Nicotine Patch Pretreatment for Smoking Cessation in PTSD
Condition: Stress Disorders, Posttraumatic; Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study seeks to evaluate the relationship between PTSD, abstinence, and factors
      associated with relapse in the context of a randomized, clinical smoking cessation trial.
    

Detailed description: 
      Smokers with PTSD will be randomly assigned to 1 of 2 pre-cessation patch therapy conditions
      (active patch versus placebo patch) for three weeks before a target quit-smoking date. All
      participants to will receive bupropion beginning 1 week prior to their quit day, given that
      they are medically eligible to be prescribed bupropion. All participants will receive a two
      session brief cognitive-behavioral therapy (CBT) session and will begin standard nicotine
      replacement therapy (NRT) on their quit day. PTSD symptoms, mood, and smoking craving will be
      carefully evaluated throughout the study using electronic diary assessments on personal
      digital assistants (PDA). Specifically, participants will carefully monitor their symptoms,
      mood, craving, and use of cigarettes using electronic diaries for one week prior to the
      pre-cessation period, during the 3-week pre-cessation treatment period, and 6 weeks post quit
      date. Since no previous study has examined factors associated with smoking abstinence
      following treatment among PTSD smokers10, predictors of treatment response will be examined.
      The study is designed to address the following items:

      Specific Aim 1: To evaluate whether supplemental nicotine administration (i.e., pre-cessation
      treatment with nicotine patch and bupropion) will result in improved quit rates among smokers
      with PTSD.

      Hypothesis 1.1 Supplemental nicotine administration during the pre-cessation period will
      result in improved quit rates in the first quit week over the placebo patch condition.

      Specific Aim 2: To utilize electronic diary assessment of PTSD symptoms, mood, smoking
      craving, and smoking during baseline, pretreatment, and quit periods to evaluate potential
      mechanisms of how pretreatment with the nicotine patch may increase abstinence rates.

      Hypothesis 2.1 Supplemental nicotine administration will decrease craving for cigarettes
      during the 2 week pretreatment period as compared to the placebo patch condition.

      Hypothesis 2.2 Supplemental nicotine administration will decrease the perceived improvement
      in mood and PTSD symptoms associated with smoking behavior, i.e., symptom relief from ad lib
      smoking a cigarette will be reduced during supplemental nicotine administration as compared
      to the placebo patch condition.

      Specific Aim 3: To investigate potential predictors of smoking abstinence and relapse
      associated with individual differences in affective style including anxiety sensitivity,
      measures of distress tolerance, and self-efficacy.

      Hypothesis 3.1 Increased anxiety sensitivity will be predictive of shorter abstinence from
      smoking.

      Hypothesis 3.2 Decreased distress tolerance will be predictive of shorter abstinence.

      Hypothesis 3.3 Lower self-efficacy for smoking abstinence will be predictive of shorter
      abstinence.

      Hypothesis 3.4 Increased PTSD symptoms severity and negative affect following the quit date
      will be associated with shorter abstinence.
    

Intervention name(s): Nicotine; Cognitive Behavioral Therapy for Smoking Cessation; Bupropion Sustained Release (SR); Placebo patch
Intervention type(s): Drug; Behavioral; Drug; Drug
Intervention description(s): Delivered through transdermal nicotine patch; Manualized protocol for CBT in smoking cessation; Antidepressant; Pre-treatment placebo transdermal patch
Other intervention name(s): CBT; Zyban, Wellbutrin
Intervention MeSH terms: Bupropion; Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Stress Disorders, Posttraumatic; Tobacco Use Disorder