NCT00271206

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2004

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

December 28, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 30, 2005

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
Last Updated

April 2, 2020

Status Verified

March 1, 2020

Enrollment Period

4 years

First QC Date

December 28, 2005

Last Update Submit

March 31, 2020

Conditions

Tobacco Use Disorder

Keywords

Nicotine DependenceTobacco Dependence

Outcome Measures

Primary Outcomes (2)

  • Smoking topography; measured by carbon monoxide levels and self-report at Day 4

    4 years anticipated

  • Nicotine withdrawal symptoms; measured by the Minnesota Nicotine Withdrawal Scale at Day 4

    Anticipated 4 year study

Study Arms (2)

Progesterone

ACTIVE COMPARATOR

200 mg to 400mg of progesterone

Drug: Progesterone

Sugar Pill

PLACEBO COMPARATOR

Will mirror active medication

Drug: sugar pill

Interventions

ProgesteroneDRUG

compared to placebo

Progesterone
sugar pillDRUG

Compared to progesterone

Sugar Pill

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Health Care System

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

ProgesteroneSugars

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsCorpus Luteum HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsProgesterone CongenersGonadal Steroid HormonesCarbohydrates

Study Officials

  • Mehmet Sofuoglu, PhD

    Yale University, Department of Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2005

First Posted

December 30, 2005

Study Start

September 1, 2004

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

April 2, 2020

Record last verified: 2020-03

Locations

US(1)