NCT03937986

Suvorexant and Cocaine

Influence of Orexin Antagonism on Motivation for Cocaine

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: William Stoops · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The research proposed here will translate findings from preclinical research and provide the initial clinical evidence that orexin antagonism reduces motivation for cocaine, as well as other cocaine-associated maladaptive behaviors in active cocaine users. This study will also provide basic science information about the orexinergic mechanisms underlying the pharmacodynamic effects of cocaine in humans. As such the outcomes will contribute to our understanding of the clinical neurobiology of cocaine use disorder. Overall, the proposed work seeks to expand the scope of current clinical neuroscience research on cocaine addiction by focusing on orexin, which has strong preclinical evidence supporting its critical role in addiction but remains unstudied in humans.

Conditions

• Cocaine Use Disorder

Interventions

Type	Name	Description
DRUG	Suvorexant	The pharmacodynamic effects of suvorexant maintenance will be determined.
DRUG	Cocaine	The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and suvorexant.
DRUG	Placebo oral capsule	The pharmacodynamic effects of placebo will be determined.

Timeline

• Start date: 2019-07-11
• Primary completion: 2022-04-30
• Completion: 2022-04-30
• First posted: 2019-05-06
• Last updated: 2023-02-09
• Results posted: 2023-02-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study