NCT03953612

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 58 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Cocaine-Related Disorders

Interventions

Type	Name	Description
DRUG	Pregnenolone (PREG)	2 doses of PREG (300 or 500 mg/day)
DRUG	Placebos	placebo

Timeline

• Start date: 2019-03-12
• Primary completion: 2023-05-08
• Completion: 2023-05-08
• First posted: 2019-05-16
• Last updated: 2024-07-03
• Results posted: 2024-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study