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Progesterone for Cocaine-dependent Women
NCT00632099Phase 3
Key facts
- Status
- Completed
- Start
- Feb 2008
- Primary completion
- Sep 2012
- Countries
- 1
- Sponsor
- New York State Psychiatric Institute
- Modality
- Small Molecules
- Drugs
- progesterone
- Conditions
- cocaine dependence
01
Overview
Phase 3, randomised, double-blind trial in cocaine dependence comparing Placebo with Oral micronized progesterone (2 arms). Primary endpoints: Time to Cocaine Relapse at 10 weeks, Proportion of Patients Achieving at Least 2 Consecutive Weeks of Cocaine Abstinence at 10 weeks and 1 more. Started Feb 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Placebo
Matched placebo
Oral micronized progesterone
Oral micronized progesterone (up to 400 mg/day)
03
Who it enrols
Women aged 18-60 with current cocaine dependence, regular menstrual cycles, and no major psychiatric or medical contraindications.
04
Endpoints
Primary
Time to Cocaine Relapse
Proportion of Patients Achieving at Least 2 Consecutive Weeks of Cocaine Abstinence
Proportion of Cocaine-Negative Urines
Secondary
Response to Laboratory Stressors
Treatment Retention
Clinical Global Inventory
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