Switching to high or low nicotine e-cigarettes for 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

This study is testing whether using high or low nicotine e-cigarettes can help adults with schizophrenia cut down on smoking.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 260 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Catania (other)
• Locations: 1 site (Catania)
• Trial ID: NCT04452175 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of high versus low nicotine strength e-cigarettes in reducing smoking among adults with schizophrenia spectrum disorders. It employs a randomized, double-blind, two-arm parallel design across five international sites, comparing the use of JUUL e-cigarettes with 5% nicotine to those with 1.7% nicotine over a 12-month period. Participants will be monitored for changes in smoking behavior, tolerability, and symptom severity related to their mental health condition. The study aims to provide insights into alternative smoking cessation methods for this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates are adults over 18 who smoke more than 10 cigarettes a day and have a diagnosis of a schizophrenia spectrum disorder.

Not a fit: Patients who are currently attempting to quit smoking or have recently experienced acute decompensation of their schizophrenia symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could offer a safer alternative to traditional smoking methods, potentially reducing smoking-related health risks for patients with schizophrenia.

How similar studies have performed: Emerging research suggests that e-cigarettes may be effective for smoking cessation in individuals with schizophrenia, indicating potential success for this approach.

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.

Where this trial is running

Catania

• CPCT — Catania, Italy (RECRUITING)

Study contacts

• Principal investigator: Pasquale Caponnetto — University of Catania
• Study coordinator: PASQUALE CAPONNETTO, PhD

Conditions: Smoking, Schizophrenia Spectrum and Other Psychotic Disorders