PREG 300/500 mg for Cocaine Use Disorder

Phase-Based Progress Estimates
Yale Stress Center, New Haven, CTCocaine Use DisorderPREG 300/500 mg - Drug
18 - 60
All Sexes
What conditions do you have?

Study Summary

This trial will compare the effects of a daily dose of pregnenolone (PREG) to a placebo (PLA) in individuals with cocaine use disorder (CUD).

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

10 Primary · 2 Secondary · Reporting Duration: at week 8

at week 8
Change from baseline Adverse Events
Week 2
Area under the curve (Pharmacokinetic Profile )
Blood pressure responses in the laboratory
Craving reactivity in the laboratory
Heart rate beats per minutes responses in the laboratory
Maximum Plasma Concentration (Cmax); Pharmacokinetic Profile
Plasma Half-Life (t1/2) of Pregnenolone
Plasma cortisol levels as a measure of stress response in the laboratory
Provoked cognitive flexibility
Provoked negative emotion and anxiety
weekly during 8 weeks
Cocaine use amount as secondary clinical outcome using Timeline Followback Substance Use Calendar.
Cocaine use as secondary clinical outcome using urine toxicology.

Trial Safety

Trial Design

2 Treatment Groups

patients receiving PREG
1 of 2
patients receiving placebo
1 of 2

Experimental Treatment

Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: PREG 300/500 mg · Has Placebo Group · Phase < 1

patients receiving PREG
Experimental Group · 1 Intervention: PREG 300/500 mg · Intervention Types: Drug
patients receiving placebo
PlaceboComparator Group · 1 Intervention: Placebos · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: at week 8

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,703 Previous Clinical Trials
21,174,749 Total Patients Enrolled
Verica Milivojevic, PhDPrincipal InvestigatorYale University

Eligibility Criteria

Age 18 - 60 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
New York50.0%
How old are they?
18 - 65100.0%
What site did they apply to?
Yale Stress Center100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria50.0%
Met criteria50.0%

How responsive is this trial?

Typically responds via

Frequently Asked Questions

Is this research project accepting participants who are over 35 years of age?

"This study is open to those who meet the age requisites of being 18 years or older and younger than 60." - Anonymous Online Contributor

Unverified Answer

Who is eligible to engage in this examination?

"This research project is accepting aproximately 60 participants that have cocaine addiction, and are aged between 18 to 60 years old." - Anonymous Online Contributor

Unverified Answer

What is the current enrollment size of this experiment?

"Affirmative. Evidenced by, this investigation is currently recruiting participants; the original post was published on March 12th 2019 and edited most recently on March 9th 2022. This trial requires 60 patients to be registered at one medical site." - Anonymous Online Contributor

Unverified Answer

Are volunteers sought for this research project?

"Per the information on, this study is actively seeking out participants having initially been posted on March 12th 2019 and being most recently updated on March 9th 2022." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.