NCT00218140

Brief Summary

Women typically have a more difficult time quitting smoking than men. Little research has been done to understand the differences between men and women that may cause this distinction. This study will assess whether the reduced effectiveness of nicotine replacement therapy in women is caused by gender differences in the withdrawal suppression induced by nicotine replacement therapy.

Trial Health

80
On Track

Trial Health Score

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

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

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Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
Last Updated

January 12, 2017

Status Verified

October 1, 2016

First QC Date

September 16, 2005

Last Update Submit

January 11, 2017

Conditions

Smoking CessationTobacco Use Disorder

Keywords

tobacco

Outcome Measures

Primary Outcomes (3)

  • Physiological measures

  • Tobacco withdrawal

  • Behavioral accuracy

Interventions

nicotine transdermal systemDRUG

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Smokes at least 15 cigarettes a day for at least 2 years prior to enrollment
  • Has an afternoon carbon monoxide level of at least 15 ppm
  • Agree to use an effective form of contraception for the duration of the study

You may not qualify if:

  • History of chronic health problems
  • History of psychiatric conditions
  • History of or active cardiovascular disease
  • History of or active high or low blood pressure
  • History of or active seizure condition
  • History of or active peptic ulcers
  • History of or active diabetes
  • Pregnant
  • Score of greater than 17 on the Beck Depression Inventory

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University

Richmond, Virginia, United States

Location

MeSH Terms

Conditions

Smoking CessationTobacco Use Disorder

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Thomas Eissenberg, Ph.D.

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 22, 2005

Study Completion

April 1, 2005

Last Updated

January 12, 2017

Record last verified: 2016-10

Locations

US(1)