NCT00135746

Brief Summary

Treatment studies have demonstrated that current smoking cessation techniques are less effective for women. The purpose of this study is to determine the role that gender plays on the effectiveness of nicotine replacement therapy. This may lead to improved cessation interventions for all smokers, particularly women.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2004

Typical duration for not_applicable

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

May 1, 2004

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 26, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

January 12, 2017

Status Verified

October 1, 2015

Enrollment Period

3 years

First QC Date

August 23, 2005

Last Update Submit

January 11, 2017

Conditions

Tobacco Use Disorder

Keywords

tobacco

Outcome Measures

Primary Outcomes (5)

  • Subjective effects

  • Cognitive performance

  • Physiologic measures

  • Smoking Behavior

  • Plasma Nicotine

Interventions

nicotine transdermal systemDRUG

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Daily cigarette use of 15 or more cigarettes for at least 2 years
  • Screening CO level of or greater than 15 ppm
  • Normal or corrected-to-normal vision
  • Willing to abstain from tobacco products for 8 or more hours prior to testing

You may not qualify if:

  • History of chronic health problems or psychiatric conditions
  • History of cardiovascular disease, low or high blood pressure, seizures, head injuries requiring hospital care, peptic ulcer, or diabetes
  • Pregnancy (tested by urinalysis)
  • Scores greater than 17 on the Beck Depression Inventory
  • Lack of a high school degree or GED

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Behavioral Pharmacolgy Research Laboratory

Richmond, Virginia, 23298 0205, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Thomas Eissenberg, Ph.D.

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
NIH

Study Record Dates

First Submitted

August 23, 2005

First Posted

August 26, 2005

Study Start

May 1, 2004

Primary Completion

May 1, 2007

Study Completion

June 1, 2007

Last Updated

January 12, 2017

Record last verified: 2015-10

Locations

US(1)