Early Phase 1 N=8 Randomized Triple-blind Basic Science

Suvorexant and Cocaine

Cocaine Use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT03937986 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2023

Primary outcome: Primary: Reinforcing Effects of Cocaine — 1.3; 5.0; 8.3; 0 Number of Cocaine Choices

Study Design & Population

Study type: Interventional
Phase: Early Phase 1
Interventions: Suvorexant (Drug); Cocaine (Drug); Placebo oral capsule (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: William Stoops
Primary completion: Apr 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Reinforcing Effects of Cocaine	1.3; 5.0; 8.3; 0; 3.7; 8.4	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03937986). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.