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临床试验/NCT02212041
NCT02212041已完成不适用

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

King's College London2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2014年9月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Electronic cigarette use

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Electronic cigarette use

时间窗: weekly measurements from baseline to 10 weeks and a final assessment at 24 weeks

Time Line Follow Back (TLFB) questionnaire

electronic cigarette acceptability

时间窗: Baseline, week 2, week6, week 10 and week 24

electronic cigarette evaluation scale (it measures product liking, satisfaction, sensory and physical effects)

Respiratory symptoms

时间窗: weekly the first 10 weeks and at 24 weeks

Peak Expiratory Flow Rate (PEFR) to monitor airway obstruction, assess its severity and variation.

Cotinine

时间窗: Baseline, week 2, 6, 10 and 24

Cotinine levels in urine

Nitrosamines

时间窗: Baseline and at 6 week

NNAL and 3-HPMA levels in urine

Side effects of antipsychotics

时间窗: weekly the first 10 weeks and at 24 weeks

The Udvalg for Kliniske Undersøgelser (UKU) scale

Withdrawal symptoms

时间窗: weekly the first 10 weeks and at 24 weeks

Mood and Physical Symptoms Scale, MPSS

次要结局

  • Predictors of e-Cigs use(Baseline, week 2, 6, 10 and 24)
  • Psychiatric symptoms(weekly the first 10 weeks and at 24 weeks)
  • Physical symptoms(weekly the first 10 weeks and at 24 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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