Nicotine Replacement Therapy in Nicotine-dependent Arrestees

• Status: Completed
• Trial end date: 2021-05-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: Nicotine

Criteria

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