Supplemental Nicotine Administration for Smoking Cessation in Posttraumatic Stress Disorder (PTSD)
Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
Summary
The investigators propose to evaluate the relationship between PTSD, mood, craving and
withdrawal symptoms and factors associated with relapse in the context of a randomized
clinical smoking cessation trial. The use of supplemental nicotine administration (SNA)
during a "pre-treatment" phase before a targeted quit date is an innovative development in
smoking cessation, and may be helpful in treating smokers with PTSD. The use of SNA 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 brief cognitive-behavioral therapy (CBT) and will begin standard
nicotine replacement therapy on their quit day. PTSD symptoms, mood, smoking craving and
withdrawal symptoms will be evaluated using electronic diary assessment for one week prior to
the pre-cessation period, during the 2-week pre-cessation period, and 6 weeks post quit date.
The study is designed to address the following aims:
Specific Aim 1: To examine the effects of SNA on PTSD symptoms, mood, craving and withdrawal
through electronic diary assessment.
Hypothesis 1.1. SNA will decrease craving for cigarettes during the 2 week pretreatment
period as compared to the placebo patch condition.
Hypothesis 1.2. SNA will decrease the perceived improvement in mood and PTSD symptoms
associated with smoking behavior.
Hypothesis 1.3. SNA during the pre-cessation period will result in a reduction of withdrawal
symptoms following the quit-date.
Specific Aim 2: To evaluate the effect of SNA on quit rates among smokers with PTSD.
Hypothesis 2. SNA during the pre-cessation period will result in improved quit rates Specific
Aim 3: To investigate potential predictors of relapse including PTSD symptom severity, mood,
anxiety sensitivity, distress tolerance, and self-efficacy.
Hypothesis 3.1 - 3.5 Increased PTSD symptom severity, increased baseline negative affect,
increased anxiety sensitivity, decreased distress tolerance, and lower self-efficacy each
will independently be associated with shorter abstinence from smoking.