The proposed research, which will systematically and comprehensively characterize the withdrawal among daily vapers compared to daily smokers of combustible cigarettes, filling critical gaps in the understanding of electronic nicotine delivery systems (ENDS) dependence/abuse liability and contributing to the development of therapies for tobacco/nicotine use, the leading preventable cause of death in the US.
Withdrawal is a key, multi-faceted component of tobacco/nicotine dependence. Because withdrawal symptoms are theorized to drive relapse, facets of withdrawal (e.g., craving, negative affect) are the targets of most current and emerging treatments. Despite the central importance of withdrawal, and a voluminous literature on withdrawal from combustible cigarette smoking, little is known about withdrawal from electronic nicotine delivery systems (ENDS). To overcome critical barriers to progress in the field, the first-ever prospective, controlled comparison of abstinence-induced withdrawal between ENDS vapers and cigarette smokers is proposed. Participants will be 160 established daily vapers (including former smokers and dual users who smoke occasionally), 160 established daily smokers (including former vapers and dual users who vape occasionally), and (for exploratory comparisons) 50 established daily dual users, who smoke and vape daily. Participants will complete two 4-hour lab visits; the order of the ad lib use visit and the abstinent visit (which follows 24 hours of abstinence) will be randomized across participants. To advance knowledge of ENDS withdrawal, state-of-the-science, multi-measure, multi-method assessments of key withdrawal facets (negative affect, craving, difficulty concentrating, restlessness, sleep, and appetite, as well as anhedonia/positive affect and somatic effects) will be employed. For each facet, the hypothesis that withdrawal magnitude is lower among vapers compared to smokers will be tested. To inform theory and intervention development, the behavioral significance of ENDS withdrawal will also be evaluated, testing the hypotheses that abstinence will increase the motivation to vape/smoke and this group difference will be accounted for (mediated) by vaper/smoker differences in one or more withdrawal facets. Exploratory analyses will examine whether group differences in withdrawal are accounted for (mediate) by differential nicotine exposure, explore the role of individual differences (e.g., sex, rate of nicotine metabolism, expectancies), and examine differences among sub-groups of vapers. The impact of this much-needed, detailed characterization of withdrawal from ENDS is enhanced by the inclusion of a comparator of great public health significance, cigarette smoking. In addition, by characterizing the specific withdrawal facets that drive motivation to vape/smoke, the proposed work will identify promising intervention targets for subsequent treatment development efforts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
370
Participants will be asked to abstain from all tobacco/nicotine for 24 hours prior to the visit
Participants will be asked to smoke/vape as usual during the 24 hours prior to the visit
University at Buffalo
Buffalo, New York, United States
RECRUITINGWisconsin Smoking Withdrawal Scale - anger 0.5
anger subscale score
Time frame: 0.5 hours
Wisconsin Smoking Withdrawal Scale - anger 2.5
anger subscale score
Time frame: 2.5 hours
Wisconsin Smoking Withdrawal Scale - anx 0.5
anxiety subscale score
Time frame: 0.5 hours
Wisconsin Smoking Withdrawal Scale - anx 2.5
anxiety subscale score
Time frame: 2.5 hours
Wisconsin Smoking Withdrawal Scale - sad 0.5
sadness subscale score
Time frame: 0.5 hours
Wisconsin Smoking Withdrawal Scale - sad 2.5
sadness subscale score
Time frame: 2.5 hours
Wisconsin Smoking Withdrawal Scale - conc 0.5
difficulty concentrating subscale score
Time frame: 0.5 hours
Wisconsin Smoking Withdrawal Scale - conc 2.5
difficulty concentrating subscale score
Time frame: 2.5 hours
Wisconsin Smoking Withdrawal Scale - sleep 0.5
sleep subscale score
Time frame: 0.5 hours
Wisconsin Smoking Withdrawal Scale - sleep 2.5
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sleep subscale score
Time frame: 2.5 hours
Wisconsin Smoking Withdrawal Scale - appetite 0.5
appetite subscale score
Time frame: 0.5 hours
Wisconsin Smoking Withdrawal Scale - appetite 2.5
appetite subscale score
Time frame: 2.5 hours
Mood and Physical Symptoms Scale - 0.5
single-item indicators of withdrawal facets
Time frame: 0.5 hours
Mood and Physical Symptoms Scale - 2.5
single-item indicators of withdrawal facets
Time frame: 2.5 hours
Minnesota Nicotine Withdrawal Scale - 0.5
17-item version with indicators of various withdrawal facets
Time frame: 0.5 hours
Minnesota Nicotine Withdrawal Scale - 2.5
17-item version with indicators of various withdrawal facets
Time frame: 2.5 hours
Positive and Negative Affect Scale - PA 0.5
positive affect subscale score
Time frame: 0.5 hours
Positive and Negative Affect Scale - PA 2.5
positive affect subscale score
Time frame: 2.5 hours
Positive and Negative Affect Scale - NA 0.5
negative affect subscale score
Time frame: 0.5 hours
Positive and Negative Affect Scale - NA 2.5
negative affect subscale score
Time frame: 2.5 hours
Snaith-Hamilton Pleasure Scale 0.5
total score
Time frame: 0.5 hours
Snaith-Hamilton Pleasure Scale 2.5
total score
Time frame: 2.5 hours
Questionnaire on Vaping Craving 0.5
total craving score
Time frame: 0.5 hours
Questionnaire on Vaping Craving 2.5
total craving score
Time frame: 2.5 hours
Questionnaire on Smoking Urges - Brief 0.5
total craving score
Time frame: 0.5 hours
Questionnaire on Smoking Urges - Brief 2.5
total craving score
Time frame: 2.5 hours
PhenX Toolkit Insomnia Severity Index 0.5
7-item scale (but item #5 is omitted because of the short time-frame), total score impairment and interference with daily functioning
Time frame: 0.5 hours
PhenX Toolkit Insomnia Severity Index 2.5
7-item scale (but item #5 is omitted because of the short time-frame), total score impairment and interference with daily functioning
Time frame: 2.5 hours
Restlessness ratings 0.5
3-item scale
Time frame: 0.5 hours
Restlessness ratings 2.5
3-item scale
Time frame: 2.5 hours
Restlessness and Agitation Questionnaire - Modified 0.5
total score on subset of behavioral indicators
Time frame: 0.5 hours
Restlessness and Agitation Questionnaire - Modified 2.5
total score on subset of behavioral indicators
Time frame: 2.5 hours
Identical Pair Continuous Performance Task
Sustained attention, or vigilance, is the ability to maintain alertness to detect infrequent target stimuli during a long, monotonous task (e.g., Mackworth, 1948). We will use a version of the identical-pairs continuous performance task (Cornblatt et al., 1988) in which participants attend to a series of 800 4-digit numbers on a computer monitor (100-ms stimulus duration; 1500-ms ISI). Participants are asked to press the keyboard space bar only when the stimulus is identical to the immediately preceding stimulus (10% targets; Cooper et al., 2020; Rhodes \& Hawk, 2016). Percent correct hits (target detections) is the primary outcome.
Time frame: ~2 hours
n-back working memory task
The n-back task (e.g., Strand et al., 2012; Rhodes \& Hawk, 2016) requires indicating whether each stimulus in a rapidly presented series matches the location of the stimulus presented n stimuli before (e.g., n=0,1,2). Stimuli are small grey circles (100 ms; 30% targets). The focus here is on conditions that place marked demands on the "central executive" by requiring ongoing mental manipulation (i.e., n=2; see Baddeley, 2003). Brief practice with a 1-back and 2-back will be followed by 2 100-trial blocks of the 2-back. Accuracy is the primary outcome.
Time frame: ~2 hours
Stop signal reaction time task
We will employ the stop-signal paradigm (Logan et al., 1984), which provides a relatively pure index response inhibition (e.g., Nigg, 2001). In our typical task (e.g., Hawk et al., 2018; Rhodes \& Hawk, 2016), participants button press to indicate whether the "go" signal (\<-- or --\>) is pointing left or right. After a brief "go" practice, the stop signal (100-ms tone) is introduced, and participants complete 3 64-trail bocks during with they are asked to respond as quickly as possible but to not respond on stop signal trials (25% of trials). The stop signal occurs after go signal onset and adjusts dynamically across trials to yield \~50% inhibition (Logan et al., 1997). The primary outcome is stop signal reaction time (SSRT), an estimate of the speed of inhibition.
Time frame: ~2 hours
kcal consumed
Fat, protein, and carbohydrate calories, and total calories, consumed during the visit.
Time frame: 3 hours
Hypothetical commodity purchase task - vaping intensity 0.5
Intensity of demand
Time frame: 0.5 hours
Hypothetical commodity purchase task - vaping intensity 2.5
intensity of demand
Time frame: 2.5 hours
Hypothetical commodity purchase task - vaping persistence 0.5
persistence of demand
Time frame: 0.5 hours
Hypothetical commodity purchase task - vaping persistence 2.5
persistence of demand
Time frame: 2.5 hours
Hypothetical commodity purchase task - smoking intensity 0.5
intensity of demand
Time frame: 0.5 hours
Hypothetical commodity purchase task - smoking intensity 0.5
intensity of demand
Time frame: 2.5 hours
Hypothetical commodity purchase task - smoking persistence 0.5
persistence of demand
Time frame: 0.5 hours
Hypothetical commodity purchase task - smoking persistence 2.5
persistence of demand
Time frame: 2.5 hours
Choice Behavior Under Cued Conditions (CBUCC) Task - spend vape
Spending for vape puffs
Time frame: 3 hours
Choice Behavior Under Cued Conditions (CBUCC) Task - spend cig
Spending for cigarette puffs
Time frame: 3 hours
Choice Behavior Under Cued Conditions (CBUCC) Task - spend water
Spending for water control
Time frame: 3 hours
Choice Behavior Under Cued Conditions (CBUCC) Task - crave vape
Craving for vape puffs
Time frame: 3 hours
Choice Behavior Under Cued Conditions (CBUCC) Task - crave cig
Craving for cigarette puffs
Time frame: 3 hours
modified Cigarette evaluation questionnaire
subjective/sensory aspects of smoking
Time frame: 3.5 hours
modified e-Cigarette evaluation questionnaire
subjective/sensory aspects of vaping
Time frame: 3.5 hours
Heart rate
Heart rate, in beats per minute
Time frame: assessed at ~30-minute intervals
Somatic/side effect checklist
Assesses a range of somatic and psychological symptoms (e.g., headache, fatigue, anxiety)
Time frame: 0.5 hours
Somatic/side effect checklist
Assesses a range of somatic and psychological symptoms (e.g., headache, fatigue, anxiety)
Time frame: 2.5 hours