drugset
drugset / Trial / NCT03953612

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

NCT03953612 ↗

Phase 0 Completed 58 enrolled Yale University National Institute on Drug Abuse (NIDA) · collab
RandomizedParallel-groupSingle-blindTreatment

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).

Timeline

Start
2019-03-12
Primary completion
2023-05-08
Completion
2023-05-08

Outcome

Met primary endpoint

registry analysis (superiority test); PREG 300 mg/Day vs PREG 500 mg/Day vs Patients Receiving Placebo; p <.001; Mixed Models Analysis NCT03953612 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Pregnenolone Other / unclassified 300 mg —
Subject Pregnenolone Other / unclassified 500 mg —

Indications

substance-related disorder