A Randomized Clinical Trial of Nicotine Preloading for Smoking Cessation in People with Posttraumatic Stress Disorder

Abstract

Objective: The aim of this research was to determine whether augmenting standard smoking cessation treatment by wearing an active nicotine patch before the smoking quit date improves rates of smoking cessation in individuals with posttraumatic stress disorder (PTSD) and to explore mechanisms of treatment response such as decreased cigarette craving and symptom relief from smoking.

Methods: This was a double-blind parallel randomized controlled trial in 81 people with PTSD who smoked cigarettes. Participants were recruited from Veterans Affairs outpatient clinics and flyers in the community. Participants provided ecological momentary assessments (EMAs) of PTSD symptoms, smoking withdrawal symptoms, and cravings before and after smoking a cigarette during one week of ad lib smoking and then three weeks of either a nicotine patch (n = 37) or placebo patch (n = 44) preceding the quit date. All participants received standard pharmacotherapy and behavioral treatment for smoking cessation after the quit date. To test the efficacy of nicotine patch preloading for engaging proposed treatment targets during the pre-quit phases, we used multilevel models to compare post-smoking changes in symptoms and cravings during the preloading phases to post-smoking changes reported during the ad lib smoking phase.

Results: There was no significant difference in quit rates across the two conditions on the primary outcome of seven-day point prevalence smoking abstinence bioverified with breath carbon monoxide at six weeks post-quit date. In a multivariable multilevel model pre- to post-cigarette changes in PTSD symptom clusters, smoking withdrawal symptoms, and cravings, there was a significant interaction between treatment phase and condition. Relative to participants in the placebo condition, participants in the nicotine patch condition experienced diminished relief from PTSD reexperiencing symptoms, smoking withdrawal symptoms, and cigarette craving after smoking a cigarette.

Conclusions: Relative to placebo patch preloading, nicotine patch preloading diminished the reinforcing effects of smoking cigarettes. However, the low quit rates in both conditions suggest that nicotine patch preloading is not a sufficiently intensive treatment for achieving smoking cessation in people with PTSD.

Trial registration: clinicaltrials.gov: NCT00625131.

Keywords: Ecological momentary assessment; nicotine replacement therapy; posttraumatic stress disorder; smoking cessation; tobacco.

Conflict of interest statement

Conflict of Interest

The authors have no conflicts of interest to disclose.

Figures

Figure 1

CONSORT Trial Flow Diagram

Figure 2

Study recruitment, screening, and data collection timeline. Notes: Durations for each phase were standardized across participants so that phases had the same durations across participants. Ad lib = Latin phrase that means “as often as desired.” EMA = ecological momentary assessment. mg = milligrams.

Figure 3

Mean cigarettes smoked per day by pre-quit phase and treatment condition. Cigarettes per day are drawn exclusively from random alarm ecological momentary assessments. Notes: Ad lib = Latin phrase that means “as often as desired.” Bup = bupropion.

Figure 4

Post-cigarette change in PTSD Re-experiencing symptoms, withdrawal symptoms, and cigarette craving by treatment phase and condition. Notes: Notes: Re-Experiencing and Craving were measured by ecological momentary assessment on a 5-point scale ranging from 1 (“not at all”) to 5 (“extremely”). Withdrawal Symptoms were measured by ecological momentary assessment on a 5-point scale ranging from 0 (“none”) to 4 (“severe”). Negative scores indicate drop in levels after smoking. Ad lib = Latin phrase that means “as often as desired.” Bup = bupropion.