NCT06944847 · State University of New York at Buffalo
Vaping and Smoking Project in People With Schizophrenia
(VASP-S)
What this study is about
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.
View original scientific description
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.
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 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
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 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
- 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)
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