A Controlled Evaluation of Abstinence-Induced Withdrawal and Motivation to Vape/Smoke Among Daily ENDS Users vs. Cigarette Smokers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 370
- 试验地点
- 1
- 主要终点
- Positive and Negative Affect Scale - NA 0.5
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6+ months of daily/near-daily nicotine vaping and/or cigarette smoking (to yield 160 vapers, 160 smokers, 50 dual users)
- •200+ ng/mL cotinine on a commercially-available quick screen
排除标准
- •intention to quit daily/near-daily vaping/smoking in the next month
- •current (2+ days out of the past 7) use of pipe tobacco, hookah/shisha, smokeless tobacco, dissolvable tobacco, nicotine pouches. For vaping group only, current (2+ days out of past 7) use of cigars, cigarillos, or filtered cigars that are filled with tobacco or a mix of tobacco and marijuana
- •current use of any smoking cessation medication
- •current severe substance dependence other than tobacco/nicotine (including cannabis; NIDA Modified ASSIST of 27+)
- •current (past 2 weeks) suicidal ideation with intent and/or plan
- •current antipsychotic medications or lifetime history of schizophrenia or bipolar disorder
- •pregnancy (intake urine screen)
- •Original Exclusion Criteria that have been modified or eliminated:
- •>1 use in past month of tobacco/nicotine products other than ENDS and combustible cigarettes (modified 5/19/25 - see current exclusion criteria)
- •alcohol: AUDIT > 15 for males and >13 for females (eliminated 7/25/23)
- •current major depression (PHQ-9>11) (eliminated 7/25/23)
- •suicide risk (answer to question #9 on PHQ-9 is anything other than "Not at all") (modified 11/17/23 - see current exclusion criteria)
研究组 & 干预措施
Daily Users of ENDS
Participants who use nicotine-containing ENDS daily or near-daily but who do NOT smoke combustible cigarettes daily or near-daily.
干预措施: Acute (24-hour) abstinence (Behavioral)
Daily Users of ENDS
Participants who use nicotine-containing ENDS daily or near-daily but who do NOT smoke combustible cigarettes daily or near-daily.
干预措施: Ad libitum smoking/vaping (Behavioral)
Daily Users of Combustible Cigarettes
Participants who smoke combustible cigarettes daily or near-daily but do NOT use nicotine-containing ENDS daily or near-daily.
干预措施: Acute (24-hour) abstinence (Behavioral)
Daily Users of Combustible Cigarettes
Participants who smoke combustible cigarettes daily or near-daily but do NOT use nicotine-containing ENDS daily or near-daily.
干预措施: Ad libitum smoking/vaping (Behavioral)
Daily Dual Users of ENDS and Combustible Cigarettes
Participants who both use nicotine-containing ENDS and combustible cigarettes daily or near-daily
干预措施: Acute (24-hour) abstinence (Behavioral)
Daily Dual Users of ENDS and Combustible Cigarettes
Participants who both use nicotine-containing ENDS and combustible cigarettes daily or near-daily
干预措施: Ad libitum smoking/vaping (Behavioral)
结局指标
主要结局
Positive and Negative Affect Scale - NA 0.5
时间窗: 0.5 hours
negative affect subscale score
Restlessness ratings 2.5
时间窗: 2.5 hours
3-item scale
Wisconsin Smoking Withdrawal Scale - appetite 0.5
时间窗: 0.5 hours
appetite subscale score
Positive and Negative Affect Scale - PA 0.5
时间窗: 0.5 hours
positive affect subscale score
Snaith-Hamilton Pleasure Scale 2.5
时间窗: 2.5 hours
total score
Questionnaire on Smoking Urges - Brief 2.5
时间窗: 2.5 hours
total craving score
PhenX Toolkit Insomnia Severity Index 0.5
时间窗: 0.5 hours
7-item scale (but item #5 is omitted because of the short time-frame), total score impairment and interference with daily functioning
Restlessness and Agitation Questionnaire - Modified 2.5
时间窗: 2.5 hours
total score on subset of behavioral indicators
kcal consumed
时间窗: 3 hours
Fat, protein, and carbohydrate calories, and total calories, consumed during the visit.
Hypothetical commodity purchase task - vaping intensity 0.5
时间窗: 0.5 hours
Intensity of demand
Choice Behavior Under Cued Conditions (CBUCC) Task - crave vape
时间窗: 3 hours
Craving for vape puffs
Minnesota Nicotine Withdrawal Scale - 2.5
时间窗: 2.5 hours
17-item version with indicators of various withdrawal facets
Wisconsin Smoking Withdrawal Scale - anger 0.5
时间窗: 0.5 hours
anger subscale score
Mood and Physical Symptoms Scale - 2.5
时间窗: 2.5 hours
single-item indicators of withdrawal facets
Wisconsin Smoking Withdrawal Scale - sleep 0.5
时间窗: 0.5 hours
sleep subscale score
Mood and Physical Symptoms Scale - 0.5
时间窗: 0.5 hours
single-item indicators of withdrawal facets
Minnesota Nicotine Withdrawal Scale - 0.5
时间窗: 0.5 hours
17-item version with indicators of various withdrawal facets
Positive and Negative Affect Scale - PA 2.5
时间窗: 2.5 hours
positive affect subscale score
Positive and Negative Affect Scale - NA 2.5
时间窗: 2.5 hours
negative affect subscale score
Questionnaire on Vaping Craving 0.5
时间窗: 0.5 hours
total craving score
Hypothetical commodity purchase task - smoking persistence 2.5
时间窗: 2.5 hours
persistence of demand
Wisconsin Smoking Withdrawal Scale - anger 2.5
时间窗: 2.5 hours
anger subscale score
Wisconsin Smoking Withdrawal Scale - sleep 2.5
时间窗: 2.5 hours
sleep subscale score
Wisconsin Smoking Withdrawal Scale - appetite 2.5
时间窗: 2.5 hours
appetite subscale score
Snaith-Hamilton Pleasure Scale 0.5
时间窗: 0.5 hours
total score
PhenX Toolkit Insomnia Severity Index 2.5
时间窗: 2.5 hours
7-item scale (but item #5 is omitted because of the short time-frame), total score impairment and interference with daily functioning
Restlessness ratings 0.5
时间窗: 0.5 hours
3-item scale
Identical Pair Continuous Performance Task
时间窗: ~2 hours
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.
Choice Behavior Under Cued Conditions (CBUCC) Task - spend cig
时间窗: 3 hours
Spending for cigarette puffs
Wisconsin Smoking Withdrawal Scale - anx 0.5
时间窗: 0.5 hours
anxiety subscale score
Wisconsin Smoking Withdrawal Scale - anx 2.5
时间窗: 2.5 hours
anxiety subscale score
Wisconsin Smoking Withdrawal Scale - sad 0.5
时间窗: 0.5 hours
sadness subscale score
Wisconsin Smoking Withdrawal Scale - sad 2.5
时间窗: 2.5 hours
sadness subscale score
Wisconsin Smoking Withdrawal Scale - conc 0.5
时间窗: 0.5 hours
difficulty concentrating subscale score
Wisconsin Smoking Withdrawal Scale - conc 2.5
时间窗: 2.5 hours
difficulty concentrating subscale score
Stop signal reaction time task
时间窗: ~2 hours
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.
Hypothetical commodity purchase task - vaping persistence 2.5
时间窗: 2.5 hours
persistence of demand
Choice Behavior Under Cued Conditions (CBUCC) Task - spend vape
时间窗: 3 hours
Spending for vape puffs
Hypothetical commodity purchase task - vaping intensity 2.5
时间窗: 2.5 hours
intensity of demand
Hypothetical commodity purchase task - vaping persistence 0.5
时间窗: 0.5 hours
persistence of demand
Questionnaire on Vaping Craving 2.5
时间窗: 2.5 hours
total craving score
Questionnaire on Smoking Urges - Brief 0.5
时间窗: 0.5 hours
total craving score
Restlessness and Agitation Questionnaire - Modified 0.5
时间窗: 0.5 hours
total score on subset of behavioral indicators
n-back working memory task
时间窗: ~2 hours
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.
Hypothetical commodity purchase task - smoking intensity 0.5
时间窗: 2.5 hours
intensity of demand
Choice Behavior Under Cued Conditions (CBUCC) Task - spend water
时间窗: 3 hours
Spending for water control
Hypothetical commodity purchase task - smoking persistence 0.5
时间窗: 0.5 hours
persistence of demand
Choice Behavior Under Cued Conditions (CBUCC) Task - crave cig
时间窗: 3 hours
Craving for cigarette puffs
Hypothetical commodity purchase task - smoking intensity 0.5
时间窗: 0.5 hours
intensity of demand
次要结局
- modified Cigarette evaluation questionnaire(3.5 hours)
- modified e-Cigarette evaluation questionnaire(3.5 hours)
- Heart rate(assessed at ~30-minute intervals)
- Somatic/side effect checklist(2.5 hours)
- Somatic/side effect checklist(0.5 hours)
研究者
Larry Hawk, Ph.D.
Principal Investigator
State University of New York at Buffalo