Electronic Cigarettes in Smokers With Mental Illness

Study Overview
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Brief Summary
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People with mental illness are more likely to smoke and are more severely addicted to nicotine than the general population. As a result, the number of deaths related to tobacco is higher. Smoking is highly addictive because it delivers nicotine very quickly. Research studies show that people who use nicotine replacement therapies (such us patches, gums, etc) are more likely to quit smoking than those who try to quit without using these nicotine products. Recently a new electronic nicotine delivery system (ENDS), also known as electronic cigarette (e-cigarette) is rapidly gaining popularity. Electronic cigarettes are devices that mimic traditional cigarettes and deliver nicotine but do not carry the dangerous chemicals contained in tobacco cigarettes. Given the increasing popularity of e-cigs, there is an urgent need to improve our understanding of both the potential benefits and risks of e-cigs use in people with serious mental illness. In this pilot we propose inviting 50 people with schizophrenia (or schizophrenia-related disorder) who are not intending to quit smoking in the near future to take part in a study in which we will provide 6-weeks of free e-cigs, followed by a 4-week period in which they will not receive free e-cigs and we monitor which products participants choose, and a final 24-week follow-up visit. During the 24-week study period we will assess the use of e-cigs and tobacco cigarettes, the exposure to nicotine and tobacco toxicants, nicotine withdrawal symptoms, the changes in respiratory symptoms and psychiatric symptoms as well as the e-cigs perceived benefits and risks.

Official Title
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Acceptability, Patterns of Use and Safety of Electronic Cigarette in People With Mental Illness: a Pilot Study

Conditions
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Schizophrenia, Schizophreniform Disorder, Bipolar Disorder

Intervention / Treatment
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* Other: disposable electronic cigarettes


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: smokers (≥ 5 cigarettes/day for > 1 yr and breath CO > 5 ppm) ages 18-65 years ICD-10 diagnosis of schizophreniform, schizophrenia, schizoaffective or bipolar disorder Exclusion Criteria: used e-cigs on > 2 occasions in the past 30 days; intend to quit smoking within the next 30 days; currently use medications that may reduce smoking (bupropion, varenicline, NRT, naltrexone, buprenorphine, acamprosate, baclofen, clonidine, nortriptyline, anti-seizure medications, disulfiram); have unstable psychiatric conditions (hospitalization or change in dose of chronic medication in the past 30 days); People with a serious medical condition including uncontrolled high blood pressure, something wrong with their heart or blood vessels that occurred or got worse in the past 3 months (including fast or irregular heart rhythm, angina, chest pain, had a heart attack or stroke). People who have ever had a serious stomach ulcer, and/or phaeochromocytoma (tumor of the adrenal gland). People who in the last 3 months have had severe heartburn; or a stroke, or unstable kidney disease, unstable liver disease, uncontrolled over-active thyroid gland met DSM-IV criteria for drug dependence have medical contraindications to nicotine, since nicotine intake may increase in this study; have past-month suicidal ideation or past-year suicide attempt. are pregnant, as determined through a pregnancy test

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electronic cigarettes<br>Free disposable electronic cigarettes will be provided during 6 weeks to smokers with serious mental illness. | Other: disposable electronic cigarettes<br>* Participants will receive e-cigs free of charge during 6-week. Each week for 6 weeks, participants will receive enough e-cigs to cover 150% of their usual weekly cigarette smoking rate. We will encourage participants to use the e-cigs whenever they would usually smoke a cigarette. During a 4-week post-distribution period, we will assess e-cig and cigarette use and other measures when e-cigs are not being freely provided and participants must purchase them on their own. The Week 10 session at the end of this period includes assessment of total nicotine intake, nicotine dependence, subjective and reinforcing effects of e-cigs and cigarettes, attitudes toward e-cigs, motivation to quit and self-efficacy for smoking cessation. At the Week 24 follow-up session we will again collect these measures to determine if any changes observed during the intervention phases have been maintained.<br>* Other names: NJOY;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Electronic cigarette use | Time Line Follow Back (TLFB) questionnaire | weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks | 
| electronic cigarette acceptability | electronic cigarette evaluation scale (it measures product liking, satisfaction, sensory and physical effects) | Baseline, week 2, week6, week 10 and week 24 | 
| Respiratory symptoms | An abbreviated and adapted version of the American Thoracic Society Questionnaire (ATS) will be used to assess respiratory symptoms. | weekly measures from baseline to 10 weeks and at 24 weeks | 
| Cotinine | Cotinine levels in urine | Baseline, week 2, 6, 10 and 24 | 
| Nitrosamines | NNAL and 3-HPMA levels in urine | Baseline and at 6 week | 
| Side effects of antipsychotics | The Udvalg for Kliniske Undersøgelser (UKU) scale | weekly the first 10 weeks and at 24 weeks | 
| Withdrawal symptoms | Mood and Physical Symptoms Scale, MPSS | weekly the first 10 weeks and at 24 weeks | 
| Respiratory symptoms | Peak Expiratory Flow Rate (PEFR) to monitor airway obstruction, assess its severity and variation. | weekly the first 10 weeks and at 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictors of e-Cigs use | Motivation To Stop Scale -MTSS- | Baseline, week 2, 6, 10 and 24. | 
| Predictors of e-Cigs use | Smoking Consequences Questionnaire | Baseline, week 2, 6, 10 and 24 | 
| Psychiatric symptoms | Positive and Negative Syndrome Scale | weekly during the first 10 weeks and at 24 weeks | 
| Psychiatric symptoms | Calgary Depression Scale for Schizophrenia | weekly the first 10 weeks and at 24 weeks | 
| Physical symptoms | Blood pressure and heart rate | weekly the first 10 weeks and at 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electronic cigarettes, smoking, schizophrenia, serious mental illness