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Recruiting NCT06944847

Vaping and Smoking Project in People With Schizophrenia

No phase Interventional Acute Abstinence From Cigarettes vs E-cigarettes (ENDS)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Acute (24-hour) abstinence, Ad libitum smoking/vaping.
Who it may be relevant to
Registry conditions: Acute Abstinence From Cigarettes vs E-cigarettes (ENDS). Basic parameters: 21 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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]
  • Wisconsin Smoking Withdrawal Scale - anger 2.5 [Time frame: 2.5 hours]
  • Wisconsin Smoking Withdrawal Scale - anxiety 0.5 [Time frame: 0.5 hours]
  • Wisconsin Smoking Withdrawal Scale - anxiety 2.5 [Time frame: 2.5 hours]
  • Wisconsin Smoking Withdrawal Scale - sad 0.5 [Time frame: 0.5 hours]
  • Wisconsin Smoking Withdrawal Scale - sad 2.5 [Time frame: 2.5 hours]
  • Wisconsin Smoking Withdrawal Scale - conc 0.5 [Time frame: 0.5 hours]
  • Wisconsin Smoking Withdrawal Scale - conc 2.5 [Time frame: 2.5 hours]
  • Wisconsin Smoking Withdrawal Scale - sleep 0.5 [Time frame: 0.5 hours]
  • Wisconsin Smoking Withdrawal Scale - sleep 2.5 [Time frame: 2.5 hours]
Secondary outcome measures (10)
  • 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]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • University at Buffalo — Buffalo

Identifiers

NCT: NCT06944847 · STUDY00006122-Supplement · 3R01DA054276-03S1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗