Electronic Cigarettes in Smokers With Mental Illness (APUS e-Cigs)
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|ClinicalTrials.gov Identifier: NCT02212041|
Recruitment Status : Completed
First Posted : August 8, 2014
Last Update Posted : May 16, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizophreniform Disorder Bipolar Disorder||Other: disposable electronic cigarettes||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Acceptability, Patterns of Use and Safety of Electronic Cigarette in People With Mental Illness: a Pilot Study|
|Actual Study Start Date :||September 24, 2014|
|Actual Primary Completion Date :||May 2, 2017|
|Actual Study Completion Date :||May 2, 2017|
Experimental: Electronic cigarettes
Free disposable electronic cigarettes will be provided during 6 weeks to smokers with serious mental illness.
Other: disposable electronic cigarettes
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.
Other Name: NJOY
- Electronic cigarette use [ Time Frame: weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks ]Time Line Follow Back (TLFB) questionnaire
- electronic cigarette acceptability [ Time Frame: Baseline, week 2, week6, week 10 and week 24 ]electronic cigarette evaluation scale (it measures product liking, satisfaction, sensory and physical effects)
- Respiratory symptoms [ Time Frame: weekly measures from baseline to 10 weeks and at 24 weeks ]An abbreviated and adapted version of the American Thoracic Society Questionnaire (ATS) will be used to assess respiratory symptoms.
- Cotinine [ Time Frame: Baseline, week 2, 6, 10 and 24 ]Cotinine levels in urine
- Nitrosamines [ Time Frame: Baseline and at 6 week ]NNAL and 3-HPMA levels in urine
- Side effects of antipsychotics [ Time Frame: weekly the first 10 weeks and at 24 weeks ]The Udvalg for Kliniske Undersøgelser (UKU) scale
- Withdrawal symptoms [ Time Frame: weekly the first 10 weeks and at 24 weeks ]Mood and Physical Symptoms Scale, MPSS
- Respiratory symptoms [ Time Frame: weekly the first 10 weeks and at 24 weeks ]Peak Expiratory Flow Rate (PEFR) to monitor airway obstruction, assess its severity and variation.
- Predictors of e-Cigs use [ Time Frame: Baseline, week 2, 6, 10 and 24. ]Motivation To Stop Scale -MTSS-
- Predictors of e-Cigs use [ Time Frame: Baseline, week 2, 6, 10 and 24 ]Smoking Consequences Questionnaire
- Psychiatric symptoms [ Time Frame: weekly during the first 10 weeks and at 24 weeks ]Positive and Negative Syndrome Scale
- Psychiatric symptoms [ Time Frame: weekly the first 10 weeks and at 24 weeks ]Calgary Depression Scale for Schizophrenia
- Physical symptoms [ Time Frame: weekly the first 10 weeks and at 24 weeks ]Blood pressure and heart rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02212041
|South London and Maudsley Foundation Trust (SLaM)|
|London, United Kingdom, SE5 8AF|
|Principal Investigator:||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|