Status:
COMPLETED
Progesterone Treatment in Female Smokers - 12
Lead Sponsor:
National Institute on Drug Abuse (NIDA)
Collaborating Sponsors:
University of Minnesota
Conditions:
Tobacco Use Disorder
Eligibility:
FEMALE
21-45 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to investigate progesterone effects in female smokers
Detailed Description
Limited research has been done on the effects of gender and menstrual cycle in response to drugs of abuse in humans. The main goal of this pilot study is to investigate the safety and tolerability of ...
Eligibility Criteria
Inclusion Criteria:
Female subjects aged 21-45 years with a smoking history of at least 20 cigarettes daily for at least 1 year. In good health as verified by medical history, screening examination, and screening laboratory tests. Not pregnant as determined by pregnancy screening nor breast feeding, and using acceptable birth control methods other than hormonal contraceptives.
Exclusion Criteria:
History of heart disease, peripheral vascular disease, COPD, liver diseases, abnormal vaginal bleeding, suspected or known breast malignancy, or any other medical condition which physician investigator deems inappropriate for subject participation. Use of regular psychotropic medication (antidepressants, antipsychotics, or anxiolytics) and recent psychiatric history. Amenorrhea. Current use of oral or other types of hormonal contraceptives. Abuse of alcohol or any other recreational or prescription drug. Regular use of any other tobacco products, including smokeless tobacco and nicotine products. Known allergy to progesterone or peanuts.
Key Trial Info
Start Date :
April 1 1999
Trial Type :
INTERVENTIONAL
End Date :
December 1 2001
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00000295
Start Date
April 1 1999
End Date
December 1 2001
Last Update
January 12 2017
Active Locations (1)
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1
University of Minnesota
Minneapolis, Minnesota, United States, 55455