Tobacco Cessation in Postmenopausal Women (Part I) - 1

Tobacco Use Disorder Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00061061
• Other study ID #: NIDA-08075-1
• Secondary ID: R01DA008075-01
• Status: Completed
• Phase: Phase 4
• First received: May 21, 2003
• Last updated: December 1, 2015
• Start date: March 1997
• Est. completion date: March 2003

Study information

• Verified date: December 2015
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2003
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 79 Years

Eligibility

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.

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Behavioral:
• Behavior Therapy

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking Cessation Outcomes		3 months	No