CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 58 enrolled
Drug / intervention
Pregnenolone (PREG) +1 moredrug
Likely dose
Pregnenolone (PREG) 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03953612
NCT03953612Early Ph 1Completed
CompareCT.gov

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

Yale University·interventional·Posted May 16, 2019·Updated Jul 3, 2024

In Brief

A Early Phase 1 clinical trial evaluating Pregnenolone (PREG) and Placebos for Cocaine-Related Disorders. Completed, enrolled 58 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCocaine-Related Disorders
CountriesUnited States
CollaboratorsNational Institute on Drug Abuse (NIDA)

Timeline

Early Ph 1CompletedFinished
20192020202120222023202420252026
First PostedMay 16, 2019
Enrollment StartMar 12, 2019
Primary CompletionMay 8, 2023
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 7.1 years ago

Interventions

Pregnenolone (PREG)drug

2 doses of PREG (300 or 500 mg/day)

Placebosdrug

placebo