Nicotine Replacement Therapy in Nicotine-dependent Arrestees
Condition: Nicotine Dependence
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      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: 
      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.
    

Intervention name(s): Nicotine patch; placebo patch
Intervention type(s): Drug; Other
Intervention description(s): Single administration of an active treatment (nicotine patch); Single administration of a placebo treatment
Other intervention name(s): NICOPATCH; NICOPATCHLIB; duoderm spot; TEGADERM
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Nicotine replacement therapy; Tobacco