Nicotine Replacement Therapy in Nicotine-dependent Arrestees

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Primary endpoint: self-assessment of detention course by the arrestee (Likert scale). Secondary endpoints: Desire to smoke during detention in police cells (Likert scale); willingness to change their tobacco use (Likert scale); tobacco use at 1 and 6 months. Methods: The study design includes two parts. The first part will be the intervention (patch administration) during detention in police cells: single blind randomized administration of a nicotine patch or a placebo patch. The second part will be observational and include follow-up evaluations at 7-10 days, 1 month and 6 months. The active treatment will consist of a single administration of nicotine patches (21 mg/24h or 14 mg/24h according to the Heaviness of smoking index [HIS], 21 mg for those with HSI>3, 14 mg for those with HSI of 1 or 2). The control treatment will be a non-active placebo patch. Number of participants: 1000 (two groups of 500). The total duration of the study will be 33 months.

Official Title
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Nicotine Replacement Therapy in Nicotine-dependent Arrestees: a Monocentric Randomized Simple Blind Study

Conditions
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Nicotine Dependence

Intervention / Treatment
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* Drug: Nicotine patch
* Other: placebo patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 76 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: nicotine replacement patch<br>Single administration of a nicotine patch (14 mg or 21 mg, according to the Heaviness of Smoking Index) | Drug: Nicotine patch<br>* Single administration of an active treatment (nicotine patch)<br>* Other names: NICOPATCHLIB;|
| Placebo Comparator: placebo patch<br>Single administration of a placebo patch | Other: placebo patch<br>* Single administration of a placebo treatment<br>* Other names: TEGADERM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perceived quality of detention in police cells at 8 hours following treatment administration | self-assessment of detention course by the arrestee (Likert scale). | 8 hours maximum after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rating of desire to smoke after treatment administration | Desire to smoke during detention in police cells (Likert scale) | 8 hours maximum after treatment | 
| Rating of intention to quit smoking after treatment administration; | willingness to change their tobacco use (Likert scale) | 8 hours maximum after treatment | 
| Mean number of cigarettes per day at one month | tobacco use at 1 month consultation | one month after treatment | 
| Mean number of cigarettes per day at six months | tobacco use at 6 months consultation | six months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nicotine replacement therapy, Tobacco