Tobacco Cessation in Postmenopausal Women (Part I) - 1

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.

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.