Cigarette Consumption After switchinG to High or Low Nicotine strENght E-cigaretteS In Smokers With Schizophrenia

Launched by UNIVERSITY OF CATANIA · Jun 27, 2020

Keywords

ClinConnect Summary

This clinical trial is exploring whether switching smokers with schizophrenia spectrum disorders to high or low nicotine strength e-cigarettes can help them reduce or quit smoking more effectively. Since people with these conditions often face serious health issues from smoking, the study is looking at how the JUUL e-cigarette, which comes in two nicotine strengths (5% and 1.7%), affects smoking habits. Researchers believe the higher nicotine strength may offer a better chance for these individuals to cut down or quit smoking altogether.

To participate in this trial, you must be an adult over 18 years old, smoke at least 10 cigarettes a day for the past year, and have a diagnosis of a schizophrenia spectrum disorder. It’s important that you are currently not trying to quit smoking. If you join, you will receive either the high or low nicotine e-cigarette and be monitored over time to see how it affects your smoking behavior. This trial is currently recruiting participants, and your involvement could contribute to finding better smoking cessation options for people with similar health challenges.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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 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.
• • 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.