Clinical trial NCT00625131
Conditions: Stress Disorders, Posttraumatic Tobacco Use Disorder
Keywords: Stress Disorders, Posttraumatic Tobacco Use Disorder
Sponsor: US Department of Veterans Affairs
Start date: 2008-05-01; Completion date: 2013-03-01
Enrollment: 87 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief 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.

Arms: arm 1: Transdermal nicotine patch arm 2: Transdermal placebo patch
Interventions: intervention 1: Nicotine intervention 2: Cognitive Behavioral Therapy for Smoking Cessation intervention 3: Bupropion Sustained Release (SR) intervention 4: Placebo patch
Intervention descriptions: intervention 1: Delivered through transdermal nicotine patch intervention 2: Manualized protocol for CBT in smoking cessation intervention 3: Antidepressant intervention 4: Pre-treatment placebo transdermal patch

Protocol documents: