Suvorexant and Cocaine

Early Phase 1

Completed

• Conditions: Cocaine Use Disorder
• Interventions: Drug: Cocaine; Drug: Suvorexant; Drug: Placebo oral capsule

• Registration Number: NCT03937986
• Lead Sponsor: William Stoops

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-02
• Study First Posted: 2019-05-06
• Study Start: 2019-07-11
• Primary Completion: 2022-04-30
• Study Completion: 2022-04-30
• Results First Submitted: 2023-01-11
• Results First Submitted QC: 2023-01-11
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Results First Posted: 2023-02-08
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• Recent cocaine use

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Cocaine	Subjects will be maintained on oral placebo. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Placebo	Placebo oral capsule	Subjects will be maintained on oral placebo. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
Suvorexant Dose 1	Suvorexant	Subjects will be maintained on oral suvorexant dose 1. Cocaine will be administered acutely during suvorexant dose 1 maintenance. Placebo will be administered acutely during suvorexant dose 1 maintenance.
Suvorexant Dose 1	Cocaine	Subjects will be maintained on oral suvorexant dose 1. Cocaine will be administered acutely during suvorexant dose 1 maintenance. Placebo will be administered acutely during suvorexant dose 1 maintenance.
Suvorexant Dose 2	Suvorexant	Subjects will be maintained on oral suvorexant dose 2. Cocaine will be administered acutely during suvorexant dose 2 maintenance. Placebo will be administered acutely during suvorexant dose 2 maintenance.
Suvorexant Dose 3	Cocaine	Subjects will be maintained on oral suvorexant dose 3. Cocaine will be administered acutely during suvorexant dose 3 maintenance. Placebo will be administered acutely during suvorexant dose 3 maintenance.
Suvorexant Dose 2	Cocaine	Subjects will be maintained on oral suvorexant dose 2. Cocaine will be administered acutely during suvorexant dose 2 maintenance. Placebo will be administered acutely during suvorexant dose 2 maintenance.
Suvorexant Dose 3	Suvorexant	Subjects will be maintained on oral suvorexant dose 3. Cocaine will be administered acutely during suvorexant dose 3 maintenance. Placebo will be administered acutely during suvorexant dose 3 maintenance.

Primary Outcome Measures

Name	Time	Method
Reinforcing Effects of Cocaine	12 times over approximately 1 month inpatient admission.	Number of Times Subjects Choose Cocaine (Maximum of 10 Choices) Over Money

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States