Vaping and Smoking Project in People With Schizophrenia (VASP-S)

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Abstinence From Cigarettes vs E-cigarettes (ENDS)
• Intervention / Treatment: Behavioral: Acute (24-hour) abstinence; Behavioral: Ad libitum smoking/vaping

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 Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Larry Hawk, PhD; Phone Number: 716-645-0192; Email: lhawk@buffalo.edu

Study Locations

• United States
  • New York
    • Buffalo, New York, United States, 14260
      • Recruiting
      • University at Buffalo
      • Contact: Larry Hawk, PhD; Phone Number: 716-645-0192; Email: lhawk@buffalo.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Daily use of ENDS; Participants who use nicotine-containing ENDS daily or near-daily but who do NOT smoke combustible cigarettes daily or near-daily.	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
Other: Daily use of combustible cigarettes; Participants who smoke combustible cigarettes daily or near-daily but do NOT use nicotine-containing ENDS daily or near-daily.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wisconsin Smoking Withdrawal Scale - anger 0.5	anger subscale score	0.5 hours
Questionnaire on Vaping Craving 0.5	total craving score	0.5 hours
Questionnaire on Vaping Craving 2.5	total craving score	2.5 hours
Restlessness ratings 2.5	3-item scale	2.5 hours
Wisconsin Smoking Withdrawal Scale - anger 2.5	anger subscale scores	2.5 hours
Wisconsin Smoking Withdrawal Scale - anxiety 0.5	anxiety subscale scores	0.5 hours
Wisconsin Smoking Withdrawal Scale - anxiety 2.5	anxiety subscale scores	2.5 hours
Wisconsin Smoking Withdrawal Scale - sad 0.5	sadness subscale scores	0.5 hours
Wisconsin Smoking Withdrawal Scale - sad 2.5	sadness subscale scores	2.5 hours
Wisconsin Smoking Withdrawal Scale - conc 0.5	difficulty concentrating subscale scores	0.5 hours
Wisconsin Smoking Withdrawal Scale - conc 2.5	difficulty concentrating subscale scores	2.5 hours
Wisconsin Smoking Withdrawal Scale - sleep 0.5	sleep subscale scores	0.5 hours
Wisconsin Smoking Withdrawal Scale - sleep 2.5	sleep subscale scores	2.5 hours
Wisconsin Smoking Withdrawal Scale - appetite 0.5	appetite subscale scores	0.5 hours
Wisconsin Smoking Withdrawal Scale - appetite 2.5	appetite subscale scores	2.5 hours
Mood and Physical Symptoms Scale 0.5	single-item indicators of withdrawal facets	0.5 hours
Mood and Physical Symptoms Scale 2.5	single-item indicators of withdrawal facets	2.5 hours
Minnesota Nicotine Withdrawal Scale 0.5	single-item indicators of withdrawal facets	0.5 hours
Minnesota Nicotine Withdrawal Scale 2.5	single-item indicators of withdrawal facets	2.5 hours
Positive and Negative Affect Scale NA 0.5	negative affect subscale score	0.5 hours
Positive and Negative Affect Scale PA 2.5	positive affect subscale score	2.5 hours
Positive and Negative Affect Scale PA 0.5	positive affect subscale score	0.5 hours
Positive and Negative Affect Scale NA 2.5	negative affect subscale score	2.5 hours
Snaith-Hamilton Pleasure Scale 0.5	Total score	0.5
Snaith-Hamilton Pleasure Scale 2.5	Total score	2.5 hours
Questionnaire on Smoking Urges - Brief 0.5	total craving score	0.5
Questionnaire on Smoking Urges - Brief 2.5	total craving score	2.5
PhenX Toolkit Insomnia Severity Index 0.5	7-item scale, with coverage of perceived impairment and interference with daily functioning	0.5
PhenX Toolkit Insomnia Severity Index 2.5	7-item scale, with coverage of perceived impairment and interference with daily functioning	2.5 hours
Restlessness ratings 0.5	3-item scale	0.5
Restlessness and Agitation Questionnaire 2.5	11-item self-report scale total of behavioral indicators (supplemental evaluation of observer ratings)	2.5 hours
Restlessness and Agitation Questionnaire 0.5	11-item self-report scale total of behavioral indicators (supplemental evaluation of observer ratings)	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.	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.	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.	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	2 hours
kcal consumed	Fat, protein, and carbohydrate calories consumed	3 hours
Hypothetical Commodity Purchase Tasks vaping intensity 0.5	intensity of demand	0.5 hours
Hypothetical Commodity Purchase Tasks vaping intensity 2.5	intensity of demand	2.5 hours
Hypothetical Commodity Purchase Tasks vaping persistence 0.5	persistence of demand	0.5 hours
Hypothetical Commodity Purchase Tasks vaping persistence 2.5	persistence of demand	2.5 hours
Hypothetical Commodity Purchase Tasks smoking intensity 0.5	intensity of demand	0.5 hours
Hypothetical Commodity Purchase Tasks smoking intensity 2.5	intensity of demand	2.5 hours
Hypothetical Commodity Purchase Tasks smoking persistence 0.5	persistence of demand	0.5 hours
Hypothetical Commodity Purchase Tasks smoking persistence 2.5	persistence of demand	2.5 hours
Positive and Negative Syndrome Scale positive 3	positive syndrome subscale	3 hours
Positive and Negative Syndrome Scale negative 3	negative syndrome subscale	3 hours
Positive and Negative Syndrome Scale general 3	general syndrome subscale	3 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	3.5 hours
Somatic / side effect checklist 0.5	Assesses a range of somatic symptoms (e.g., headaches, fatigue)	0.5 hours
Somatic / side effect checklist 2.5	Assesses a range of somatic symptoms (e.g., headaches, fatigue)	2.5 hours
Heart rate 30	Heart rate, in beats per minute	30 minutes
Heart rate 60	Heart rate, in beats per minute	60 minutes
Heart rate 90	Heart rate, in beats per minute	90 minutes
Heart rate 120	Heart rate, in beats per minute	120 minutes
Heart rate 150	Heart rate, in beats per minute	150 minutes
Heart rate 180	Heart rate, in beats per minute	180 minutes

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cotinine	assay cotinine from urine sample collected at the start of each visit in order to assess the degree of compliance with the abstinence manipulation	0.25 hours
Expired-air carbon monoxide	biochemical measure related to past 24-hour smoking	0.25 hours

Collaborators and Investigators

• Sponsor: State University of New York at Buffalo
• Collaborators: National Institute on Drug Abuse (NIDA); Roswell Park Cancer Institute
• Investigators: Principal Investigator: Larry Hawk, PhD, University at Buffalo

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: April 6, 2025
• First Submitted That Met QC Criteria: April 17, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; Manufactured Materials; Technology, Industry, and Agriculture; Smoking Devices; Electronic Nicotine Delivery Systems
• Other Study ID Numbers: STUDY00006122-Supplement; 3R01DA054276-03S1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We plan to make the full de-identified data set with metadata available through the National Addiction and HIV Data Archive Program (NAHDAP).
• IPD Sharing Time Frame: Data will be shared at approximately the same time as the acceptance for publication of the main findings from the final dataset. The dataset will have a permanent digital object identifier and will be available as long as the NAHDAP is available.
• IPD Sharing Access Criteria: Per NAHDAP
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No