This trial is active, not recruiting.

Condition smoking cessation
Treatments nicotine patch, placebo patch
Sponsor Duke University
Start date November 2009
End date December 2014
Trial size 81 participants
Trial identifier NCT01055886, Pro00013158


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose treatment
(Active Comparator)
Nicotine patch given pre-quit attempt at weeks 4 through 6
nicotine patch Nicoderm, Habitrol
Nicotine patch, 7-21 mg.
(Placebo Comparator)
placebo patch given pre-quit from weeks 4 through 6
placebo patch
placebo patch used from weeks 4-6

Primary Outcomes

participant self-report of smoking cessation
time frame: weeks 7-12; 6 months

Secondary Outcomes

exhaled carbon monoxide
time frame: weeks 7-12; 6 months

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - between ages of 18 and 70 - smoker who has smoked 10 or more cigarettes per day during past year - current PTSD - English speaker - study physician clearance Exclusion Criteria: - organic mental disorder, schizophrenia, current manic syndrome, lifetime but not current PTSD, or current substance abuse/dependence - pregnancy - unstable medications - myocardial infarction in past 6 months

Additional Information

Official title Supplemental Nicotine Administration for Smoking Cessation in PTSD
Principal investigator Patrick S. Calhoun, Ph.D.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by Duke University.