Status:
RECRUITING
Cigarette Consumption After switchinG to High or Low Nicotine strENght E-cigaretteS In Smokers With Schizophrenia
Lead Sponsor:
University of Catania
Collaborating Sponsors:
Juul Labs, Inc.
St. Petersburg State Pavlov Medical University
Conditions:
Smoking
Schizophrenia Spectrum and Other Psychotic Disorders
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Smokers with schizophrenia spectrum disorders have high rates of morbidity and mortality from smoking-related diseases compared with the general population and current options for smoking cessation in...
Detailed Description
Multicenter, 12-months prospective trial, utilizing a randomized, double-blind, 2-arm parallel, switching design to compare effectiveness, tolerability, acceptability, and pattern of use between high ...
Eligibility Criteria
Inclusion
- Adult (\>18yrs)
- Regular smoking (\>10 cigarettes a day; for at least one 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
- 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 Any female participant who becomes pregnant during this study will be withdrawn.
- Participants 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
- Participants 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.
- Participants who have used smoking cessation therapies (e.g varenecline, buproprion, or NRT) within 30 days of screening.
- Participants 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.
- Participants who have, or who have a history of, any clinically-significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorder that, in the opinion of the investigator or their appropriately qualified designee, would jeopardise the safety of the participant or impact on the validity of the study results.
Key Trial Info
Start Date :
October 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2025
Estimated Enrollment :
260 Patients enrolled
Trial Details
Trial ID
NCT04452175
Start Date
October 30 2021
End Date
February 1 2025
Last Update
May 8 2024
Active Locations (1)
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1
CPCT
Catania, Italy