SmokingGENESISNCT04452175
Cigarette Consumption After switchinG to High or Low Nicotine strENght E-cigaretteS In Smokers With Schizophrenia
A study testing JUUL E-CIGARETTE in people with Smoking and Schizophrenia Spectrum and Other Psychotic Disorders, run by University of Catania at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking, Schizophrenia Spectrum and Other Psychotic Disorders
- What is being tested?
- JUUL E-CIGARETTE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteItaly
- Study dates
- 30 Oct 2021to Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
Multicenter, 12-months prospective trial, utilizing a randomized, double-blind, 2-arm parallel, switching design to compare effectiveness, tolerability, acceptability, and pattern of use between high (JUUL 5% nicotine) and low nicotine strength devices (JUUL 1.7% nicotine) in adult smokers with schizophrenia spectrum disorders. The study will take place at 5 international sites: UK (London), Italy (Catania), Russia (Ufa and St. Petersburg) and Ukraine (Kiev).
The two devices have identical appearance and will be assigned in a double-blind fashion. Study products will be provided for a total of 6-months (intervention phase); the intervention phase will be followed by a further 6-months observational period (follow-up phase) during which no products will be dispensed to participants. Throughout the follow-up phase and up to the final visit at 12-months, changes in smoking/vaping behavior and in their pattern of use will be tracked under naturalistic condition and compared between study groups. Any changes in symptom severity related to schizophrenia spectrum disorders within and between both arms of the study will be monitored. The intervention phase of the study will consist of a total of nine visits (including screening). The follow-up phase will consist of three additional visits (two telephone contacts and one final face to face visit).
In summary, the main objectives of the study will be to:
- Quantify the proportion of continuous quitters among participants at 6-months in both arms of the study;
- Quantify the proportion of continuous reducers among participants at 6-months in both arms of the study;
- Quantify the proportion of continuous quitters among participants at 12-months in both arms of the study;
- Quantify the proportion of continuous reducers among participants at 12-months in both arms of the study;
- Compare continuous quit and reduction rates between study arms at 6- and 12-months;
- Quantify adverse events throughout the whole duration of the interventional phase of the study in both arms;
- Compare adverse events between study arms.
Additional objectives of the study will be to:
- Measure Subjective perceptions and experiences of the two nicotine strenghts by the psychometrically validated modified Cigarette Evaluation Questionnaire - mCEQ (at 6-months);
- Compare level of mCEQ between study arms (at 6-months);
- Assess pattern of products use among participants throughout the whole duration of the study (both at intervention + follow-up phases) in both arms of the study;
- Compare pattern of product use between study arms (both at intervention + follow-up phases).
- Compare changes in symptom severity of patients with schizophrenia by Positive and Negative Syndrome Scale (PANSS) within and between both arms of the study (both at 6- and 12-months);
- Compare changes in exercise tolerance by Chester Step Test within and between both arms of the study (only at 6-months);
- Compare changes in weight/BMI within and between both arms of the study (both at 6- and 12-months);
- Quantify self-rated mental health (SRMH) throughout the whole duration of the study (by means of a specifically designed APP) within and between both arms of the study (both at 6- and 12-months).
- Being tested
- JUUL E-CIGARETTE
- Medical subject headings
- Smoking, Schizophrenia Spectrum and Other Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JUUL E-CIGARETTEOther
JUUL E-CIGARETTE USAGE FOR 24 WEEKS
| Study group | Role | What they receive |
|---|---|---|
| HIGH 5% | Experimental | Not described Receives: Other: JUUL E-CIGARETTE |
| LOW 1.7% | Active comparator | Not described Receives: Other: JUUL E-CIGARETTE |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24 WEEK
Secondary outcomes (8)
Rates of participants with continuous smoking abstinence at 12-month
Measured: 52 WEEK
Rates of participants with continuous smoking reduction at 6-month
Measured: 24 WEEK
Rates of participants with continuous smoking reduction at 12-month
Measured: 52 WEEK
Proportion of AEs
Measured: 24 WEEK
Absolute change in PANSS
Measured: 24 WEEK
Absolute change in mCEQ
Measured: 24 WEEK
Absolute change in Chester Step Test-derived values
Measured: 24 WEEK
Change in App-derived endpoints (self-rated mental health -SRMH).
Measured: 24 WEEK
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start30 Oct 2021
- Primary completionNov 2024 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catania
- Sponsor type
- University, hospital or other
- Collaborators
- Juul Labs, Inc., St. Petersburg State Pavlov Medical University, Bashkir State Medical University, Ukrainian Institute on Public Health Policy, University of Surrey, Eclat Srl.
- Responsible party
- Principal investigator, PASQUALE CAPONNETTO, University of Catania
- Investigators
- Pasquale Caponnetto, Principal investigator, University of Catania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04452175
- Sponsor's protocol ID
- GENESIS, RCT UKRIT
- Acronym
- GENESIS
- Status last verified
- May 2024
- First submitted
- 24 Jun 2020
- Last updated
- 8 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04452175
- Acronym / sponsor ID
- GENESIS / GENESIS, RCT UKRIT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- University of CataniaUniversity, hospital or other
- Collaborators
- Juul Labs, Inc., St. Petersburg State Pavlov Medical University, Bashkir State Medical University, Ukrainian Institute on Public Health Policy, University of Surrey, Eclat Srl.
- Study start
- 30 Oct 2021 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 30 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Multicenter, 12-months prospective trial, utilizing a randomized, double-blind, 2-arm parallel, switching design to compare effectiveness, tolerability, acceptability, and pattern of use between high (JUUL 5% nicotine) and low nicotine strength devices (JUUL 1.7% nicotine) in adult smokers with schizophrenia spectrum disorders. The study will take place at 5 international sites: UK (London), Italy (Catania), Russia (Ufa and St. Petersburg) and Ukraine (Kiev).
The two devices have identical appearance and will be assigned in a double-blind fashion. Study products will be provided for a total of 6-months (intervention phase); the intervention phase will be followed by a further 6-months observational period (follow-up phase) during which no products will be dispensed to participants. Throughout the follow-up phase and up to the final visit at 12-months, changes in smoking/vaping behavior and in their pattern of use will be tracked under naturalistic condition and compared between study groups. Any changes in symptom severity related to schizophrenia spectrum disorders within and between both arms of the study will be monitored. The intervention phase of the study will consist of a total of nine visits (including screening). The follow-up phase will consist of three additional visits (two telephone contacts and one final face to face visit).
In summary, the main objectives of the study will be to:
- Quantify the proportion of continuous quitters among participants at 6-months in both arms of the study;
- Quantify the proportion of continuous reducers among participants at 6-months in both arms of the study;
- Quantify the proportion of continuous quitters among participants at 12-months in both arms of the study;
- Quantify the proportion of continuous reducers among participants at 12-months in both arms of the study;
- Compare continuous quit and reduction rates between study arms at 6- and 12-months;
- Quantify adverse events throughout the whole duration of the interventional phase of the study in both arms;
- Compare adverse events between study arms.
Additional objectives of the study will be to:
- Measure Subjective perceptions and experiences of the two nicotine strenghts by the psychometrically validated modified Cigarette Evaluation Questionnaire - mCEQ (at 6-months);
- Compare level of mCEQ between study arms (at 6-months);
- Assess pattern of products use among participants throughout the whole duration of the study (both at intervention + follow-up phases) in both arms of the study;
- Compare pattern of product use between study arms (both at intervention + follow-up phases).
- Compare changes in symptom severity of patients with schizophrenia by Positive and Negative Syndrome Scale (PANSS) within and between both arms of the study (both at 6- and 12-months);
- Compare changes in exercise tolerance by Chester Step Test within and between both arms of the study (only at 6-months);
- Compare changes in weight/BMI within and between both arms of the study (both at 6- and 12-months);
- Quantify self-rated mental health (SRMH) throughout the whole duration of the study (by means of a specifically designed APP) within and between both arms of the study (both at 6- and 12-months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HIGH 5% | Experimental | Other: JUUL E-CIGARETTE |
| LOW 1.7% | Active comparator | Other: JUUL E-CIGARETTE |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JUUL E-CIGARETTEJUUL E-CIGARETTE USAGE FOR 24 WEEKS | Other | HIGH 5%, LOW 1.7% |
Primary outcome
Rates of participants with continuous smoking abstinence at 6-month
Time frame: 24 WEEK
self-reported continuous smoking abstinence at 6-month from the previous visit, biochemically verified by exhaled CO measurements of ≤ 7 ppm
8 secondary outcomes
Rates of participants with continuous smoking abstinence at 12-month
Time frame: 52 WEEK
Rates of participants with continuous smoking reduction at 6-month
Time frame: 24 WEEK
Rates of participants with continuous smoking reduction at 12-month
Time frame: 52 WEEK
Proportion of AEs
Time frame: 24 WEEK
Absolute change in PANSS
Time frame: 24 WEEK
Absolute change in mCEQ
Time frame: 24 WEEK
Absolute change in Chester Step Test-derived values
Time frame: 24 WEEK
Change in App-derived endpoints (self-rated mental health -SRMH).
Time frame: 24 WEEK
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pasquale Caponnetto principal investigator
University of Catania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing JUUL E-CIGARETTE in people with Smoking and Schizophrenia Spectrum and Other Psychotic Disorders, run by University of Catania at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact PASQUALE CAPONNETTO, PhD (00390953781537, p.caponnetto@unict.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rates of participants with continuous smoking abstinence at 6-month (time frame: 24 WEEK). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.