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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
50
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.
South London and Maudsley Foundation Trust (SLaM)
London, United Kingdom
Electronic cigarette use
Time Line Follow Back (TLFB) questionnaire
Time frame: 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)
Time frame: 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.
Time frame: weekly measures from baseline to 10 weeks and at 24 weeks
Cotinine
Cotinine levels in urine
Time frame: Baseline, week 2, 6, 10 and 24
Nitrosamines
NNAL and 3-HPMA levels in urine
Time frame: Baseline and at 6 week
Side effects of antipsychotics
The Udvalg for Kliniske Undersøgelser (UKU) scale
Time frame: weekly the first 10 weeks and at 24 weeks
Withdrawal symptoms
Mood and Physical Symptoms Scale, MPSS
Time frame: 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.
Time frame: weekly the first 10 weeks and at 24 weeks
Predictors of e-Cigs use
Motivation To Stop Scale -MTSS-
Time frame: Baseline, week 2, 6, 10 and 24.
Predictors of e-Cigs use
Smoking Consequences Questionnaire
Time frame: Baseline, week 2, 6, 10 and 24
Psychiatric symptoms
Positive and Negative Syndrome Scale
Time frame: weekly during the first 10 weeks and at 24 weeks
Psychiatric symptoms
Calgary Depression Scale for Schizophrenia
Time frame: weekly the first 10 weeks and at 24 weeks
Physical symptoms
Blood pressure and heart rate
Time frame: weekly the first 10 weeks and at 24 weeks
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