Actively Recruiting
Cigarette Consumption After switchinG to High or Low Nicotine strENght E-cigaretteS In Smokers With Schizophrenia
Led by University of Catania · Updated on 2024-05-08
260
Participants Needed
1
Research Sites
170 weeks
Total Duration
On this page
Sponsors
U
University of Catania
Lead Sponsor
J
Juul Labs, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Cigarette Consumption After switchinG to High or Low Nicotine strENght E-cigaretteS In Smokers With Schizophrenia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult (over 18 years old)
- Regular smoker of more than 10 cigarettes a day for at least one year
- Exhaled breath carbon monoxide (eCO) level greater than 7 ppm
- Not currently trying to quit smoking and no intention to quit in the next 30 days
- Diagnosed with schizophrenia spectrum disorder by DSM-V criteria
- Able to understand and provide informed consent
- Able to follow all study procedures
You will not qualify if you...
- Institutionalized patients
- Acute worsening of schizophrenia symptoms in the past month
- Change in antipsychotic medication within the past month
- Hospitalization for serious medical condition within 3 months before screening
- Heart attack or angina within 3 months before screening
- Poorly controlled asthma or COPD
- Pregnant, planning pregnancy, or breastfeeding
- Significant history of alcoholism or drug abuse within 12 months before screening
- Willing to join a smoking cessation program
- Regular use of other recreational nicotine or tobacco products within 30 days before screening
- Use of smoking cessation therapies within 30 days before screening
- Currently or recently participating in another clinical study involving investigational drugs
- History of major medical or psychiatric disorders that may affect safety or study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
CPCT
Catania, Italy
Actively Recruiting
Research Team
P
PASQUALE CAPONNETTO, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here