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|
- Participants Self-reporting Abstinence During 6 Weeks Post Quit [ Time Frame: 6 weeks post-quit (from quit date to Session 12); evaluated weekly from Session 7 to Session 12 ] [ Designated as safety issue: No ]In the 6 week post-quit period, participants completed ecological momentary assessment (EMA), or diary, ratings of their smoking behavior. This outcome reflects the number of participants who reported not relapsing (i.e., smoking 7 days in a row) during the 6 weeks post-quit.
- Abstinence as Measured by Exhaled Carbon Monoxide (CO) [ Time Frame: Session 12, 6 weeks post-quit ] [ Designated as safety issue: No ]This outcome reflects the number of participants whose exhaled carbon monoxide (CO; a measure of smoking) indicated abstinence (i.e., 6 parts per million or less) at Session 12, which occurred six weeks post-quit.
- Diary Ratings of Cravings [ Time Frame: During pre-quit period; two weeks ] [ Designated as safety issue: No ]Participants provided (through ecological momentary assessment) ratings of their smoking craving. This outcome reflects differences between ad lib (or typical) smoking craving compared to smoking craving reported during the pre-quit period. Craving was reported from a single item "Please indicate your desire/craving to smoke," and answers were provided in a 5-point Likert scale where 1=no craving and 5=severe craving. Higher scores are presumed to be "worse" because they indicate increased craving, which is likely to lead to non-abstinence.
|Study Start Date:||November 2009|
|Study Completion Date:||November 2014|
|Primary Completion Date:||November 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|