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The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders

Cocaine-Related Disorders Clinical Trial

Official title:
The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders

Clinical Trial Summary

To use pregnenolone (PREG; 300; 500mg) daily versus placebo (PLA) as a probe to assess the role of neuroactive steroids in individuals with cocaine use disorder (CUD).

Clinical Trial Description

This experimental study aims to examine the effects of PREG on a) repeated cocaine craving, mood and neurobiological reactivity to brief, guided imagery exposure to stress, drug cues and neutral situations in the laboratory and b) daily cocaine intake, craving, cognition and mood in men and women with CUD; and c) sex differences in all of these outcomes. The study's hypothesis is that PREG vs PLA will dose-specifically decrease stress-induced and drug-cue induced cocaine craving, improve mood and cognitive performance, and normalize hypothalamic pituitary adrenal (HPA) axis response to stress and drug-cue imagery, and reduce cocaine intake and craving in daily life in individuals with CUD. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03953612
Study type Interventional
Source Yale University
Contact
Status Completed
Phase Early Phase 1
Start date March 12, 2019
Completion date May 8, 2023
View Details
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