Peter S. Hendricks, Ph.D. - US grants

[unreadable] DESCRIPTION (provided by applicant): Cigarette smoking remains the single most preventable cause or morbidity and mortality in the United States, accounting for approximately 440,000 deaths per year. It is thus essential that researchers continue to investigate the factors relevant to the treatment of nicotine dependence. Drug-related expectancies represent the consequences that an individual expects from the use (or non-use) of any given substance. With respect to smoking, research has focused on smokers' expectancies for the use of cigarettes. These expectancies, as measured by the standard smoking expectancy questionnaires, are robust predictors of smoking motivation and behavior. However, no prior study has examined smokers' expectancies for the non-use of cigarettes. That is, no previous study has investigated the consequences that smokers expect when they quit smoking (that is, abstinence-related expectancies). However, these expectancies likely have considerable significance to the treatment of nicotine dependence. The primary goal of the current study is to examine smokers' expectancies for abstinence via the development of an abstinence-related expectancies questionnaire: the Smoking Abstinence Questionnaire (SAQ). An initial pool of SAQ items will be developed via reference to the literature, focus groups with current smokers, and expert panel review. A draft version of the SAQ will be administered to 500 current smokers and refined with the use of established psychometric procedures, including factor analysis. The SAQ's relationship to smoking-relevant variables will be examined, including its relationship to nicotine dependence, withdrawal, motivation to quit, abstinence self-efficacy, negative affect, and smoking expectancies. We hypothesize that the SAQ will have significant relationships with each of these variables, thereby providing evidence for its construct validity. The proposed study will provide valuable information regarding the process of quitting and important treatment-related process variables. Moreover, the development of the SAQ will allow for continued, systematic, research of the role of abstinence-related expectancies in the quitting process. Finally, this investigation may help inform smoking treatment. Thus, the current study will advance the development of nicotine dependence treatments. Relevance: No prior study has investigated the consequences that smokers anticipate when they quit smoking, although these expectancies likely have significance in the treatment of nicotine dependence. The primary goal of the current study is the development of an abstinence-related expectancies questionnaire. Thus, the current study will advance the development of nicotine dependence treatments. [unreadable] [unreadable] [unreadable]

DESCRIPTION (provided by applicant): Cigarette smoking remains the single most preventable cause of mortality and morbidity in the United States. Long-term abstinence rates for even the most rigorous of smoking cessation treatments range between 20 percent and 35 percent. It is therefore essential that research continue to investigate novel smoking cessation interventions. Considerable evidence suggests that withdrawal processes form the motivational basis for cigarette smoking and play a critical role in relapse to cigarette use. While withdrawal from nicotine, or pharmacologic withdrawal, may be limited to 10 days, withdrawal from the act of smoking, or behavioral withdrawal, may persist indefinitely. Accordingly, it has been suggested that smoking cessation interventions may be augmented by aiding smokers in the practice of withdrawal regulation strategies. The primary goal of this investigation is to pilot an in vivo early withdrawal exposure with withdrawal regulation training intervention for smoking cessation. Specific aims include: informing the feasibility of investigating the experimental intervention;determining the experimental treatment's potential efficacy;and investigating mediators and moderators of the experimental treatment. Participants will be adult smokers (N = 50) of at least 10 cigarettes per day with the intention to quit smoking. They will be randomized to one of two conditions: Early Withdrawal Exposure + Withdrawal Regulation Training (E + WT) or Relaxation Training control (RT). The E + WT condition will consist of the development, application, modification, and repeated practice of individualized withdrawal regulation strategies (e.g., behavioral and cognitive strategies for allaying withdrawal symptoms) over three separate sessions that will each span the first four hours of abstinence. The RT condition will control for the therapeutic contact received by those in the E + WT condition. While the proposed investigation is expected to prove feasible, the proposed pilot study will provide an array of data critical to the advancement of the study design, recruitment and retention strategies, and treatment protocol, which includes the treatment manuals. Furthermore, outcome data will allow for the refinement of effect size estimates of the experimental intervention. Finally, candidate mediators (e.g., withdrawal symptoms) and moderators (e.g., tobacco dependence) will be investigated via established analyses. These data will advance the experimental intervention with a focus on targeting mechanisms of change as well as participant characteristics to which the intervention may be tailored. The experimental intervention described in the current application has the potential to ultimately enhance the efficacy of existing smoking cessation interventions and will therefore contribute uniquely to the field. PUBLIC HEALTH RELEVANCE: Smoking remains the single most preventable cause of morbidity and mortality in the United States, accounting for approximately half a million deaths every year. The current study will investigate the feasibility, potential efficacy, and mechanisms of change of a novel smoking cessation intervention. The current study will thus provide essential information regarding a treatment that has the potential to enhance the efficacy of existing smoking cessation interventions, thereby having a beneficial impact on the public health of the United States.

DESCRIPTION (provided by applicant): E-cigarettes are quickly becoming the most commonly used inhaled tobacco product in the U.S. after tobacco cigarettes. Although e-cigarettes may pose a threat to the public health, more research on these products is needed to inform and guide FDA regulation. Indeed, no data exist on the time course or clinical significance of e-cigarette withdrawal, and therefore a complete understanding of the addictive nature of these products is unknown. As the first of any empirical study to focus on e-cigarette withdrawal effects, the objectives of the proposed project are to: 1) characterize the early time course of e-cigarette withdrawal effects; 2) evaluate the clinical significance of early e-cigarett withdrawal effects; 3) compare the time course and clinical significance of early e-cigarette withdrawal effects to the time course and clinical significance of early tobacco withdrawal effects; and 4) examine moderators of the time course and clinical significance of early e-cigarette withdrawal effects. Participants will be 150 e-cigarette users and 150 tobacco cigarette users who will participate in two counterbalanced experimental sessions involving either 4 hours of abstinence or smoking as usual. Withdrawal measures will include negative affect (Wisconsin Smoking Withdrawal Scale), physical symptoms (Minnesota Nicotine Withdrawal Scale), multifaceted craving (Tobacco Craving Questionnaire), anhedonia (Tripartite Pleasure Inventory), perceived reinforcement value of smoking (Cigarette Choice Procedure), and open-ended report. After baseline assessment, withdrawal measures will be administered every 30 minutes. At the conclusion of the 4-hour period, participants will complete the Behavioral Smoking Lapse Analogue Task, a clinically relevant analogue task of smoking lapse that measures the ability to resist the temptation to smoke under conditions in which it is advantageous to remain abstinent. Candidate moderator variables assessed at intake will include demographic characteristics, e-cigarette history and use characteristics, smoking dependence, thoughts about abstinence, abstinence-related expectancies, and intolerance for smoking abstinence discomfort. Analyses will evaluate e-cigarette withdrawal effect differences between abstinent and non-abstinent experimental sessions, test the relationships between e-cigarette withdrawal effects and performance on the Behavioral Smoking Lapse Analogue Task, determine if withdrawal effects and their relationships to performance on the Behavioral Smoking Lapse Analogue Task differ between e-cigarette users and tobacco cigarette users, and evaluate whether e-cigarette withdrawal effects and their relationships to performance on the Behavioral Smoking Lapse Analogue Task differ across levels of the candidate moderator variables. In conclusion, the proposed study will facilitate FDA regulation of e-cigarettes by informing the addictive nature of these products and determining those populations that may be especially vulnerable to e- cigarette addiction.

Cigarette smoking remains the single most preventable cause of mortality and morbidity in the United States. Long-term abstinence rates for even the most rigorous of smoking cessation treatments range between 20% and 35%. It is therefore essential that research continue to investigate novel smoking cessation interventions. Leading contemporary theories of addiction motivation posit that the escape or avoidance of negative affect withdrawal (NAW) symptoms (e.g., anger, anxiety, and depression/sadness) constitutes a strong motivational basis for cigarette smoking and plays a critical role in relapse to cigarette use. However, whereas NAW symptoms appear to exert a powerful influence on smoking cessation treatment outcome, smoking cessation interventions may exert only modest effects on NAW symptoms. Accordingly, it has been proposed that smoking cessation interventions may be augmented by aiding smokers in the practice of NAW regulation strategies. The primary goal of this investigation is to evaluate an early withdrawal exposure plus NAW regulation training intervention for smoking cessation. Specific aims include evaluating the efficacy of the treatment components and investigating potential mediators and moderators of the treatment components. Participants will be adult smokers (N = 400) of at least 5 cigarettes per day with the intention to quit smoking. Using a factorial design, participants will be randomized to early withdrawal exposure (yes vs. no) and behavioral intervention (NAW regulation training vs. relaxation control training), resulting in four distinct conditions. Our primary hypothesis is that early withdrawal exposure plus NAW regulation training will produce higher rates of seven-day point-prevalence abstinence at 1, 3, and 6 months after end-of-treatment, suggesting a synergistic (i.e., non-additive) effect of the two intervention components. Mediators (e.g., in-session withdrawal symptoms) and moderators (e.g., demographic characteristics, tobacco dependence) will be investigated via established analyses. These data will advance the experimental intervention with a focus on targeting mechanisms of change as well as participant characteristics to which the intervention may be tailored. The experimental intervention described in the current proposal has the potential to ultimately enhance the efficacy of existing smoking cessation interventions and will therefore contribute uniquely to the field.