drugset / Trial / NCT02905734

Nicotine Replacement Therapy in Nicotine-dependent Arrestees

NCT02905734

Phase 4 Completed 800 enrolled Assistance Publique - Hôpitaux de Paris
RandomizedParallel-groupSingle-blindTreatment

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.

Timeline

Start
2017-01-03
Primary completion
2020-11-25
Completion
2021-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Nicotine Unknown 14 mg Other
Subject Nicotine Unknown 21 mg Other

Indications