NCT05772845 · State University of New York at Buffalo
Vaping and Smoking Withdrawal Project
(VASP)
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Acute (24-hour) abstinence
Participants will be asked to abstain from all tobacco/nicotine for 24 hours prior to the visit
BEHAVIORAL
Ad libitum smoking/vaping
Participants will be asked to smoke/vape as usual during the 24 hours prior to the visit
Primary outcome measures
Wisconsin Smoking Withdrawal Scale - anger 0.5
Time frame: 0.5 hours
anger subscale score
Wisconsin Smoking Withdrawal Scale - anger 2.5
Time frame: 2.5 hours
anger subscale score
Wisconsin Smoking Withdrawal Scale - anx 0.5
Time frame: 0.5 hours
anxiety subscale score
Wisconsin Smoking Withdrawal Scale - anx 2.5
Time frame: 2.5 hours
anxiety subscale score
Wisconsin Smoking Withdrawal Scale - sad 0.5
Time frame: 0.5 hours
sadness subscale score
Wisconsin Smoking Withdrawal Scale - sad 2.5
Time frame: 2.5 hours
sadness subscale score
Wisconsin Smoking Withdrawal Scale - conc 0.5
Time frame: 0.5 hours
difficulty concentrating subscale score
Wisconsin Smoking Withdrawal Scale - conc 2.5
Time frame: 2.5 hours
difficulty concentrating subscale score
Wisconsin Smoking Withdrawal Scale - sleep 0.5
Time frame: 0.5 hours
sleep subscale score
Wisconsin Smoking Withdrawal Scale - sleep 2.5
Time frame: 2.5 hours
sleep subscale score
Wisconsin Smoking Withdrawal Scale - appetite 0.5
Time frame: 0.5 hours
appetite subscale score
Wisconsin Smoking Withdrawal Scale - appetite 2.5
Time frame: 2.5 hours
appetite subscale score
Mood and Physical Symptoms Scale - 0.5
Time frame: 0.5 hours
single-item indicators of withdrawal facets
Mood and Physical Symptoms Scale - 2.5
Time frame: 2.5 hours
single-item indicators of withdrawal facets
Minnesota Nicotine Withdrawal Scale - 0.5
Time frame: 0.5 hours
17-item version with indicators of various withdrawal facets
Minnesota Nicotine Withdrawal Scale - 2.5
Time frame: 2.5 hours
17-item version with indicators of various withdrawal facets
Positive and Negative Affect Scale - PA 0.5
Time frame: 0.5 hours
positive affect subscale score
Positive and Negative Affect Scale - PA 2.5
Time frame: 2.5 hours
positive affect subscale score
Positive and Negative Affect Scale - NA 0.5
Time frame: 0.5 hours
negative affect subscale score
Positive and Negative Affect Scale - NA 2.5
Time frame: 2.5 hours
negative affect subscale score
Snaith-Hamilton Pleasure Scale 0.5
Time frame: 0.5 hours
total score
Snaith-Hamilton Pleasure Scale 2.5
Time frame: 2.5 hours
total score
Questionnaire on Vaping Craving 0.5
Time frame: 0.5 hours
total craving score
Questionnaire on Vaping Craving 2.5
Time frame: 2.5 hours
total craving score
Questionnaire on Smoking Urges - Brief 0.5
Time frame: 0.5 hours
total craving score
Questionnaire on Smoking Urges - Brief 2.5
Time frame: 2.5 hours
total craving score
PhenX Toolkit Insomnia Severity Index 0.5
Time frame: 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
PhenX Toolkit Insomnia Severity Index 2.5
Time frame: 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
Time frame: 0.5 hours
3-item scale
Restlessness ratings 2.5
Time frame: 2.5 hours
3-item scale
Restlessness and Agitation Questionnaire - Modified 0.5
Time frame: 0.5 hours
total score on subset of behavioral indicators
Restlessness and Agitation Questionnaire - Modified 2.5
Time frame: 2.5 hours
total score on subset of behavioral indicators
Identical Pair Continuous Performance Task
Time frame: ~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.
n-back working memory task
Time frame: ~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.
Stop signal reaction time task
Time frame: ~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.
kcal consumed
Time frame: 3 hours
Fat, protein, and carbohydrate calories, and total calories, consumed during the visit.
Hypothetical commodity purchase task - vaping intensity 0.5
Time frame: 0.5 hours
Intensity of demand
Hypothetical commodity purchase task - vaping intensity 2.5
Time frame: 2.5 hours
intensity of demand
Hypothetical commodity purchase task - vaping persistence 0.5
Time frame: 0.5 hours
persistence of demand
Hypothetical commodity purchase task - vaping persistence 2.5
Time frame: 2.5 hours
persistence of demand
Hypothetical commodity purchase task - smoking intensity 0.5
Time frame: 0.5 hours
intensity of demand
Hypothetical commodity purchase task - smoking intensity 0.5
Time frame: 2.5 hours
intensity of demand
Hypothetical commodity purchase task - smoking persistence 0.5
Time frame: 0.5 hours
persistence of demand
Hypothetical commodity purchase task - smoking persistence 2.5
Time frame: 2.5 hours
persistence of demand
Choice Behavior Under Cued Conditions (CBUCC) Task - spend vape
Time frame: 3 hours
Spending for vape puffs
Choice Behavior Under Cued Conditions (CBUCC) Task - spend cig
Time frame: 3 hours
Spending for cigarette puffs
Choice Behavior Under Cued Conditions (CBUCC) Task - spend water
Time frame: 3 hours
Spending for water control
Choice Behavior Under Cued Conditions (CBUCC) Task - crave vape
Time frame: 3 hours
Craving for vape puffs
Choice Behavior Under Cued Conditions (CBUCC) Task - crave cig
Time frame: 3 hours
Craving for cigarette puffs
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 Current
Exclusion criteria
- 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)
Where
- Buffalo, New York
Collaborators
Roswell Park Cancer Institute, National Institute on Drug Abuse (NIDA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 9, 2026 · Source of record for eligibility and locations