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 Any female participant who becomes pregnant during this study will be withdrawn.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 programme
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, haematological 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
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