Effect of Progesterone on Smoking Behavior in Male and Female Smokers - Full Text View

Sponsored by:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00271206

Purpose

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.

Condition	Intervention	Phase
Tobacco Use Disorder	Drug: Progesterone	Phase I

MedlinePlus related topics: Smoking

Drug Information available for: Progesterone Nicotine polacrilex Nicotine tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Progesterone and the Effects of Nicotine

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

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 ]

Estimated Enrollment:	168
Study Start Date:	September 2004
Estimated Study Completion Date:	September 2008
Estimated Primary Completion Date:	June 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Progesterone will be given on the first day of menstruation for a duration of four days.

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" 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. Currently in Data Analysis phase

Eligibility

Ages Eligible for Study:	18 Years to 40 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00271206

Contacts

Contact: Lance Barnes

203-937-4823

lance.barnes@yale.edu

Locations

United States, Connecticut
VA Connecticut Health Care System	Recruiting
New Haven, Connecticut, United States, 06519
Contact: Lance Barnes 203-937-4823 lance.barnes@yale.edu
Principal Investigator: Mehmet Sofuoglu, PhD

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Mehmet Sofuoglu, PhD

Yale University, Department of Psychiatry

More Information

Responsible Party:	Yale University ( Mehmet Sofuoglu M.D., Ph.D. )
Study ID Numbers:	R01DA14537, DPMC
Study First Received:	December 28, 2005
Last Updated:	July 10, 2008
ClinicalTrials.gov Identifier:	NCT00271206
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Nicotine Dependence
Tobacco Dependence

Study placed in the following topic categories:

Nicotine polacrilex
Smoking
Progesterone
Nicotine

Mental Disorders
Tobacco Use Disorder
Substance-Related Disorders
Disorders of Environmental Origin

Additional relevant MeSH terms:

Progestins
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009