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NCT02187224 · ClinicalTrials.gov registry record · Phase 2
Progesterone Effect on Individuals Diagnoses With AD and PTSD.
A Phase 2 study, sponsored by Yale University.
- Completed
- Registry status
- Phase 2
- Development phase
- 13
- Enrollment target
NCT02187224: Completed Phase 2 study, sponsored by Yale University.
NCT02187224 is a Phase 2 study that has completed, run by Yale University. The registered enrollment target is 13 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02187224, a Phase 2 study, has completed, sponsored by Yale University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 13 participants
- Enrollment target
Study Summary
This is a randomized control trial with an anticipated 36 participants diagnosed with post-traumatic stress disorder (PTSD) and comorbid alcohol dependence. Participants will be randomized to receive either progesterone (200 mg. bid) or placebo in identical looking capsules for three days. One goal of this research study is to test if progesterone is more effective than placebo in reducing craving after exposure to trauma cues and alcohol cues in a laboratory paradigm among men and women with AD and PTSD. We hypothesize that progesterone in comparison to placebo will significantly reduce craving for alcohol in response to trauma cues alone and in combination with alcohol cues in individuals with AD and PTSD. A second goal is to examine if there are gender differences in progesterone effects on stress and alcohol cue-induced craving. We hypothesize that the effects of progesterone on stress and craving will be stronger in women than in men. Participants will be recruited primarily through advertisement, but also through the clinical facilities at the VA and from other collaborators.
Primary Outcome
Visual Analogue Scale of Craving (VASC) is a self-report rating scale using the Likert scale (0 Not at all carving alcohol - 10 Extremely carving alcohol)
Interventions
- DRUG Progesterone
- DRUG Placebo (for Progesterone)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 13 participants |
| Start Date | 2016-09-01 |
| Est. Completion | 2021-09-08 |
| Phase | Phase 2 |
What the finished NCT02187224 record still lists
NCT02187224 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 13 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 2 interventions - of which Progesterone is the first listed.
NCT02187224 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02187224 about?
NCT02187224 is a clinical study titled "Progesterone Effect on Individuals Diagnoses With AD and PTSD.". This is a randomized control trial with an anticipated 36 participants diagnosed with post-traumatic stress disorder (PTSD) and comorbid alcohol dependence. Participants will be randomized to receive either progesterone (200 mg. bid) or placebo in identical looking capsules for three days. One goal...
What is the current status of trial NCT02187224?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 13 participants. The study started on 2016-09-01. Estimated completion is 2021-09-08.
What interventions are being tested in trial NCT02187224?
The interventions under investigation include: Progesterone (DRUG), Placebo (for Progesterone) (DRUG).
Who is sponsoring clinical trial NCT02187224?
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 NCT02187224's enrollment target sits among peer trials
13 1947th of 2000 higher than 53 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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