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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 55 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

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

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Basic Science
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • 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.
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.
  • 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.
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.
  • 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.
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.
  • 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.

Recruiting Locations

UK Center for Clinical and Translational Science and nearby locations

University of Kentucky
Lexington, Kentucky 40507
Contact:
William W Stoops
859-257-5388
william.stoops@uky.edu

More Details

NCT ID
NCT03937986
Status
Recruiting
Sponsor
William Stoops

Study Contact

William W Stoops, PhD
8592575388
william.stoops@uky.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.