Status:
COMPLETED
Effect of Progesterone on Smoking Behavior in Male and Female Smokers
Lead Sponsor:
Yale University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
Tobacco Use Disorder
Eligibility:
All Genders
18-40 years
Phase:
PHASE1
Brief Summary
Past research on nicotine addiction has shown that changes in estradiol and progesterone hormone levels during menstruation may cause women to respond differently than men to nicotine. The purpose of ...
Detailed Description
Nicotine addiction is a serious health problem. Almost 35 million people in the United States try to quit smoking each year, but less than 7 percent are successful. Many smokers report a "high" sensat...
Eligibility Criteria
Inclusion
- History of smoking 10-25 cigarettes daily for the past 12 months
- Score of at least 5 on the Fagerström Nicotine Tolerance Questionnaire
- Carbon monoxide level greater than 10 ppm
- Body mass index between 19 to 36
- Currently in good health, as determined by medical history, screening examination, and laboratory tests
- If female, regular menstrual cycle every 25 to 35 days
- If female, willing to use non-hormonal contraception throughout the study
Exclusion
- Seeking treatment for nicotine dependence
- History of major medical illness, including liver disease; abnormal vaginal bleeding; suspected or known tumors; thrombophlebitis; deep vein thrombosis; pulmonary embolus; clotting or bleeding disorders; heart disease; diabetes; stroke; or other medical conditions that are considered unsafe for study participants by the investigator
- Regular use of psychotropic medication (antidepressants, antipsychotics, or anxiolytics)
- Recent diagnosis and treatment for Axis I disorders, including major depression, bipolar affective disorder, schizophrenia, or panic disorder
- Currently abusing alcohol or other recreational or prescription drugs
- Current use of any tobacco products other than cigarettes, including smokeless tobacco and nicotine products
- Known allergy to progesterone
- Known allergy to peanuts
- If female, amenorrhea
- Pregnant or breastfeeding
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2008
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00271206
Start Date
September 1 2004
End Date
September 1 2008
Last Update
April 2 2020
Active Locations (1)
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1
VA Connecticut Health Care System
New Haven, Connecticut, United States, 06519