Clinical trial NCT06944847: Vaping and Smoking Project in People With Schizophrenia
Official title: A Laboratory Study of Behavior and Performance Among People Who Vape Nicotine and/or Smoke Cigarettes - Schizophrenia Supplement
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Abstinence From Cigarettes vs E-cigarettes (ENDS)
Lead sponsor: State University of New York at Buffalo
Sponsor class: OTHER
Collaborators: name: Roswell Park Cancer Institute
name: National Institute on Drug Abuse (NIDA)
First posted: 2025-04-25
Enrollment: 64
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: All participants will complete two visits, one following 24-hour abstinence, the other while smoking/vaping as usual.
Primary purpose: BASIC_SCIENCE

Brief 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 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Wisconsin Smoking Withdrawal Scale - anger 0.5
timeFrame: 0.5 hours
measure: Wisconsin Smoking Withdrawal Scale - anger 2.5
timeFrame: 2.5 hours
measure: Wisconsin Smoking Withdrawal Scale - anxiety 0.5
timeFrame: 0.5 hours
measure: Wisconsin Smoking Withdrawal Scale - anxiety 2.5
timeFrame: 2.5 hours
measure: Wisconsin Smoking Withdrawal Scale - sad 0.5
timeFrame: 0.5 hours
measure: Wisconsin Smoking Withdrawal Scale - sad 2.5
timeFrame: 2.5 hours
measure: Wisconsin Smoking Withdrawal Scale - conc 0.5
timeFrame: 0.5 hours
measure: Wisconsin Smoking Withdrawal Scale - conc 2.5
timeFrame: 2.5 hours
measure: Wisconsin Smoking Withdrawal Scale - sleep 0.5
timeFrame: 0.5 hours
measure: Wisconsin Smoking Withdrawal Scale - sleep 2.5
timeFrame: 2.5 hours
measure: Wisconsin Smoking Withdrawal Scale - appetite 0.5
timeFrame: 0.5 hours
measure: Wisconsin Smoking Withdrawal Scale - appetite 2.5
timeFrame: 2.5 hours
measure: Mood and Physical Symptoms Scale 0.5
timeFrame: 0.5 hours
measure: Mood and Physical Symptoms Scale 2.5
timeFrame: 2.5 hours
measure: Minnesota Nicotine Withdrawal Scale 0.5
timeFrame: 0.5 hours
measure: Minnesota Nicotine Withdrawal Scale 2.5
timeFrame: 2.5 hours
measure: Positive and Negative Affect Scale NA 0.5
timeFrame: 0.5 hours
measure: Positive and Negative Affect Scale PA 2.5
timeFrame: 2.5 hours
measure: Positive and Negative Affect Scale PA 0.5
timeFrame: 0.5 hours
measure: Positive and Negative Affect Scale NA 2.5
timeFrame: 2.5 hours
measure: Snaith-Hamilton Pleasure Scale 0.5
timeFrame: 0.5
measure: Snaith-Hamilton Pleasure Scale 2.5
timeFrame: 2.5 hours
measure: Questionnaire on Vaping Craving 0.5
timeFrame: 0.5 hours
measure: Questionnaire on Vaping Craving 2.5
timeFrame: 2.5 hours
measure: Questionnaire on Smoking Urges - Brief 0.5
timeFrame: 0.5
measure: Questionnaire on Smoking Urges - Brief 2.5
timeFrame: 2.5
measure: PhenX Toolkit Insomnia Severity Index 0.5
timeFrame: 0.5
measure: PhenX Toolkit Insomnia Severity Index 2.5
timeFrame: 2.5 hours
measure: Restlessness ratings 0.5
timeFrame: 0.5
measure: Restlessness ratings 2.5
timeFrame: 2.5 hours
measure: Restlessness and Agitation Questionnaire 2.5
timeFrame: 2.5 hours
measure: Restlessness and Agitation Questionnaire 0.5
timeFrame: 0.5 hours
measure: Identical Pairs Continuous Performance Task
timeFrame: Lab visits: ~2 hours
measure: n-back working memory task
timeFrame: Lab visit ~ 2hours
measure: Stop signal reaction time task
timeFrame: Lab visits: ~2 hours
measure: Spatial Delayed Response Task
timeFrame: 2 hours
measure: kcal consumed
timeFrame: 3 hours
measure: Hypothetical Commodity Purchase Tasks vaping intensity 0.5
timeFrame: 0.5 hours
measure: Hypothetical Commodity Purchase Tasks vaping intensity 2.5
timeFrame: 2.5 hours
measure: Hypothetical Commodity Purchase Tasks vaping persistence 0.5
timeFrame: 0.5 hours
measure: Hypothetical Commodity Purchase Tasks vaping persistence 2.5
timeFrame: 2.5 hours
measure: Hypothetical Commodity Purchase Tasks smoking intensity 0.5
timeFrame: 0.5 hours
measure: Hypothetical Commodity Purchase Tasks smoking intensity 2.5
timeFrame: 2.5 hours
measure: Hypothetical Commodity Purchase Tasks smoking persistence 0.5
timeFrame: 0.5 hours
measure: Hypothetical Commodity Purchase Tasks smoking persistence 2.5
timeFrame: 2.5 hours
measure: Positive and Negative Syndrome Scale positive 3
timeFrame: 3 hours
measure: Positive and Negative Syndrome Scale negative 3
timeFrame: 3 hours
measure: Positive and Negative Syndrome Scale general 3
timeFrame: 3 hours
Secondary outcomes:
measure: modified Cigarette evaluation questionnaire
timeFrame: 3.5 hours
measure: modified e-Cigarette evaluation questionnaire
timeFrame: 3.5 hours
measure: Somatic / side effect checklist 0.5
timeFrame: 0.5 hours
measure: Somatic / side effect checklist 2.5
timeFrame: 2.5 hours
measure: Heart rate 30
timeFrame: 30 minutes
measure: Heart rate 60
timeFrame: 60 minutes
measure: Heart rate 90
timeFrame: 90 minutes
measure: Heart rate 120
timeFrame: 120 minutes
measure: Heart rate 150
timeFrame: 150 minutes
measure: Heart rate 180
timeFrame: 180 minutes
Other outcomes:
measure: Cotinine
timeFrame: 0.25 hours
measure: Expired-air carbon monoxide
timeFrame: 0.25 hours
Locations:
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: University at Buffalo
name: Larry Hawk, PhD
role: PRINCIPAL_INVESTIGATOR
References: