Pregnenolone to Reduce Stress-Induced Cocaine Craving and Improve Treatment Outcome

What is the purpose of this trial?

To test the preliminary efficacy of 200 mg and 400 mg of pregnenolone daily versus placebo in a dose-ranging study in individuals with cocaine use disorder. This proposal is a laboratory and treatment outcome study to examine the effects of pregnenolone on cocaine craving, mood and neurobiological reactivity to brief exposure to stress, drug cues and neutral situations in a sample of individuals with cocaine use disorder. We hypothesize that pregnenolone will be beneficial for reduction in stress and drug cue induced craving and related arousal. In a sample of 80 men and women with cocaine use disorder, we propose to examine (a) differences in measures of cocaine craving, emotion state, hypothalamic-pituitary-adrenal (HPA) activation, physiological arousal and plasma catecholamine response to stress imagery and to drug cue imagery as compared to neutral imagery; (b) reduction in cocaine abstinence symptoms; and (c) improvement in cocaine treatment outcomes as measured by increasing abstinence, reduction in cocaine use and increased treatment attendance and (d) sex differences in all of these outcomes.

Participation Guidelines

Ages: 18 years and older

Gender: Both

Yale University School of Medicine

Start Date: 07/21/2016

End Date: 07/31/2021

Last Updated: 02/22/2018

Study HIC#: 1603017466

Get Involved

For more information about this study, contact:
Arielle Rabinowitz
+1 203-737-8099

If you would prefer to contact a member of the Help us Discover team about this trial and other similar trials, please email or call 1-877-978-8348.

Trial Image


Verica Milivojevic

Principal Investigator