Nicotine Replacement Therapy in Nicotine-dependent Arrestees

NCT02905734 | Completed Phase 4 DMC

• 1 other identifier: P 140703
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nicotine Dependence

Keywords

Nicotine replacement therapy; Tobacco

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Rating of desire to smoke after treatment administration

  8 hours maximum after treatment

• Rating of intention to quit smoking after treatment administration;

  8 hours maximum after treatment

• Mean number of cigarettes per day at one month

  one month after treatment

• Mean number of cigarettes per day at six months

  six months after treatment

Study Arms (2)

nicotine replacement patch

EXPERIMENTAL

Single administration of a nicotine patch (14 mg or 21 mg, according to the Heaviness of Smoking Index)

Drug: Nicotine patch

placebo patch

PLACEBO COMPARATOR

Single administration of a placebo patch

Other: placebo patch

Interventions

Nicotine patch DRUG

Single administration of an active treatment (nicotine patch)

Also known as: NICOPATCH, NICOPATCHLIB

nicotine replacement patch

placebo patch OTHER

Single administration of a placebo treatment

Also known as: duoderm spot, TEGADERM

placebo patch

Eligibility Criteria

• Age: 18 Years - 76 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Médecine légale - Hôpital Jean Verdier

Bondy, 93143, France

Location

Related Publications (5)

• 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.

  PMID: 24210771 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.

  PMID: 24671410 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.

  PMID: 19996145 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.

  PMID: 23228222 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.

  PMID: 23911847 BACKGROUND

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Patrick CHARIOT, MD

  Hospital Jean Verdier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 19, 2016
• Study Start: January 3, 2017
• Primary Completion: November 25, 2020
• Study Completion: May 30, 2021
• Last Updated: June 28, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)