RecruitingNot ApplicableNCT04452175

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

Cigarette Consumption After switchinG to High or Low Nicotine strENght E-cigaretteS In Smokers With Schizophrenia Spectrum Disorders: A 12-month Randomised, Double-blind Multicentre Trial


Sponsor

University of Catania

Enrollment

260 participants

Start Date

Oct 30, 2021

Study Type

INTERVENTIONAL

Conditions

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 this vulnerable group are unsatisfactory. Considering that most people with schizophrenia spectrum disorders continue smoking, it is urgent to consider alternative and more efficient interventions to reduce or prevent their morbidity and mortality. Switching to combustion-free technologies for nicotine delivery (I.e. e-cigarettes) could be a pragmatic and much less harmful alternative to tobacco smoking with the possibility of significant health gains. Emerging research is suggesting that ECs may be useful for smoking cessation and relapse prevention in people with schizophrenia spectrum disorders. In particular, a study conducted with JUUL e-cigarette with 5% nicotine strength showed that this product had sufficient nicotine delivery and product appeal to determine high success rates in heavy smokers with schizophrenia spectrum disorders. In consideration of these preliminary findings, we hypothesized that switching smokers with a schizophrenia spectrum disorder diagnosis to JUUL e-cigarette with 5% nicotine strength could result in higher success rates compared to JUUL e-cigarette with 1.7% nicotine strength. Recent work indicates that nicotine PK of the JUUL e-cigarette with 5% nicotine strength (a device that utilizes a nicotine salt formulation) approximates the nicotine delivery of combustible cigarettes and that the 5% nicotine strength product is far more efficient in delivering nicotine compared to the sister product with 1.7% nicotine strength. Both products are identical in their appearance, making them suitable for a double-blind study design.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether switching to e-cigarettes with different nicotine levels can reduce how many cigarettes people with schizophrenia or related conditions smoke each day. Researchers want to understand if vaping could be a harm-reduction tool for heavy smokers with these mental health conditions. **You may be eligible if:** - You are over 18 and smoke more than 10 cigarettes a day (for at least one year) - You have been diagnosed with schizophrenia, schizoaffective disorder, or a related condition - You are not trying to quit smoking in the next 30 days - You are not currently living in an institution **You may NOT be eligible if:** - Your schizophrenia symptoms have worsened significantly in the last month - Your antipsychotic medication was changed in the last month - You have had a heart attack, angina, or serious health hospitalization in the last 3 months - You have poorly controlled asthma or COPD - You are pregnant, planning to become pregnant, or breastfeeding - You regularly use other nicotine or tobacco products (vapes, heated tobacco) - You have used stop-smoking medications in the last 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERJUUL E-CIGARETTE

JUUL E-CIGARETTE USAGE FOR 24 WEEKS


Locations(1)

CPCT

Catania, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04452175


Related Trials