Nicotine Replacement Therapy in Nicotine-dependent Arrestees (SUBNIGAV)

June 25, 2021 updated by: Assistance Publique - Hôpitaux de Paris

Nicotine Replacement Therapy in Nicotine-dependent Arrestees: a Monocentric Randomized Simple Blind Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

800

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bondy, France, 93143
        • Médecine légale - Hôpital Jean Verdier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 76 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: nicotine replacement patch
Single administration of a nicotine patch (14 mg or 21 mg, according to the Heaviness of Smoking Index)
Drug: Nicotine patch
Single administration of an active treatment (nicotine patch)
Other Names:
  • NICOPATCH
  • NICOPATCHLIB
Placebo Comparator: placebo patch
Single administration of a placebo patch
Other: placebo patch
Single administration of a placebo treatment
Other Names:
  • duoderm spot
  • TEGADERM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived quality of detention in police cells at 8 hours following treatment administration
Time Frame: 8 hours maximum after treatment
self-assessment of detention course by the arrestee (Likert scale).
8 hours maximum after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rating of desire to smoke after treatment administration
Time Frame: 8 hours maximum after treatment
Desire to smoke during detention in police cells (Likert scale)
8 hours maximum after treatment
Rating of intention to quit smoking after treatment administration;
Time Frame: 8 hours maximum after treatment
willingness to change their tobacco use (Likert scale)
8 hours maximum after treatment
Mean number of cigarettes per day at one month
Time Frame: one month after treatment
tobacco use at 1 month consultation
one month after treatment
Mean number of cigarettes per day at six months
Time Frame: six months after treatment
tobacco use at 6 months consultation
six months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Investigators

  • Principal Investigator: Patrick CHARIOT, MD, Hospital Jean Verdier

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 3, 2017

Primary Completion (Actual)

November 25, 2020

Study Completion (Actual)

May 30, 2021

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 14, 2016

First Posted (Estimate)

September 19, 2016

Study Record Updates

Last Update Posted (Actual)

June 28, 2021

Last Update Submitted That Met QC Criteria

June 25, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P 140703

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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