Suvorexant and Cocaine
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
- Cocaine Use Disorder
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
Arm | Description | Assigned 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. |
|
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. |
|
Recruiting Locations
More Details
- NCT ID
- NCT03937986
- Status
- Completed
- Sponsor
- William Stoops