Clinical trial NCT01055886: Supplemental Nicotine Administration for Smoking Cessation in Posttraumatic Stress Disorder (PTSD)
Official title: Supplemental Nicotine Administration for Smoking Cessation in PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Keywords: PTSD
smoking cessation
nicotine patch
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2010-01-26
Enrollment: 69
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Participants Self-reporting Abstinence During 6 Weeks Post Quit
timeFrame: 6 weeks post-quit (from quit date to Session 12); evaluated weekly from Session 7 to Session 12
Secondary outcomes:
measure: Abstinence as Measured by Exhaled Carbon Monoxide (CO)
timeFrame: Session 12, 6 weeks post-quit
Other outcomes:
measure: Diary Ratings of Cravings
timeFrame: During pre-quit period; two weeks
Locations:
city: Durham
country: United States
facility: VA Medical Center
state: North Carolina
Study officials:
affiliation: VA Medical Center; Duke University Medical Center
name: Patrick S. Calhoun, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: