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NCT00632099 · ClinicalTrials.gov registry record · Phase 2
Progesterone Treatment for Cocaine-dependent Women: A Pilot Study
A Phase 2 study, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 21
- Enrollment target
NCT00632099 is a Phase 2 study that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 21 participants.
The verdict
NCT00632099, a Phase 2 study, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 21 participants
- Enrollment target
Study Summary
The purpose of this pilot treatment trial is to evaluate the efficacy of oral micronized PROG in cocaine-dependent women. Since we have shown (Evans \& Foltin, 2006) that oral micronized PROG attenuates the positive subjective effects of smoked cocaine in females, but not in males, and we have preliminary data indicating that oral micronized PROG also reduces smoked cocaine self-administration in the laboratory, PROG appears to be an ideal potential candidate medication to evaluate in cocaine-dependent women. Prior to randomization to treatment, women will reside inpatient for one week to ensure cocaine abstinence since one of the primary outcome measures will be time to cocaine relapse.
Interventions
- DRUG Placebo
- DRUG Oral micronized progesterone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2008-02 |
| Est. Completion | 2012-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00632099
The ClinicalTrials.gov registry entry for NCT00632099 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is New York State Psychiatric Institute, which has 364 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00632099 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00632099 about?
NCT00632099 is a clinical study titled "Progesterone Treatment for Cocaine-dependent Women: A Pilot Study". The purpose of this pilot treatment trial is to evaluate the efficacy of oral micronized PROG in cocaine-dependent women. Since we have shown (Evans \& Foltin, 2006) that oral micronized PROG attenuates the positive subjective effects of smoked cocaine in females, but not in males, and we have preli...
What is the current status of trial NCT00632099?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 21 participants. The study started on 2008-02. Estimated completion is 2012-09.
What interventions are being tested in trial NCT00632099?
The interventions under investigation include: Placebo (DRUG), Oral micronized progesterone (DRUG).
Who is sponsoring clinical trial NCT00632099?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
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