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Pregnenolone for Cocaine Use Disorder

Phase < 1
Waitlist Available
Led By Verica Milivojevic, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up between weeks 2-3 of treatment
Awards & highlights

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).

Who is the study for?
This trial is for men and women aged 18-60 with a cocaine use disorder, confirmed by a positive urine test or reports from close contacts. Participants must be able to read English and give informed consent. It excludes those using opiates or certain psychoactive drugs, with psychotic disorders, significant medical conditions, pregnant/nursing women, or those not on birth control.Check my eligibility
What is being tested?
The study tests the effects of pregnenolone (PREG), at doses of 300mg and 500mg daily, against a placebo in individuals with cocaine use disorder. The goal is to understand how neuroactive steroids affect stress and drug cravings/usage in these individuals.See study design
What are the potential side effects?
While specific side effects are not listed for PREG in this context, common reactions may include headache, fatigue, irritability or other mood changes. As it's an investigational study, part of its purpose is to monitor any potential side effects.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~between weeks 2-3 of treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and between weeks 2-3 of treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Craving reactivity in the laboratory
Secondary outcome measures
Plasma cortisol levels as a measure of stress response in the laboratory
Pregnenolone levels
Provoked anxiety
Other outcome measures
Cocaine amount during trial assessed using Timeline Followback Substance Use Calendar and corroborated by self-report on daily smartphone monitoring.
Percent cocaine days

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: patients receiving PREGExperimental Treatment1 Intervention
Eligible participants will be randomly assigned to 2 doses of PREG (300/500 mg/day) over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for first two weeks and then outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient option where they will participate in the entire study outpatient at YSC.
Group II: patients receiving placeboPlacebo Group1 Intervention
Eligible participants will be randomly assigned to a placebo (PLA) treatment over 8 weeks with a) an inpatient-outpatient option where they will be admitted to the Clinical Neuroscience Research Unit (CNRU) at the Connecticut Mental Health Center (CMHC) for the first two weeks and then transition to outpatient at Yale Stress Center (YSC) for the remaining 6 weeks, or b) an outpatient only option where they will participate in the entire study outpatient at YSC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PREG 300/500 mg
2019
Completed Early Phase 1
~60

Find a Location

Who is running the clinical trial?

National Institute on Drug Abuse (NIDA)NIH
2,467 Previous Clinical Trials
2,619,065 Total Patients Enrolled
Yale UniversityLead Sponsor
1,848 Previous Clinical Trials
2,737,760 Total Patients Enrolled
Verica Milivojevic, PhDPrincipal InvestigatorYale University

Media Library

Placebos Clinical Trial Eligibility Overview. Trial Name: NCT03953612 — Phase < 1
Cocaine Use Disorder Research Study Groups: patients receiving placebo, patients receiving PREG
Cocaine Use Disorder Clinical Trial 2023: Placebos Highlights & Side Effects. Trial Name: NCT03953612 — Phase < 1
Placebos 2023 Treatment Timeline for Medical Study. Trial Name: NCT03953612 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

What is the current enrollment size of this experiment?

"Affirmative. Evidenced by clinicaltrials.gov, 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."

Answered by AI

Are volunteers sought for this research project?

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

Answered by AI

Who else is applying?

What state do they live in?
New York
Tennessee
How old are they?
18 - 65
What site did they apply to?
Yale Stress Center
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

How responsive is this trial?

Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders
2019. "The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03953612.
~10 spots leftby Apr 2025
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