Nicotine Replacement Therapy in Nicotine-dependent Arrestees: a Monocentric Randomized Simple Blind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Perceived quality of detention in police cells at 8 hours following treatment administration
研究概览
简要总结
Tobacco use affects more than 50% of adult arrestees, of which 70% are dependent on nicotine. However, they have no access to tobacco during detention in police cells. Nicotine withdrawal symptoms, that include irritability, anxiety and lack of concentration, may worsen the arrestee's health status during detention. Nicotine withdrawal is a treatable condition. Validated treatments in other situations than police custody include nicotine replacement therapy.
This study is based on the following hypotheses: Manifestations related to nicotine withdrawal could increase the discomfort due to detention in police cells, A nicotine replacement therapy initiated during detention could improve the course of detention in police cells and could be useful in a perspective of long-lasting smoking cessation.
The primary objective is to evaluate the efficacy of nicotine replacement therapy among nicotine-dependent arrestees on the course of detention as perceived by the arrestees. Our secondary objectives are to evaluate the efficacy of nicotine replacement therapy on desire to smoke during detention in police cells and to improve long-term smoking cessation among dependent smokers.
Interventions consist in the single administration of an active treatment (nicotine patch) or of a control treatment (placebo patch). Evaluations will include the results of a medical examination during detention, a self evaluation by the arrestees of their desire to smoke, and medical consultations and evaluations of tobacco use 7-10 days, one month and six months later.
详细描述
Police custody is a matter of significant public attention in France, as approximately 700,000 people are detained in police cells each year in this country.
Tobacco use affects more than 50% of adult arrestees, of which 70% are dependent on nicotine. However, they have no access to tobacco during detention in police cells. Nicotine withdrawal symptoms, including irritability, anxiety and lack of concentration, may worsen the arrestee's health status during detention. Nicotine withdrawal is a treatable condition. Validated treatments in other situations than police custody include nicotine replacement therapy. Available medical guidelines in police custody do not mention nicotine dependence.
This study is based on the following hypotheses: (1) Manifestations related to nicotine withdrawal could increase discomfort due to the detention in police cells, (2) A nicotine replacement therapy initiated during detention could improve the course of detention in police cells and (3) could be useful in a perspective of long-lasting smoking cessation.
The primary objective is to evaluate the efficacy of nicotine replacement therapy among nicotine-dependent arrestees on the course of detention as perceived by the arrestees. The secondary objectives are to evaluate the efficacy of nicotine replacement therapy on desire to smoke during detention in police cells and to improve long-term smoking cessation among dependent smokers.
Interventions consist in the single administration of an active treatment (nicotine patch) or of a control treatment (placebo patch). Evaluations will include the results of a medical examination during detention, a self-assessment by the arrestees of their desire to smoke, and medical consultations and evaluations of tobacco use 7-10 days, one month and six months later.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Arrestees examined by a physician during detention in police cells
- •aged 18 or older
- •smoking at least 10 cigarettes per day
- •giving written consent to participate in the study
- •health status compatible with detention in police cells
排除标准
- •Lack of understanding of the study
- •contra-indication to nicotine replacement therapy
- •health status incompatible with detention in police cells
- •serious mental disorder
- •usual place of residence outside Seine-Saint-Denis
研究组 & 干预措施
nicotine replacement patch
Single administration of a nicotine patch (14 mg or 21 mg, according to the Heaviness of Smoking Index)
干预措施: Nicotine patch (Drug)
placebo patch
Single administration of a placebo patch
干预措施: placebo patch (Other)
结局指标
主要结局
Perceived quality of detention in police cells at 8 hours following treatment administration
时间窗: 8 hours maximum after treatment
self-assessment of detention course by the arrestee (Likert scale).
次要结局
- Rating of desire to smoke after treatment administration(8 hours maximum after treatment)
- Rating of intention to quit smoking after treatment administration;(8 hours maximum after treatment)
- Mean number of cigarettes per day at one month(one month after treatment)
- Mean number of cigarettes per day at six months(six months after treatment)