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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Electronic cigarettes | Experimental | Free disposable electronic cigarettes will be provided during 6 weeks to smokers with serious mental illness. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| disposable electronic cigarettes | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rocio Perez-Iglesias, MD, PhD | King's College London | Principal Investigator |
| Ann McNeill, BSc, PhD, Prof | King's College London | Principal Investigator |
| Lynne Dawkins, BSc, PhD | University of East London | Principal Investigator |
| John Moxham, MD, PhD, Prof | King's College London | Principal Investigator |
| Philip McGuire, MD, PhD, Prof | King's College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| South London and Maudsley Foundation Trust (SLaM) | London | SE5 8AF | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29986786 | Derived | Hickling LM, Perez-Iglesias R, McNeill A, Dawkins L, Moxham J, Ruffell T, Sendt KV, McGuire P. A pre-post pilot study of electronic cigarettes to reduce smoking in people with severe mental illness. Psychol Med. 2019 Apr;49(6):1033-1040. doi: 10.1017/S0033291718001782. Epub 2018 Jul 10. |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| D001714 | Bipolar Disorder |
| D000072137 | Vaping |
| D012907 | Smoking |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
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Peak Expiratory Flow Rate (PEFR) to monitor airway obstruction, assess its severity and variation.
| weekly the first 10 weeks and at 24 weeks |
| 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 |
| D001519 | Behavior |