Tobacco Cessation in Postmenopausal Women (Part I) - 1

December 1, 2015 updated by: University of Minnesota

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.

Study Overview

Status

Completed

Conditions

Tobacco Use Disorder

Intervention / Treatment

Behavioral: Behavior Therapy

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 Type

Interventional

Phase

Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Minnesota
  - Minneapolis, Minnesota, United States, 55455
    - University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Smoking Cessation Outcomes Time Frame: 3 months	3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Minnesota

Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator: Sharon Allen, Ph.D., M.D., University of Minnesota

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1997

Primary Completion (Actual)

March 1, 2003

Study Completion (Actual)