Clinical trial NCT00625131: Nicotine Patch Pretreatment for Smoking Cessation in PTSD
Official title: Nicotine Patch Pre-treatment for Smoking Cessation in PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Stress Disorders, Posttraumatic
Tobacco Use Disorder
Keywords: Stress Disorders, Posttraumatic
Tobacco Use Disorder
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2008-02-28
Enrollment: 87
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: 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.

Eligibility criteria: Inclusion Criteria:

* Smokers who smoke 10 or more cigarettes per day in the past year;
* 18-80 years old;
* English speakers;
* medically stable;
* stable on current medication regimen

Exclusion Criteria:

* Pregnant women excluded;
* participants with organic mental disorder, schizophrenia, bipolar disorder, lifetime but not current PTSD, current substance abuse or dependence;
* medical conditions contraindicated with nicotine replacement therapy;
* use other forms of nicotine (cigars, nicotine gum, etc.)

Primary outcomes:
measure: Smoking Abstinence, Self-reported
timeFrame: Week prior to Session 12 at 6 weeks post-treatment
Secondary outcomes:
measure: Carbon Monoxide Monitoring
timeFrame: Session 12 (6 weeks post-treatment)
measure: Smoking Craving
timeFrame: Daily between visits 2-12
Other outcomes:
Locations:
city: Durham
country: United States
facility: VA Medical Center, Durham
state: North Carolina
Study officials:
affiliation: VA Medical Center, Durham
name: Jean C. Beckham, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dedert EA, Dennis PA, Calhoun PS, Dennis MF, Beckham JC. A Randomized Clinical Trial of Nicotine Preloading for Smoking Cessation in People with Posttraumatic Stress Disorder. J Dual Diagn. 2018 Jul-Sep;14(3):148-157. doi: 10.1080/15504263.2018.1468947. Epub 2018 Oct 10.