Suvorexant and Cocaine

Overview

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.

Full Title of Study: “Influence of Orexin Antagonism on Motivation for Cocaine”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: Triple (Participant, Care Provider, Outcomes Assessor)
  • Study Primary Completion Date: April 30, 2022

Interventions

  • 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.

Arms, Groups and Cohorts

  • Placebo Comparator: Placebo
    • Subjects will be maintained on oral placebo. Cocaine will be administered acutely during placebo maintenance. Placebo will be administered acutely during placebo maintenance.
  • Experimental: Suvorexant Dose 1
    • 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.
  • Experimental: Suvorexant Dose 2
    • 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.
  • Experimental: Suvorexant Dose 3
    • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • William Stoops
  • Collaborator
    • National Institute on Drug Abuse (NIDA)
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: William Stoops, Professor – University of Kentucky
  • Overall Official(s)
    • William W Stoops, PhD, Principal Investigator, University of Kentucky

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