Effect of Progesterone on Smoking Behavior in Male and Female Smokers
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Progesterone and the Effects of Nicotine|
- Smoking topography; measured by carbon monoxide levels and self-report at Day 4 [ Time Frame: 4 years anticipated ] [ Designated as safety issue: No ]
- Nicotine withdrawal symptoms; measured by the Minnesota Nicotine Withdrawal Scale at Day 4 [ Time Frame: Anticipated 4 year study ] [ Designated as safety issue: No ]
|Study Start Date:||September 2004|
|Study Completion Date:||September 2008|
|Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Active Comparator: Progesterone
200 mg to 400mg of progesterone
compared to placebo
Placebo Comparator: Sugar Pill
Will mirror active medication
Drug: sugar pill
Compared to progesterone
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00271206
|United States, Connecticut|
|VA Connecticut Health Care System|
|New Haven, Connecticut, United States, 06519|
|Principal Investigator:||Mehmet Sofuoglu, PhD||Yale University, Department of Psychiatry|