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Menstrual Cycle Effects on Smoking Cessation and Cue Reactivity

NCT00664755 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2018-05-24

Study results available
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Summary

This is a brief smoking cessation trial in women, comparing transdermal nicotine patch (TNP) versus varenicline.

Conditions

  • Nicotine Dependence

Interventions

DRUG

varenicline

Day -7 thru -5: 0.5mg QD Day -4 thru -1: 0.5mg BID Day 0 onward: 1.0mg BID Varenicline is taken for a duration of 4 weeks in this study.

DEVICE

transdermal nicotine patch

Weeks 0-3: 21mg patch Transdermal nicotine patch is used for a duration of 3 weeks in this study.

Sponsors & Collaborators

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Kevin Gray, MD · Medical University of South Carolina

  • Michael E Saladin, PhD · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00664755 on ClinicalTrials.gov