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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nicotine replacement patch | Experimental | Single administration of a nicotine patch (14 mg or 21 mg, according to the Heaviness of Smoking Index) |
|
| placebo patch | Placebo Comparator | Single administration of a placebo patch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine patch | Drug | Single administration of an active treatment (nicotine patch) |
|
| 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 |
| 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; |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Patrick CHARIOT, MD | Hospital Jean Verdier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Médecine légale - Hôpital Jean Verdier | Bondy | 93143 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24210771 | Background | Chariot P, Lepresle A, Lefevre T, Boraud C, Barthes A, Tedlaouti M. Alcohol and substance screening and brief intervention for detainees kept in police custody. A feasibility study. Drug Alcohol Depend. 2014 Jan 1;134:235-241. doi: 10.1016/j.drugalcdep.2013.10.006. Epub 2013 Oct 23. | |
| 24671410 | Background | Chariot P, Beaufrere A, Denis C, Dang C, Vincent R, Boraud C. Detainees in police custody in the Paris, France area: medical data and high-risk situations (a prospective study over 1 year). Int J Legal Med. 2014 Sep;128(5):853-60. doi: 10.1007/s00414-014-0990-4. Epub 2014 Mar 27. |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| placebo patch | Other | Single administration of a placebo treatment |
|
|
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 |
| 19996145 | Background | Cropsey KL, Jones-Whaley S, Jackson DO, Hale GJ. Smoking characteristics of community corrections clients. Nicotine Tob Res. 2010 Jan;12(1):53-8. doi: 10.1093/ntr/ntp172. Epub 2009 Dec 8. |
| 23228222 | Background | Richmond R, Indig D, Butler T, Wilhelm K, Archer V, Wodak A. A randomized controlled trial of a smoking cessation intervention conducted among prisoners. Addiction. 2013 May;108(5):966-74. doi: 10.1111/add.12084. Epub 2013 Mar 11. |
| 23911847 | Background | Tzelepis F, Paul CL, Walsh RA, Knight J, Wiggers J. Who enrolled in a randomized controlled trial of quitline support? Comparison of participants versus nonparticipants. Nicotine Tob Res. 2013 Dec;15(12):2107-13. doi: 10.1093/ntr/ntt114. Epub 2013 Aug 3. |