Effect of Progesterone on Smoking Behavior in Male and Female Smokers

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mehmet Sofuoglu, Yale University
ClinicalTrials.gov Identifier:
NCT00271206
First received: December 28, 2005
Last updated: July 24, 2012
Last verified: July 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Progesterone and the Effects of Nicotine

Resource links provided by NLM:


Further study details as provided by Yale University:

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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Connecticut
VA Connecticut Health Care System
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Investigators
Principal Investigator: Mehmet Sofuoglu, PhD Yale University, Department of Psychiatry
  More Information

No publications provided

Responsible Party: Mehmet Sofuoglu, Principle Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00271206     History of Changes
Other Study ID Numbers: R01 DA014537, R01DA014537, DPMC
Study First Received: December 28, 2005
Last Updated: July 24, 2012
Health Authority: United States: Federal Government

Keywords provided by Yale University:
Nicotine Dependence
Tobacco Dependence

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014