Suvorexant and Cocaine

Cocaine Use Disorder Clinical Trial

Official title:

Influence of Orexin Antagonism on Motivation for Cocaine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03937986
• Other study ID #: BED IN 39
• Secondary ID: R01DA048617
• Status: Completed
• Phase: Early Phase 1
• Start date: July 11, 2019
• Est. completion date: April 30, 2022

Study information

• Verified date: February 2023
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: April 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Use Disorder

Intervention

Drug:
• Suvorexant
The pharmacodynamic effects of suvorexant maintenance will be determined.
• Cocaine
The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and suvorexant.
• Placebo oral capsule
The pharmacodynamic effects of placebo will be determined.

Locations

Country	Name	City	State
United States	University of Kentucky	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
William Stoops	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reinforcing Effects of Cocaine	Number of Times Subjects Choose Cocaine (Maximum of 10 Choices) Over Money	12 times over approximately 1 month inpatient admission.