Status:
COMPLETED
Progesterone for the Treatment of Cocaine Dependence - 1
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Cocaine Abuse
Cocaine-Related Disorders
Eligibility:
All Genders
18-46 years
Phase:
NA
Brief Summary
Past research has demonstrated that cocaine dependent women experience less severe responses to cocaine during the luteal phase of the menstrual cycle, when estrogen and progesterone concentrations ar...
Detailed Description
Changes in ovarian hormones across the menstrual cycle impact responses to cocaine in women. Studies have shown that cocaine's effects are dampened during the luteal phase of the menstrual cycle, when...
Eligibility Criteria
Inclusion
- Smoked at least 1 gram of cocaine each week for the 6 months prior to study entry
- Agrees to use an adequate method of contraception for the duration of the study
- If female, current regular menses
Exclusion
- Major psychiatric illnesses, including psychotic mood and anxiety disorders
- Current dependence on alcohol or drugs other that cocaine or nicotine
- History of major medical illnesses, including liver disease, abnormal vaginal bleeding, suspected or known breast cancer, thrombophlebitis, or other medical conditions
- Current use of oral contraceptives or other types of hormonal contraceptives
- Amenorrhea
- Currently on parole or probation
- Received treatment for chemical dependency within the 6 months prior to study entry
- Known allergy to progesterone or peanuts
Key Trial Info
Start Date :
July 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2008
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00218257
Start Date
July 1 2002
End Date
June 30 2008
Last Update
October 8 2020
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455