Acute Abstinence From Cigarettes vs E-cigarettes (ENDS)VASPNCT05772845
Vaping and Smoking Withdrawal Project
A study testing Acute (24-hour) abstinence and Ad libitum smoking/vaping in people with Acute Abstinence From Cigarettes vs E-cigarettes (ENDS), run by State University of New York at Buffalo at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Abstinence From Cigarettes vs E-cigarettes (ENDS)
- What is being tested?
- Acute (24-hour) abstinence and Ad libitum smoking/vaping
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Feb 2023to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 15Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University at Buffalo
Buffalo, New York, 14260
Larry Hawk, PhD, 7166450192, lhawk@buffalo.edu
About this study
Official title: A Controlled Evaluation of Abstinence-Induced Withdrawal and Motivation to Vape/Smoke Among Daily ENDS Users vs. Cigarette Smokers
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.
Read the detailed description
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.
- Being tested
- Acute (24-hour) abstinence, Ad libitum smoking/vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acute (24-hour) abstinenceBehavioural
Participants will be asked to abstain from all tobacco/nicotine for 24 hours prior to the visit
Ad libitum smoking/vapingBehavioural
Participants will be asked to smoke/vape as usual during the 24 hours prior to the visit
| Study group | Role | What they receive |
|---|---|---|
| Daily Users of ENDS | Other | Participants who use nicotine-containing ENDS daily or near-daily but who do NOT smoke combustible cigarettes daily or near-daily. Receives: Behavioral: Acute (24-hour) abstinence; Behavioral: Ad libitum smoking/vaping |
| Daily Users of Combustible Cigarettes | Other | Participants who smoke combustible cigarettes daily or near-daily but do NOT use nicotine-containing ENDS daily or near-daily. Receives: Behavioral: Acute (24-hour) abstinence; Behavioral: Ad libitum smoking/vaping |
| Daily Dual Users of ENDS and Combustible Cigarettes | Other | Participants who both use nicotine-containing ENDS and combustible cigarettes daily or near-daily Receives: Behavioral: Acute (24-hour) abstinence; Behavioral: Ad libitum smoking/vaping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wisconsin Smoking Withdrawal Scale - anger 0.5
anger subscale score
Measured: 0.5 hours
Wisconsin Smoking Withdrawal Scale - anger 2.5
anger subscale score
Measured: 2.5 hours
Wisconsin Smoking Withdrawal Scale - anx 0.5
anxiety subscale score
Measured: 0.5 hours
Wisconsin Smoking Withdrawal Scale - anx 2.5
anxiety subscale score
Measured: 2.5 hours
Wisconsin Smoking Withdrawal Scale - sad 0.5
sadness subscale score
Measured: 0.5 hours
Wisconsin Smoking Withdrawal Scale - sad 2.5
sadness subscale score
Measured: 2.5 hours
Wisconsin Smoking Withdrawal Scale - conc 0.5
difficulty concentrating subscale score
Measured: 0.5 hours
Wisconsin Smoking Withdrawal Scale - conc 2.5
difficulty concentrating subscale score
Measured: 2.5 hours
Wisconsin Smoking Withdrawal Scale - sleep 0.5
sleep subscale score
Measured: 0.5 hours
Wisconsin Smoking Withdrawal Scale - sleep 2.5
sleep subscale score
Measured: 2.5 hours
Wisconsin Smoking Withdrawal Scale - appetite 0.5
appetite subscale score
Measured: 0.5 hours
Wisconsin Smoking Withdrawal Scale - appetite 2.5
appetite subscale score
Measured: 2.5 hours
Mood and Physical Symptoms Scale - 0.5
single-item indicators of withdrawal facets
Measured: 0.5 hours
Mood and Physical Symptoms Scale - 2.5
single-item indicators of withdrawal facets
Measured: 2.5 hours
Minnesota Nicotine Withdrawal Scale - 0.5
17-item version with indicators of various withdrawal facets
Measured: 0.5 hours
Minnesota Nicotine Withdrawal Scale - 2.5
17-item version with indicators of various withdrawal facets
Measured: 2.5 hours
Positive and Negative Affect Scale - PA 0.5
positive affect subscale score
Measured: 0.5 hours
Positive and Negative Affect Scale - PA 2.5
positive affect subscale score
Measured: 2.5 hours
Positive and Negative Affect Scale - NA 0.5
negative affect subscale score
Measured: 0.5 hours
Positive and Negative Affect Scale - NA 2.5
negative affect subscale score
Measured: 2.5 hours
Snaith-Hamilton Pleasure Scale 0.5
total score
Measured: 0.5 hours
Snaith-Hamilton Pleasure Scale 2.5
total score
Measured: 2.5 hours
Questionnaire on Vaping Craving 0.5
total craving score
Measured: 0.5 hours
Questionnaire on Vaping Craving 2.5
total craving score
Measured: 2.5 hours
Questionnaire on Smoking Urges - Brief 0.5
total craving score
Measured: 0.5 hours
Questionnaire on Smoking Urges - Brief 2.5
total craving score
Measured: 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
Measured: 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
Measured: 2.5 hours
Restlessness ratings 0.5
3-item scale
Measured: 0.5 hours
Restlessness ratings 2.5
3-item scale
Measured: 2.5 hours
Restlessness and Agitation Questionnaire - Modified 0.5
total score on subset of behavioral indicators
Measured: 0.5 hours
Restlessness and Agitation Questionnaire - Modified 2.5
total score on subset of behavioral indicators
Measured: 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.
Measured: ~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.
Measured: ~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.
Measured: ~2 hours
kcal consumed
Fat, protein, and carbohydrate calories, and total calories, consumed during the visit.
Measured: 3 hours
Hypothetical commodity purchase task - vaping intensity 0.5
Intensity of demand
Measured: 0.5 hours
Hypothetical commodity purchase task - vaping intensity 2.5
intensity of demand
Measured: 2.5 hours
Hypothetical commodity purchase task - vaping persistence 0.5
persistence of demand
Measured: 0.5 hours
Hypothetical commodity purchase task - vaping persistence 2.5
persistence of demand
Measured: 2.5 hours
Hypothetical commodity purchase task - smoking intensity 0.5
intensity of demand
Measured: 0.5 hours
Hypothetical commodity purchase task - smoking intensity 0.5
intensity of demand
Measured: 2.5 hours
Hypothetical commodity purchase task - smoking persistence 0.5
persistence of demand
Measured: 0.5 hours
Hypothetical commodity purchase task - smoking persistence 2.5
persistence of demand
Measured: 2.5 hours
Choice Behavior Under Cued Conditions (CBUCC) Task - spend vape
Spending for vape puffs
Measured: 3 hours
Choice Behavior Under Cued Conditions (CBUCC) Task - spend cig
Spending for cigarette puffs
Measured: 3 hours
Choice Behavior Under Cued Conditions (CBUCC) Task - spend water
Spending for water control
Measured: 3 hours
Choice Behavior Under Cued Conditions (CBUCC) Task - crave vape
Craving for vape puffs
Measured: 3 hours
Choice Behavior Under Cued Conditions (CBUCC) Task - crave cig
Craving for cigarette puffs
Measured: 3 hours
Secondary outcomes (5)
modified Cigarette evaluation questionnaire
subjective/sensory aspects of smoking
Measured: 3.5 hours
modified e-Cigarette evaluation questionnaire
subjective/sensory aspects of vaping
Measured: 3.5 hours
Heart rate
Heart rate, in beats per minute
Measured: assessed at ~30-minute intervals
Somatic/side effect checklist
Assesses a range of somatic and psychological symptoms (e.g., headache, fatigue, anxiety)
Measured: 0.5 hours
Somatic/side effect checklist
Assesses a range of somatic and psychological symptoms (e.g., headache, fatigue, anxiety)
Measured: 2.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2023
- Study start14 Feb 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Abstinence From Cigarettes vs E-cigarettes (ENDS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All participants will complete two visits, one following 24-hour abstinence, the other while smoking/vaping as usual.
- Masking
- None (open label)
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- State University of New York at Buffalo
- Sponsor type
- University, hospital or other
- Collaborators
- Roswell Park Cancer Institute, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Larry Hawk, Ph.D., State University of New York at Buffalo
- Investigators
- Larry Hawk, PhD, Principal investigator, University at Buffalo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05772845
- Sponsor's protocol ID
- STUDY00006122
- Other IDs
- R01DA054276
- Acronym
- VASP
- Status last verified
- Mar 2026
- First submitted
- 16 Feb 2023
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We plan to make the full de-identified data set with metadata available through the National Addiction and HIV Data Archive Program (NAHDAP).
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Evaluation of Abstinence-Induced Withdrawal and Motivation to Vape/Smoke Among Daily ENDS Users vs. Cigarette Smokers
- ClinicalTrials.gov ID
- NCT05772845
- Acronym / sponsor ID
- VASP / STUDY00006122
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- State University of New York at BuffaloUniversity, hospital or other
- Collaborators
- Roswell Park Cancer Institute, National Institute on Drug Abuse (NIDA)
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 16 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All participants will complete two visits, one following 24-hour abstinence, the other while smoking/vaping as usual.
| Arm | Type | Receives |
|---|---|---|
| Daily Users of ENDS | Other | Behavioral: Acute (24-hour) abstinence, Behavioral: Ad libitum smoking/vapingParticipants who use nicotine-containing ENDS daily or near-daily but who do NOT smoke combustible cigarettes daily or near-daily. |
| Daily Users of Combustible Cigarettes | Other | Behavioral: Acute (24-hour) abstinence, Behavioral: Ad libitum smoking/vapingParticipants who smoke combustible cigarettes daily or near-daily but do NOT use nicotine-containing ENDS daily or near-daily. |
| Daily Dual Users of ENDS and Combustible Cigarettes | Other | Behavioral: Acute (24-hour) abstinence, Behavioral: Ad libitum smoking/vapingParticipants who both use nicotine-containing ENDS and combustible cigarettes daily or near-daily |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acute (24-hour) abstinenceParticipants will be asked to abstain from all tobacco/nicotine for 24 hours prior to the visit | Behavioural | Daily Dual Users of ENDS and Combustible Cigarettes, Daily Users of Combustible Cigarettes, Daily Users of ENDS |
| Ad libitum smoking/vapingParticipants will be asked to smoke/vape as usual during the 24 hours prior to the visit | Behavioural | Daily Dual Users of ENDS and Combustible Cigarettes, Daily Users of Combustible Cigarettes, Daily Users of ENDS |
Primary outcome
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
5 secondary outcomes
modified Cigarette evaluation questionnaire
Time frame: 3.5 hours
modified e-Cigarette evaluation questionnaire
Time frame: 3.5 hours
Heart rate
Time frame: assessed at ~30-minute intervals
Somatic/side effect checklist
Time frame: 0.5 hours
Somatic/side effect checklist
Time frame: 2.5 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2026.
- Individual participant dataSharing planned: Yes. We plan to make the full de-identified data set with metadata available through the National Addiction and HIV Data Archive Program (NAHDAP).
Related trials for Acute Abstinence From Cigarettes vs E-cigarettes (ENDS)
Recruiting
Vaping and Smoking Project in People With Schizophrenia
Acute Abstinence From Cigarettes vs E-cigarettes (ENDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Larry Hawk, PhD principal investigator
University at Buffalo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute (24-hour) abstinence and Ad libitum smoking/vaping in people with Acute Abstinence From Cigarettes vs E-cigarettes (ENDS), run by State University of New York at Buffalo at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Larry Hawk, PhD (716-645-0192, lhawk@buffalo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wisconsin Smoking Withdrawal Scale - anger 0.5 (time frame: 0.5 hours). The study lists 49 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.