Effect of Progesterone on Smoking Behavior in Male and Female Smokers

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

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 this study is to examine the effects of progesterone on smoking behavior, nicotine withdrawal symptoms, and the reinforcing effects of smoking in men and women addicted to nicotine.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: National Institute on Drug Abuse (NIDA)
• Treatments: Nicotine; Progesterone

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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