The Gender-Sex Hormone Interface With Craving & Stress-Related Changes in Smoking

Despite considerable advances in treatment development, cigarette smoking remains the leading
cause of preventable death in the United States, and most smokers engaged in treatment are
unsuccessful in quitting. The burden of illness is disproportionately borne by female
smokers, who are less responsive to cessation interventions than males. The relationships
between stress, craving, and smoking behavior are recognized as key factors underlying gender
differences in nicotine dependence, but must be better understood and characterized to yield
avenues for interventions addressing this critical health disparity.

In prior and ongoing SCOR studies, our research team has demonstrated gender and menstrual
cycle/sex hormone influences on reactivity to laboratory-presented cues. Building from these
laboratory findings, we propose taking two important next steps: (1) evaluating the
experience of craving in the "real world" natural environment of female and male smokers, and
(2) examining the impact of a safe and novel pharmacological intervention (oxytocin) on
stress reactivity in female and male smokers.

If, as hypothesized, gender, sex hormones, and oxytocin administration influence the
relationships between stress, craving, and smoking behavior, the findings could substantially
address a key gender-related health disparity. Such knowledge could also inform the
development of gender-specific interventions to enhance female smokers' response to cessation
treatments. Therefore, the knowledge to be gained from the proposed study may yield
significant public health benefits.

Inclusion Criteria:

1. Females and males age 18 - 45 who smoke at least an average of 5 cigarettes per day
for at least past 6 months

2. Females must be post menarche and pre-menopausal, have a regular menstrual cycle
between 25 and 35 days, and, if recently pregnant, be at least three months
post-delivery/breast feeding

3. Participants must submit a carbon monoxide sample of ≥ 5 ppm at their screening visit

Exclusion Criteria:

1. Any serious or unstable medical or psychiatric disorder that may, in the judgment of
the study physician, interfere with study completion

2. Participants must not meet criteria for PTSD

3. Any medication (e.g., propranolol) that may interfere with psychophysiological (e.g.,
heart rate) monitoring

4. Current substance dependence other than nicotine and caffeine use, in the past month

5. Use of other tobacco products

6. Females must not be pregnant, breast feeding, status post hysterectomy or bilateral
oophorectomy, or taking birth control or hormone replacement medication that would
affect the menstrual cycle

7. Males must not be status post orchiectomy