Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Tobacco Cessation in Postmenopausal Women (Part I) - 1

This study has been completed.
Sponsor:
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00061061
First received: May 21, 2003
Last updated: November 3, 2005
Last verified: May 2003

May 21, 2003
November 3, 2005
March 1997
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00061061 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Tobacco Cessation in Postmenopausal Women (Part I) - 1
The Effects of ERT on Appetitive Behavior and Withdrawal in Short-Term Smoking Cessation Compared to Smoking Ad Lib in Postmenopausal Female Smokers.

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.

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.

Interventional
Phase 4
Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment
Tobacco Use Disorder
Behavioral: Behavior Therapy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
0
Not Provided
Not Provided

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.

Female
40 Years to 79 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00061061
NIDA-08075-1, R01-08075-1
Not Provided
Not Provided
National Institute on Drug Abuse (NIDA)
Not Provided
Principal Investigator: Sharon Allen, Ph.D., M.D. University of Minnesota - Clinical and Translational Science Institute
National Institute on Drug Abuse (NIDA)
May 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP