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

NCT04452175 | Recruiting

• 1 other identifier: GENESIS, RCT UKRIT
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking; Schizophrenia Spectrum and Other Psychotic Disorders

Outcome Measures

Primary Outcomes (1)

• Rates of participants with continuous smoking abstinence at 6-month

  self-reported continuous smoking abstinence at 6-month from the previous visit, biochemically verified by exhaled CO measurements of ≤ 7 ppm

  24 WEEK

Secondary Outcomes (8)

• Rates of participants with continuous smoking abstinence at 12-month

  52 WEEK

• Rates of participants with continuous smoking reduction at 6-month

  24 WEEK

• Rates of participants with continuous smoking reduction at 12-month

  52 WEEK

• Proportion of AEs

  24 WEEK

• Absolute change in PANSS

  24 WEEK

Study Arms (2)

HIGH 5%

EXPERIMENTAL

Other: JUUL E-CIGARETTE

LOW 1.7%

ACTIVE COMPARATOR

Other: JUUL E-CIGARETTE

Interventions

JUUL E-CIGARETTE OTHER

JUUL E-CIGARETTE USAGE FOR 24 WEEKS

HIGH 5%; LOW 1.7%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Catania: lead
• Juul Labs, Inc.: collaborator
• St. Petersburg State Pavlov Medical University: collaborator
• Bashkir State Medical University: collaborator
• Ukrainian Institute on Public Health Policy: collaborator
• University of Surrey: collaborator
• Eclat Srl.: collaborator

Study Sites (1)

CPCT

Catania, Italy

RECRUITING

MeSH Terms

Conditions

Smoking; Schizophrenia Spectrum and Other Psychotic Disorders

Condition Hierarchy (Ancestors)

Behavior; Mental Disorders

Study Officials

• Pasquale Caponnetto

  University of Catania

  PRINCIPAL INVESTIGATOR

Central Study Contacts

PASQUALE CAPONNETTO, PhD

CONTACT

00390953781537; p.caponnetto@unict.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 24, 2020
• First Posted: June 30, 2020
• Study Start: October 30, 2021
• Primary Completion: November 1, 2024
• Study Completion: February 1, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Locations

IT (1)