Effect of Progesterone on Smoking Behavior in Male and Female Smokers

NCT ID: NCT00271206

Last Updated: 2020-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-09-30
• Study Completion Date: 2008-09-30

Brief Summary

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.

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.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Progesterone

200 mg to 400mg of progesterone

Group Type: ACTIVE_COMPARATOR

Progesterone

Intervention Type: DRUG

compared to placebo

Sugar Pill

Will mirror active medication

Group Type: PLACEBO_COMPARATOR

sugar pill

Intervention Type: DRUG

Compared to progesterone

Interventions

Progesterone

compared to placebo

Intervention Type: DRUG

sugar pill

Compared to progesterone

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mehmet Sofuoglu, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University, Department of Psychiatry

Locations

VA Connecticut Health Care System

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

R01DA014537

Identifier Type: NIH

Identifier Source: secondary_id

View Link

DPMC

Identifier Type: OTHER

Identifier Source: secondary_id

0407026935

Identifier Type: -

Identifier Source: org_study_id