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NCT Number: NCT06944847

Vaping and Smoking Project in People With Schizophrenia

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.

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Key information

Age range

21 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University at Buffalo

Buffalo, New York, 14260, United States

Location status: Recruiting

Location contact

Larry Hawk, PhD

CONTACT

[email protected]

716-645-0192

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Acute (24-hour) abstinence

Behavioral

Participants will be asked to abstain from all tobacco/nicotine for 24 hours prior to the visit

Ad libitum smoking/vaping

Behavioral

Participants will be asked to smoke/vape as usual during the 24 hours prior to the visit

Primary outcomes

  1. Wisconsin Smoking Withdrawal Scale - anger 0.5

    Time frame: 0.5 hours

    anger subscale score

  2. Wisconsin Smoking Withdrawal Scale - anger 2.5

    Time frame: 2.5 hours

    anger subscale scores

  3. Wisconsin Smoking Withdrawal Scale - anxiety 0.5

    Time frame: 0.5 hours

    anxiety subscale scores

  4. Wisconsin Smoking Withdrawal Scale - anxiety 2.5

    Time frame: 2.5 hours

    anxiety subscale scores

  5. Wisconsin Smoking Withdrawal Scale - sad 0.5

    Time frame: 0.5 hours

    sadness subscale scores

  6. Wisconsin Smoking Withdrawal Scale - sad 2.5

    Time frame: 2.5 hours

    sadness subscale scores

  7. Wisconsin Smoking Withdrawal Scale - conc 0.5

    Time frame: 0.5 hours

    difficulty concentrating subscale scores

  8. Wisconsin Smoking Withdrawal Scale - conc 2.5

    Time frame: 2.5 hours

    difficulty concentrating subscale scores

  9. Wisconsin Smoking Withdrawal Scale - sleep 0.5

    Time frame: 0.5 hours

    sleep subscale scores

  10. Wisconsin Smoking Withdrawal Scale - sleep 2.5

    Time frame: 2.5 hours

    sleep subscale scores

  11. Wisconsin Smoking Withdrawal Scale - appetite 0.5

    Time frame: 0.5 hours

    appetite subscale scores

  12. Wisconsin Smoking Withdrawal Scale - appetite 2.5

    Time frame: 2.5 hours

    appetite subscale scores

  13. Mood and Physical Symptoms Scale 0.5

    Time frame: 0.5 hours

    single-item indicators of withdrawal facets

  14. Mood and Physical Symptoms Scale 2.5

    Time frame: 2.5 hours

    single-item indicators of withdrawal facets

  15. Minnesota Nicotine Withdrawal Scale 0.5

    Time frame: 0.5 hours

    single-item indicators of withdrawal facets

  16. Minnesota Nicotine Withdrawal Scale 2.5

    Time frame: 2.5 hours

    single-item indicators of withdrawal facets

  17. Positive and Negative Affect Scale NA 0.5

    Time frame: 0.5 hours

    negative affect subscale score

  18. Positive and Negative Affect Scale PA 2.5

    Time frame: 2.5 hours

    positive affect subscale score

  19. Positive and Negative Affect Scale PA 0.5

    Time frame: 0.5 hours

    positive affect subscale score

  20. Positive and Negative Affect Scale NA 2.5

    Time frame: 2.5 hours

    negative affect subscale score

  21. Snaith-Hamilton Pleasure Scale 0.5

    Time frame: 0.5

    Total score

  22. Snaith-Hamilton Pleasure Scale 2.5

    Time frame: 2.5 hours

    Total score

  23. Questionnaire on Vaping Craving 0.5

    Time frame: 0.5 hours

    total craving score

  24. Questionnaire on Vaping Craving 2.5

    Time frame: 2.5 hours

    total craving score

  25. Questionnaire on Smoking Urges - Brief 0.5

    Time frame: 0.5

    total craving score

  26. Questionnaire on Smoking Urges - Brief 2.5

    Time frame: 2.5

    total craving score

  27. PhenX Toolkit Insomnia Severity Index 0.5

    Time frame: 0.5

    7-item scale, with coverage of perceived impairment and interference with daily functioning

  28. 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

  29. Restlessness ratings 0.5

    Time frame: 0.5

    3-item scale

  30. Restlessness ratings 2.5

    Time frame: 2.5 hours

    3-item scale

  31. 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)

  32. 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)

  33. 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.

  34. 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.

  35. 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.

  36. 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

  37. kcal consumed

    Time frame: 3 hours

    Fat, protein, and carbohydrate calories consumed

  38. Hypothetical Commodity Purchase Tasks vaping intensity 0.5

    Time frame: 0.5 hours

    intensity of demand

  39. Hypothetical Commodity Purchase Tasks vaping intensity 2.5

    Time frame: 2.5 hours

    intensity of demand

  40. Hypothetical Commodity Purchase Tasks vaping persistence 0.5

    Time frame: 0.5 hours

    persistence of demand

  41. Hypothetical Commodity Purchase Tasks vaping persistence 2.5

    Time frame: 2.5 hours

    persistence of demand

  42. Hypothetical Commodity Purchase Tasks smoking intensity 0.5

    Time frame: 0.5 hours

    intensity of demand

  43. Hypothetical Commodity Purchase Tasks smoking intensity 2.5

    Time frame: 2.5 hours

    intensity of demand

  44. Hypothetical Commodity Purchase Tasks smoking persistence 0.5

    Time frame: 0.5 hours

    persistence of demand

  45. Hypothetical Commodity Purchase Tasks smoking persistence 2.5

    Time frame: 2.5 hours

    persistence of demand

  46. Positive and Negative Syndrome Scale positive 3

    Time frame: 3 hours

    positive syndrome subscale

  47. Positive and Negative Syndrome Scale negative 3

    Time frame: 3 hours

    negative syndrome subscale

  48. Positive and Negative Syndrome Scale general 3

    Time frame: 3 hours

    general syndrome subscale

Secondary outcomes

  1. modified Cigarette evaluation questionnaire

    Time frame: 3.5 hours

    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.

  2. modified e-Cigarette evaluation questionnaire

    Time frame: 3.5 hours

    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. Somatic / side effect checklist 0.5

    Time frame: 0.5 hours

    Assesses a range of somatic symptoms (e.g., headaches, fatigue)

  4. Somatic / side effect checklist 2.5

    Time frame: 2.5 hours

    Assesses a range of somatic symptoms (e.g., headaches, fatigue)

  5. Heart rate 30

    Time frame: 30 minutes

    Heart rate, in beats per minute

  6. Heart rate 60

    Time frame: 60 minutes

    Heart rate, in beats per minute

  7. Heart rate 90

    Time frame: 90 minutes

    Heart rate, in beats per minute

  8. Heart rate 120

    Time frame: 120 minutes

    Heart rate, in beats per minute

  9. Heart rate 150

    Time frame: 150 minutes

    Heart rate, in beats per minute

  10. Heart rate 180

    Time frame: 180 minutes

    Heart rate, in beats per minute

Other outcomes

  1. Cotinine

    Time frame: 0.25 hours

    assay cotinine from urine sample collected at the start of each visit in order to assess the degree of compliance with the abstinence manipulation

  2. Expired-air carbon monoxide

    Time frame: 0.25 hours

    biochemical measure related to past 24-hour smoking

Study contacts

Contact information is provided by the study sponsor or research team.

Larry Hawk, PhD

CONTACT

[email protected]

716-645-0192

Sponsors and collaborators

Lead sponsor

State University of New York at Buffalo

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)
  • Roswell Park Cancer Institute

Registry information

Official study title

A Laboratory Study of Behavior and Performance Among People Who Vape Nicotine and/or Smoke Cigarettes - Schizophrenia Supplement

Acronym: VASP-S

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Apr 25, 2025
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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