CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 8 enrolled
Drug / intervention
Suvorexant +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03937986
NCT03937986Early Ph 1Completed

Influence of Orexin Antagonism on Motivation for Cocaine

William Stoops·interventional·Posted May 6, 2019·Updated Feb 9, 2023

In Brief

A Early Phase 1 clinical trial evaluating Suvorexant, Cocaine, and 1 other intervention for Cocaine Use Disorder. Completed, enrolled 8 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Early Ph 1CompletedFinished
2020202120222023202420252026
First PostedMay 6, 2019
Enrollment StartJul 11, 2019
Primary CompletionApr 30, 2022
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 7.2 years ago

Interventions

Suvorexantdrug

The pharmacodynamic effects of suvorexant maintenance will be determined.

Cocainedrug

The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and suvorexant.

Placebo oral capsuledrug

The pharmacodynamic effects of placebo will be determined.