Supplemental Nicotine Administration for Smoking Cessation in Posttraumatic Stress Disorder (PTSD)

The investigators propose to evaluate the relationship between PTSD, mood, craving and
withdrawal symptoms as well as factors associated with relapse (i.e., treatment response) in
the context of a randomized clinical smoking cessation trial. The use of supplemental
nicotine administration during a "pre-treatment" phase before a targeted quit data is a
recent innovative development in smoking cessation therapy, and may be particularly helpful
in treating smokers with PTSD. The use of supplemental nicotine administration during ad lib
smoking for smokers with PTSD is predicted to reduce both the physiological and emotional
dependence on inhaled nicotine, thereby increasing the odds of successful smoking cessation.

Smokers with PTSD will be randomly assigned to 1 of 2 pre-cessation patch therapy conditions
(active patch versus placebo patch) for 2 weeks before a target quit-smoking date. All
participants will receive an integrated brief cognitive-behavioral therapy (CBT) and will
begin standard nicotine replacement therapy (NRT) on their quit day. PTSD symptoms, mood,
smoking craving and withdrawal symptoms will be carefully evaluated using electronic diary
assessment. Specifically, participants will carefully monitor their symptoms, mood, craving,
use of cigarettes, and withdrawal symptoms using electronic diaries for one week prior to
the pre-cessation period, during the 2-week pre-cessation period, and 6 weeks post quit
date. Since no previous study has examined factors associated with smoking abstinence
following treatment among PTSD smokers,12 predictors of treatment response will be examined.
The study is designed to address the following aims:

Specific Aim 1: To examine the effects of supplemental nicotine administration on PTSD
symptoms, mood, craving, and withdrawal through electronic diary assessment.

Hypothesis 1.1. Supplemental nicotine administration will decrease craving for cigarettes
during the 2 week pretreatment period as compared to the placebo patch condition.

Hypothesis 1.2. Supplemental nicotine administration will decrease the perceived improvement
in mood and PTSD symptoms associated with smoking behavior, i.e., smoking a cigarette will
be less reinforcing during supplemental nicotine administration compared to the placebo
patch condition.

Hypothesis 1.3. Supplemental nicotine administration during the pre-cessation period will
result in a reduction of withdrawal symptoms following the quit-date over the placebo patch
condition.

Specific Aim 2: To evaluate the effect of supplemental nicotine administration on quit rates
among smokers with PTSD.

Hypothesis 2. Supplemental nicotine administration during the pre-cessation period will
result in improved quit rates over the placebo patch condition

Specific Aim 3: To investigate potential predictors of relapse including individual
differences in affective style including PTSD symptom severity, baseline mood, anxiety
sensitivity, measures of distress tolerance, and self-efficacy.

Hypothesis 3.1 Increased PTSD symptom severity will be associated with shorter abstinence
from smoking.

Hypothesis 3.2 Increased baseline negative affect will be associated with shorter abstinence
from smoking.

Hypothesis 3.3 Increased anxiety sensitivity will be associated with shorter abstinence from
smoking.

Hypothesis 3.4. Decreased distress tolerance will be associated with shorter abstinence from
smoking.

Hypothesis 3.5. Lower self-efficacy for smoking abstinence will be associated with shorter
abstinence from smoking.