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Vaping and Smoking Project in People With Schizophrenia

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
21 Years to 50 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study compares symptoms people have when they stop using nicotine, called withdrawal. It is for people with schizophrenia who vape nicotine or smoke cigarettes daily. The findings may help develop ways to help people with schizophrenia quit vaping.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have vaped nicotine or smoked cigarettes daily or almost daily for at least 6 months.
  • Have a quick test showing a cotinine level of at least 200 ng/mL. Cotinine is a substance your body makes when it breaks down nicotine.
  • Have had no dose changes to your antipsychotic medicine in the past 6 months. This medicine treats symptoms of schizophrenia.

Who can't join

  • Plan to quit daily or almost daily vaping or smoking in the next month.
  • Used pipe tobacco, hookah or shisha, smokeless tobacco, dissolvable tobacco, or nicotine pouches on 2 or more days in the past 7 days.
  • For the vaping group only: used cigars, cigarillos, or filtered cigars containing tobacco or tobacco mixed with marijuana on 2 or more days in the past 7 days.
  • Currently use any medicine to help you quit smoking.
  • Currently have severe dependence on a substance other than tobacco or nicotine, including marijuana, with a score of 27 or higher on the study's substance-use screening test.
  • Had thoughts of suicide with an intent or plan to act on them in the past 2 weeks.
  • Are pregnant, based on a urine test at the first visit.
  • Have severe symptoms of psychosis or problems with thinking, based on the study's rating scale. These may include seeing or hearing things others do not, false beliefs, confused thinking, poor attention, feeling unusually powerful, or strong distrust of others.

Simplified for readability. The official criteria below are what the study team uses.

Official 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)

Study sites (1)

NY