Tobacco Use Disorder Clinical Trial
Official title:
Progesterone and the Effects of Nicotine
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.
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" sensation, followed by a feeling of relaxation. Such positive reinforcement factors,
combined with nicotine cravings, make it difficult to stop the use of nicotine products. Past
research has suggested that women may experience fewer nicotine cravings and may be less
affected by smoking's positive reinforcement factors when compared to men. Fluctuations in
levels of the female hormones estradiol and progesterone during menstruation may play a role
in determining how women are affected by nicotine. The purpose of this study is to examine
the effects of a controlled oral dose of progesterone on smoking behavior, nicotine
withdrawal symptoms, and nicotine-related positive reinforcement factors in nicotine
dependent males and females.
In this 4-day study, participants will be randomly assigned to receive a daily dose of 200 mg
of progesterone, 400 mg of progesterone, or placebo. All participants will abstain from
smoking for Days 1 through 3. On Day 4, participants will take part in a smoking session,
during which their smoking habits, including the number of puffs, duration of puffs, and
number of cigarettes smoked, will be measured. Outcome measurements will include self-reports
of cravings; carbon monoxide monitoring; and standardized questionnaires to assess nicotine
withdrawal symptoms.
This study has been completed with 35 men and 30 women. With the final women completing in
March of 2008. This protocol is complete and has been published.
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