 mg almorexant
DRUG	20 mg zolpidem
DRUG	40 mg zolpidem
DRUG	placebo

Timeline

• Start date: 2009-09-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2013-11-19
• Last updated: 2016-02-12