Acute Abstinence From Cigarettes vs E-cigarettes (ENDS)VASP-SNCT06944847
Vaping and Smoking Project in People With Schizophrenia
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 will characterize withdrawal among people with schizophrenia who vape daily compared to people with schizophrenia who smoke combustible cigarettes daily, filling critical gaps in the understanding of electronic nicotine delivery systems (ENDS) dependence and contributing to the development of… Read more about this study
- Who is it for?
- Ages 21 to 50 years
- 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
- 64 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Feb 2025to 1 Apr 2027
- 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
- No healthy volunteers
- Adult
Who may be able to join
- 6+ months of daily/near-daily nicotine vaping or cigarette smoking
- 200+ ng/mL cotinine on a commercially-available quick screen
- stable antipsychotic medication dose (no changes in past 6 months).
- 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
Show all 11Show fewer
- 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
- pregnancy (intake urine screen)
- florid psychosis or severe cognitive symptoms (score of ≥5 on PANSS items delusions (P1), hallucinatory behavior (P3), or unusual thought content (G9), conceptual disorganization (P2), abstract thinking (N5), or poor attention (G11) or a score ≥6 on grandiosity (P5) or suspiciousness (P6)
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, 716-645-0192, lhawk@buffalo.edu
About this study
Official title: A Laboratory Study of Behavior and Performance Among People Who Vape Nicotine and/or Smoke Cigarettes - Schizophrenia Supplement
The proposed research will characterize withdrawal among people with schizophrenia who vape daily compared to people with schizophrenia who smoke combustible cigarettes daily, filling critical gaps in the understanding of electronic nicotine delivery systems (ENDS) dependence and contributing to the development of vaping cessation interventions amongst people with schizophrenia, the leading preventable cause of death in the US.
Read the detailed description
Although withdrawal is considered a key feature of nicotine/tobacco addiction that contributes to difficulty quitting smoking and likely electronic nicotine delivery systems (ENDS; e.g., electronic cigarettes), there is currently no research on ENDS withdrawal in people with schizophrenia. The proposed supplement will conduct a systematic and comprehensive characterization of withdrawal in a sample of people with SCZ who vape daily compared to those who smoke daily, filling gaps in our understanding of ENDS dependence/withdrawal for people with SCZ and contributing to the identification of intervention targets for ENDS use.
- 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 use 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 use 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 |
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 scores
Measured: 2.5 hours
Wisconsin Smoking Withdrawal Scale - anxiety 0.5
anxiety subscale scores
Measured: 0.5 hours
Wisconsin Smoking Withdrawal Scale - anxiety 2.5
anxiety subscale scores
Measured: 2.5 hours
Wisconsin Smoking Withdrawal Scale - sad 0.5
sadness subscale scores
Measured: 0.5 hours
Wisconsin Smoking Withdrawal Scale - sad 2.5
sadness subscale scores
Measured: 2.5 hours
Wisconsin Smoking Withdrawal Scale - conc 0.5
difficulty concentrating subscale scores
Measured: 0.5 hours
Wisconsin Smoking Withdrawal Scale - conc 2.5
difficulty concentrating subscale scores
Measured: 2.5 hours
Wisconsin Smoking Withdrawal Scale - sleep 0.5
sleep subscale scores
Measured: 0.5 hours
Wisconsin Smoking Withdrawal Scale - sleep 2.5
sleep subscale scores
Measured: 2.5 hours
Wisconsin Smoking Withdrawal Scale - appetite 0.5
appetite subscale scores
Measured: 0.5 hours
Wisconsin Smoking Withdrawal Scale - appetite 2.5
appetite subscale scores
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
single-item indicators of withdrawal facets
Measured: 0.5 hours
Minnesota Nicotine Withdrawal Scale 2.5
single-item indicators of withdrawal facets
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 PA 2.5
positive affect subscale score
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 NA 2.5
negative affect subscale score
Measured: 2.5 hours
Snaith-Hamilton Pleasure Scale 0.5
Total score
Measured: 0.5
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
Questionnaire on Smoking Urges - Brief 2.5
total craving score
Measured: 2.5
PhenX Toolkit Insomnia Severity Index 0.5
7-item scale, with coverage of perceived impairment and interference with daily functioning
Measured: 0.5
PhenX Toolkit Insomnia Severity Index 2.5
7-item scale, with coverage of perceived impairment and interference with daily functioning
Measured: 2.5 hours
Restlessness ratings 0.5
3-item scale
Measured: 0.5
Restlessness ratings 2.5
3-item scale
Measured: 2.5 hours
Restlessness and Agitation Questionnaire 2.5
11-item self-report scale total of behavioral indicators (supplemental evaluation of observer ratings)
Measured: 2.5 hours
Restlessness and Agitation Questionnaire 0.5
11-item self-report scale total of behavioral indicators (supplemental evaluation of observer ratings)
Measured: 0.5 hours
Identical Pairs 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: Lab visits: ~2 hours
n-back working memory task
The n-back task (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 (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 will be followed by 2 100-trial blocks of the 2- back. Accuracy is the primary outcome.
Measured: Lab visit ~ 2hours
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: Lab visits: ~2 hours
Spatial Delayed Response Task
The SDR is a brief delayed-response spatial working memory task in which the participant is presented with a series of 3 screens on each trial. Screen 1 presents a dot (target stimulus) presented for at 1 of 16 locations on the computer screen. Screen 2 presents a "distractor task" that entails a sham attention task, appearing for variable 5 or 30 second delay. The distractor task involves a series of shapes presented on the screen and participants are asked to click the spacebar on the keyboard when they see a diamond, until the delay is finished. Screen 3 prompts the subject to identify the location of the target stimulus presented on Screen 1 using the mouse. Participants are prompted to respond as fast as possible, the task does not progress until the location response is recorded. Note that because the SDR was previously not sensitive to nicotine abstinence in non-psychiatric controls (Sacco, et al., 2005), we will only assess SDR changes
Measured: 2 hours
kcal consumed
Fat, protein, and carbohydrate calories consumed
Measured: 3 hours
Hypothetical Commodity Purchase Tasks vaping intensity 0.5
intensity of demand
Measured: 0.5 hours
Hypothetical Commodity Purchase Tasks vaping intensity 2.5
intensity of demand
Measured: 2.5 hours
Hypothetical Commodity Purchase Tasks vaping persistence 0.5
persistence of demand
Measured: 0.5 hours
Hypothetical Commodity Purchase Tasks vaping persistence 2.5
persistence of demand
Measured: 2.5 hours
Hypothetical Commodity Purchase Tasks smoking intensity 0.5
intensity of demand
Measured: 0.5 hours
Hypothetical Commodity Purchase Tasks smoking intensity 2.5
intensity of demand
Measured: 2.5 hours
Hypothetical Commodity Purchase Tasks smoking persistence 0.5
persistence of demand
Measured: 0.5 hours
Hypothetical Commodity Purchase Tasks smoking persistence 2.5
persistence of demand
Measured: 2.5 hours
Positive and Negative Syndrome Scale positive 3
positive syndrome subscale
Measured: 3 hours
Positive and Negative Syndrome Scale negative 3
negative syndrome subscale
Measured: 3 hours
Positive and Negative Syndrome Scale general 3
general syndrome subscale
Measured: 3 hours
Secondary outcomes (10)
modified Cigarette evaluation questionnaire
Subjective/sensory effects of smoking expectancies will be assessed with widely used smoking measures (the modified Cigarette Evaluation Questionnaire, the short form of the Smoking Consequences Questionnaire, and the Smoking Abstinence Questionnaire) and adaptations and extensions of these measures for vaping.
Measured: 3.5 hours
modified e-Cigarette evaluation questionnaire
Subjective/sensory effects of vaping expectancies will be assessed with widely used smoking measures (the modified Cigarette Evaluation Questionnaire, the short form of the Smoking Consequences Questionnaire, and the Smoking Abstinence Questionnaire) and adaptations and extensions of these measures for vaping.
Measured: 3.5 hours
Somatic / side effect checklist 0.5
Assesses a range of somatic symptoms (e.g., headaches, fatigue)
Measured: 0.5 hours
Somatic / side effect checklist 2.5
Assesses a range of somatic symptoms (e.g., headaches, fatigue)
Measured: 2.5 hours
Heart rate 30
Heart rate, in beats per minute
Measured: 30 minutes
Heart rate 60
Heart rate, in beats per minute
Measured: 60 minutes
Heart rate 90
Heart rate, in beats per minute
Measured: 90 minutes
Heart rate 120
Heart rate, in beats per minute
Measured: 120 minutes
Heart rate 150
Heart rate, in beats per minute
Measured: 150 minutes
Heart rate 180
Heart rate, in beats per minute
Measured: 180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start15 Feb 2025
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (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.
- More trials run by State University of New York at BuffaloThe sponsor's other registered studies.
- 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
- 64 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
- NCT06944847
- Sponsor's protocol ID
- STUDY00006122-Supplement
- Other IDs
- 3R01DA054276-03S1
- Acronym
- VASP-S
- Status last verified
- Mar 2026
- First submitted
- 6 Apr 2025
- 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 Laboratory Study of Behavior and Performance Among People Who Vape Nicotine and/or Smoke Cigarettes - Schizophrenia Supplement
- ClinicalTrials.gov ID
- NCT06944847
- Acronym / sponsor ID
- VASP-S / STUDY00006122-Supplement
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 64 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
- 15 Feb 2025 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 25 Apr 2025 (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 will characterize withdrawal among people with schizophrenia who vape daily compared to people with schizophrenia who smoke combustible cigarettes daily, filling critical gaps in the understanding of electronic nicotine delivery systems (ENDS) dependence and contributing to the development of vaping cessation interventions amongst people with schizophrenia, the leading preventable cause of death in the US.
Detailed description
Although withdrawal is considered a key feature of nicotine/tobacco addiction that contributes to difficulty quitting smoking and likely electronic nicotine delivery systems (ENDS; e.g., electronic cigarettes), there is currently no research on ENDS withdrawal in people with schizophrenia. The proposed supplement will conduct a systematic and comprehensive characterization of withdrawal in a sample of people with SCZ who vape daily compared to those who smoke daily, filling gaps in our understanding of ENDS dependence/withdrawal for people with SCZ and contributing to the identification of intervention targets for ENDS use.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All participants will complete two visits, one following 24-hour abstinence, the other while smoking/vaping as usual.
| Arm | Type | Receives |
|---|---|---|
| Daily use 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 use 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. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 6+ months of daily/near-daily nicotine vaping or cigarette smoking
- 200+ ng/mL cotinine on a commercially-available quick screen
- stable antipsychotic medication dose (no changes in past 6 months).
- 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
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 use of ENDS, Daily use of combustible cigarettes |
| Ad libitum smoking/vapingParticipants will be asked to smoke/vape as usual during the 24 hours prior to the visit | Behavioural | Daily use of ENDS, Daily use of combustible cigarettes |
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 scores
Wisconsin Smoking Withdrawal Scale - anxiety 0.5
Time frame: 0.5 hours
anxiety subscale scores
Wisconsin Smoking Withdrawal Scale - anxiety 2.5
Time frame: 2.5 hours
anxiety subscale scores
Wisconsin Smoking Withdrawal Scale - sad 0.5
Time frame: 0.5 hours
sadness subscale scores
Wisconsin Smoking Withdrawal Scale - sad 2.5
Time frame: 2.5 hours
sadness subscale scores
Wisconsin Smoking Withdrawal Scale - conc 0.5
Time frame: 0.5 hours
difficulty concentrating subscale scores
Wisconsin Smoking Withdrawal Scale - conc 2.5
Time frame: 2.5 hours
difficulty concentrating subscale scores
Wisconsin Smoking Withdrawal Scale - sleep 0.5
Time frame: 0.5 hours
sleep subscale scores
Wisconsin Smoking Withdrawal Scale - sleep 2.5
Time frame: 2.5 hours
sleep subscale scores
Wisconsin Smoking Withdrawal Scale - appetite 0.5
Time frame: 0.5 hours
appetite subscale scores
Wisconsin Smoking Withdrawal Scale - appetite 2.5
Time frame: 2.5 hours
appetite subscale scores
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
single-item indicators of withdrawal facets
Minnesota Nicotine Withdrawal Scale 2.5
Time frame: 2.5 hours
single-item indicators of withdrawal facets
Positive and Negative Affect Scale NA 0.5
Time frame: 0.5 hours
negative 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 PA 0.5
Time frame: 0.5 hours
positive 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
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
total craving score
Questionnaire on Smoking Urges - Brief 2.5
Time frame: 2.5
total craving score
PhenX Toolkit Insomnia Severity Index 0.5
Time frame: 0.5
7-item scale, with coverage of perceived impairment and interference with daily functioning
PhenX Toolkit Insomnia Severity Index 2.5
Time frame: 2.5 hours
7-item scale, with coverage of perceived impairment and interference with daily functioning
Restlessness ratings 0.5
Time frame: 0.5
3-item scale
Restlessness ratings 2.5
Time frame: 2.5 hours
3-item scale
Restlessness and Agitation Questionnaire 2.5
Time frame: 2.5 hours
11-item self-report scale total of behavioral indicators (supplemental evaluation of observer ratings)
Restlessness and Agitation Questionnaire 0.5
Time frame: 0.5 hours
11-item self-report scale total of behavioral indicators (supplemental evaluation of observer ratings)
Identical Pairs Continuous Performance Task
Time frame: Lab visits: ~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: Lab visit ~ 2hours
The n-back task (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 (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 will be followed by 2 100-trial blocks of the 2- back. Accuracy is the primary outcome.
Stop signal reaction time task
Time frame: Lab visits: ~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.
Spatial Delayed Response Task
Time frame: 2 hours
The SDR is a brief delayed-response spatial working memory task in which the participant is presented with a series of 3 screens on each trial. Screen 1 presents a dot (target stimulus) presented for at 1 of 16 locations on the computer screen. Screen 2 presents a "distractor task" that entails a sham attention task, appearing for variable 5 or 30 second delay. The distractor task involves a series of shapes presented on the screen and participants are asked to click the spacebar on the keyboard when they see a diamond, until the delay is finished. Screen 3 prompts the subject to identify the location of the target stimulus presented on Screen 1 using the mouse. Participants are prompted to respond as fast as possible, the task does not progress until the location response is recorded. Note that because the SDR was previously not sensitive to nicotine abstinence in non-psychiatric controls (Sacco, et al., 2005), we will only assess SDR changes
kcal consumed
Time frame: 3 hours
Fat, protein, and carbohydrate calories consumed
Hypothetical Commodity Purchase Tasks vaping intensity 0.5
Time frame: 0.5 hours
intensity of demand
Hypothetical Commodity Purchase Tasks vaping intensity 2.5
Time frame: 2.5 hours
intensity of demand
Hypothetical Commodity Purchase Tasks vaping persistence 0.5
Time frame: 0.5 hours
persistence of demand
Hypothetical Commodity Purchase Tasks vaping persistence 2.5
Time frame: 2.5 hours
persistence of demand
Hypothetical Commodity Purchase Tasks smoking intensity 0.5
Time frame: 0.5 hours
intensity of demand
Hypothetical Commodity Purchase Tasks smoking intensity 2.5
Time frame: 2.5 hours
intensity of demand
Hypothetical Commodity Purchase Tasks smoking persistence 0.5
Time frame: 0.5 hours
persistence of demand
Hypothetical Commodity Purchase Tasks smoking persistence 2.5
Time frame: 2.5 hours
persistence of demand
Positive and Negative Syndrome Scale positive 3
Time frame: 3 hours
positive syndrome subscale
Positive and Negative Syndrome Scale negative 3
Time frame: 3 hours
negative syndrome subscale
Positive and Negative Syndrome Scale general 3
Time frame: 3 hours
general syndrome subscale
10 secondary outcomes
modified Cigarette evaluation questionnaire
Time frame: 3.5 hours
modified e-Cigarette evaluation questionnaire
Time frame: 3.5 hours
Somatic / side effect checklist 0.5
Time frame: 0.5 hours
Somatic / side effect checklist 2.5
Time frame: 2.5 hours
Heart rate 30
Time frame: 30 minutes
Heart rate 60
Time frame: 60 minutes
Heart rate 90
Time frame: 90 minutes
Heart rate 120
Time frame: 120 minutes
Heart rate 150
Time frame: 150 minutes
Heart rate 180
Time frame: 180 minutes
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 Withdrawal Project
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 11 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 48 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.