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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

University of Minnesota

Minneapolis, Minnesota, United States, 55455