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Effect of Progesterone on Smoking Behavior in Male and Female Smokers

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00271206
First Posted: December 30, 2005
Last Update Posted: July 25, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
  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 Drug: sugar pill Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Progesterone and the Effects of Nicotine

Resource links provided by NLM:


Further study details as provided by Mehmet Sofuoglu, Yale University:

Primary Outcome Measures:
  • Smoking topography; measured by carbon monoxide levels and self-report at Day 4 [ Time Frame: 4 years anticipated ]
  • Nicotine withdrawal symptoms; measured by the Minnesota Nicotine Withdrawal Scale at Day 4 [ Time Frame: Anticipated 4 year study ]

Enrollment: 65
Study Start Date: September 2004
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Progesterone
200 mg to 400mg of progesterone
Drug: Progesterone
compared to placebo
Placebo Comparator: Sugar Pill
Will mirror active medication
Drug: sugar pill
Compared to progesterone

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. This protocol is complete and has been published.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00271206


Locations
United States, Connecticut
VA Connecticut Health Care System
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
National Institute on Drug Abuse (NIDA)
Investigators
Principal Investigator: Mehmet Sofuoglu, PhD Yale University, Department of Psychiatry
  More Information

Responsible Party: Mehmet Sofuoglu, Principle Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00271206     History of Changes
Other Study ID Numbers: R01DA014537 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
First Submitted: December 28, 2005
First Posted: December 30, 2005
Last Update Posted: July 25, 2012
Last Verified: July 2012

Keywords provided by Mehmet Sofuoglu, Yale University:
Nicotine Dependence
Tobacco Dependence

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Nicotine
Progesterone
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists