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OpenTrials
Completed

NCT Number: NCT03937986

Suvorexant and Cocaine

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.

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Key information

Conditions

Cocaine Use Disorder

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Kentucky

Lexington, Kentucky, 40507, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Recent cocaine use

Exclusion criteria

  • Abnormal screening outcome (e.g., ECG, blood chemistry result) that study physicians deem clinically significant
  • Current or past histories of substance abuse or dependence that are deemed by the study physicians to interfere with study completion
  • History of serious physical disease, current physical disease, impaired cardiovascular functioning, chronic obstructive pulmonary disease, history of seizure or current or past histories of serious psychiatric disorder that in the opinion of the study physician would interfere with study participation will be excluded from participation
  • Females not currently using effective birth control
  • Contraindications to cocaine, methylphenidate or duloxetine

Treatment and study plan

Suvorexant

Drug

The pharmacodynamic effects of suvorexant maintenance will be determined.

Cocaine

Drug

The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and suvorexant.

Placebo oral capsule

Drug

The pharmacodynamic effects of placebo will be determined.

Primary outcomes

  1. Reinforcing Effects of Cocaine

    Time frame: 12 times over approximately 1 month inpatient admission.

    Number of Times Subjects Choose Cocaine (Maximum of 10 Choices) Over Money

Sponsors and collaborators

Lead sponsor

William Stoops

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Influence of Orexin Antagonism on Motivation for Cocaine

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
May 6, 2019
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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