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Tobacco Cessation in Postmenopausal Women (Part I) - 1

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ClinicalTrials.gov Identifier: NCT00061061
Recruitment Status : Completed
First Posted : May 22, 2003
Last Update Posted : December 2, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this study is to evaluate the effects of ERT on appetitive behavior and withdrawal in short-term smoking cessation compared to smoking ad lib in postmenopausal female smokers.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Behavioral: Behavior Therapy Phase 4

Detailed Description:
Female subjects were screened and randomized. Following two weeks of medication monitoring, all participants continued smoking as usual for one week, at which time baseline measurements were taken. For the remaining two weeks (the experimental period), participants were randomized to a continued smoking or smoking abstinence condition. The abstinent group was provided with cessation counseling and monitored for abstinence. For all participants, data were collected during five clinic visits on all dependent measures: MNWS, QSU, Beck Depression Inventory (BDI), Profile of Mood States, Motor Speed Tasks and Reaction Time Tests. Question of interest was whether hormone replacement therapy would improve these dependent measures as manifested during short-term smoking cessation.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 0 participants
Allocation: Randomized
Masking: Double
Primary Purpose: Treatment
Official Title: The Effects of ERT on Appetitive Behavior and Withdrawal in Short-term Smoking Cessation Compared to Smoking ad Lib in Postmenopausal Female Smokers.
Study Start Date : March 1997
Primary Completion Date : March 2003
Study Completion Date : March 2003

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Smoking Cessation Outcomes [ Time Frame: 3 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Female smokers ages 40-79, smoking at least 15 cigarettes per day for at least one year, have natural menopause, have a transvaginal ultrasound to confirm loss of follicular activitiy, have a normal baseline mammogram, a normal chemistry at baseline, willing to take hormone replacement therapy for the duration of the study, normal thyroid function, and have a normal TSH.

Exclusion Criteria:

Women who have had formal dieting with or without pharmacological methods within the last three months; a weight change greater than or equal to 10 pounds within the last three months, BMI greater than or equal to 40, severe menopausal symptoms, active medical problems, alcohol or drug abuse, other forms of nicotine use.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00061061

United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute
National Institute on Drug Abuse (NIDA)
Principal Investigator: Sharon Allen, Ph.D., M.D. University of Minnesota - Clinical and Translational Science Institute
More Information

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT00061061     History of Changes
Other Study ID Numbers: NIDA-08075-1
R01DA008075-01 ( U.S. NIH Grant/Contract )
First Posted: May 22, 2003    Key Record Dates
Last Update Posted: December 2, 2015
Last Verified: December 2015

Keywords provided by University of Minnesota - Clinical and Translational Science Institute:
Tobacco Cessation
Postmenopausal Women

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders