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 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Supplemental Nicotine Administration for Smoking Cessation in PTSD|
- participant self-report of smoking cessation [ Time Frame: weeks 7-12; 6 months ] [ Designated as safety issue: No ]
- exhaled carbon monoxide [ Time Frame: weeks 7-12; 6 months ] [ Designated as safety issue: No ]
- Diary ratings [ Time Frame: During treatment period ] [ Designated as safety issue: No ]Participants will provide ecological momentary assessment of mood, cravings, and withdrawal symptoms on a daily basis during a period of the study.
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Nicotine Patch
Nicotine patch given pre-quit attempt at weeks 4 through 6
Drug: nicotine patch
Nicotine patch, 7-21 mg.
Other Name: Nicoderm, Habitrol
Placebo Comparator: placebo patch
placebo patch given pre-quit from weeks 4 through 6
Drug: placebo patch
placebo patch used from weeks 4-6
Please refer to this study by its ClinicalTrials.gov identifier: NCT01055886
|United States, North Carolina|
|VA Medical Center|
|Durham, North Carolina, United States, 27705|
|Principal Investigator:||Patrick S. Calhoun, Ph.D.||VA Medical Center; Duke University Medical Center|