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NCT03953612 · ClinicalTrials.gov registry record · Early Phase 1
The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders
A Early Phase 1 study, sponsored by Yale University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 58
- Enrollment target
NCT03953612: Completed Early Phase 1 study, sponsored by Yale University.
NCT03953612 is a Early Phase 1 study that has completed, run by Yale University. The registered enrollment target is 58 participants, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03953612, a Early Phase 1 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 58 participants
- Enrollment target
Study 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).
Primary Outcome
Cocaine craving assessed in a laboratory experiment with exposure to stress, cocaine cue and neutral control condition in those receiving PREG (300mg; 500mg) vs Placebo. Cocaine craving was assessed using the Cocaine Craving Questionnaire (CCQ), a brief 10-item self-report craving scale that ranges in mean score from 1 to 7, where a higher score indicates higher craving. Data presented here is craving change in stress relative to neutral and craving change in cue relative to neutral, where the p
Interventions
- DRUG Placebos
- DRUG Pregnenolone (PREG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 58 participants |
| Start Date | 2019-03-12 |
| Est. Completion | 2023-05-08 |
| Phase | Early Phase 1 |
What the finished NCT03953612 record still lists
NCT03953612 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 58 participants, a relatively small participant target, roughly in line with the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which Placebos is the first listed.
NCT03953612 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03953612 about?
NCT03953612 is a clinical study titled "The Role of Neuroactive Steroids in Stress, Drug Craving and Drug Use in Cocaine Use Disorders". 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).
What is the current status of trial NCT03953612?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 58 participants. The study started on 2019-03-12. Estimated completion is 2023-05-08.
What interventions are being tested in trial NCT03953612?
The interventions under investigation include: Placebos (DRUG), Pregnenolone (PREG) (DRUG).
Who is sponsoring clinical trial NCT03953612?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03953612's enrollment target sits among peer trials
58 441st of 2000 higher than 1,556 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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