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. 2021 Sep 14;2021(9):CD010216. doi: 10.1002/14651858.CD010216.pub6

NCT04452175.

Study name Official title: Cigarette consumption after switchinG to high or low Nicotine strENght E‐cigaretteS In Smokers with Schizophrenia spectrum disorders: a 12‐month randomized, double‐blind multicentre trial
Brief title: Cigarette consumption after switchinG to high or low nicotine strENght E‐cigaretteS In Smokers with Schizophrenia (GENESIS)
Methods RCT
Multicenter: Italy, Russia, Ukraine, UK
Collaborators:
  • Juul Labs, Inc.

  • St. Petersburg State Pavlov Medical University

  • Bashkir State Medical University

  • Ukrainian Institute on Public Health Policy

  • University of Surrey

  • Eclat Srl

Participants Estimated enrolment: 260
Inclusion criteria:
  • Adult (> 18 yrs)

  • Regular smoking (> 10 cigarettes a day; for at least 1 year)

  • Exhaled breath CO (eCO) level > 7 ppm

  • Not currently attempting to quit smoking or wishing to do so in the next 30 days; this will be verified at screening by the answer ''NO'' to the question ''Do you intend to quit in the next 30 days?''

  • Schizophrenia spectrum disorder diagnosis (schizophrenia, delusional disorder, schizoaffective disorder, personality disorder, schizoid personality disorder, etc) by DSM‐V criteria

  • Understand and provide informed consent

  • Able to comply with all study procedures


Exclusion criteria:
  • Institutionalized patients

  • Acute decompensation of Schizophrenia spectrum disorder symptoms within the past month

  • Change in antipsychotic treatment within the past month

  • No recent history of hospitalization for any serious medical condition within 3 months prior to screening, as determined by the investigator

  • Myocardial infarction or angina pectoris within 3 months prior to screening, as determined by the investigator

  • Current poorly‐controlled asthma or COPD

  • Pregnancy, planned pregnancy or breastfeeding. Any female participant who becomes pregnant during this study will be withdrawn

  • People who have a significant history of alcoholism or drug/chemical abuse within 12 months prior to screening, as determined by the investigator.

  • Accepting to take part in a smoking cessation program

  • People who regularly use any recreational nicotine (e.g. e‐cigarettes,) or tobacco product (e.g. tobacco heated products, oral smokeless) other than their own cigarettes within 30 days of screening

  • People who have used smoking cessation therapies (e.g. varenicline, bupropion, or NRT) within 30 days of screening

  • People who are still participating in another clinical study (e.g. attending follow‐up visits) or who have recently participated in a clinical study involving administration of an investigational drug (new chemical entity) within the past 3 months

  • People who have, or who have a history of, any clinically‐significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, hematological or other major disorder that, in the opinion of the investigator or their appropriately qualified designee, would jeopardize the safety of the participant or impact on the validity of the study results

Interventions
  • Experimental: HIGH 5%. Intervention: JUUL E‐CIGARETTE

  • Active Comparator: LOW 1.7%. Intervention: JUUL E‐CIGARETTE

Outcomes Primary outcomes:
  • Rates of participants with continuous smoking abstinence at 6 months; Time Frame: 24 weeks

  • Self‐reported continuous smoking abstinence at 6 months from the previous visit, biochemically‐verified by exhaled CO measurements of ≤ 7 ppm


Secondary outcomes
  • Rates of participants with continuous smoking abstinence at 12‐month [ Time Frame: 52 weeks ]

  • Rates of participants with continuous smoking reduction at 6‐month [ Time Frame: 24 weeks]

  • Rates of participants with continuous smoking reduction at 12‐month [ Time Frame: 52 weeks]

  • Proportion of AEs [ Time Frame: 24 weeks]

  • Absolute change in PANSS [ Time Frame: 24 weeks]

  • Absolute change in mCEQ [ Time Frame: 24 weeks]

  • Absolute change in Chester Step Test‐derived values [ Time Frame: 24 weeks]

  • Change in App‐derived endpoints (self‐rated mental health ‐SRMH). [ Time Frame: 24 weeks]

Starting date October 2020. Estimated completion date March 2022
Contact information Pasquale Caponnetto, p.caponnetto@unict.it
Notes