Nicotine DependencePhase 4SUBNIGAVNCT02905734
Nicotine Replacement Therapy in Nicotine-dependent Arrestees
A Phase 4 study testing Nicotine patch in people with Nicotine Dependence, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 76 years
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- Nicotine patch
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2017to 30 May 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 76 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Nicotine Dependence
- Being tested
- Nicotine patch, placebo patch
- Keywords
- Nicotine replacement therapy, Tobacco
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotine patchDrug
Also called NICOPATCH, NICOPATCHLIB
Single administration of an active treatment (nicotine patch)
placebo patchOther
Also called duoderm spot, TEGADERM
Single administration of a placebo treatment
| Study group | Role | What they receive |
|---|---|---|
| nicotine replacement patch | Experimental | Single administration of a nicotine patch (14 mg or 21 mg, according to the Heaviness of Smoking Index) Receives: Drug: Nicotine patch |
| placebo patch | Placebo comparator | Single administration of a placebo patch Receives: Other: placebo patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived quality of detention in police cells at 8 hours following treatment administration
self-assessment of detention course by the arrestee (Likert scale).
Measured: 8 hours maximum after treatment
Secondary outcomes (4)
Rating of desire to smoke after treatment administration
Desire to smoke during detention in police cells (Likert scale)
Measured: 8 hours maximum after treatment
Rating of intention to quit smoking after treatment administration;
willingness to change their tobacco use (Likert scale)
Measured: 8 hours maximum after treatment
Mean number of cigarettes per day at one month
tobacco use at 1 month consultation
Measured: one month after treatment
Mean number of cigarettes per day at six months
tobacco use at 6 months consultation
Measured: six months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2016 (estimated)
- Study start3 Jan 2017
- Primary completion25 Nov 2020
- Study completion30 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick CHARIOT, MD, Principal investigator, Hospital Jean Verdier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02905734
- Sponsor's protocol ID
- P 140703
- Acronym
- SUBNIGAV
- Status last verified
- Jun 2021
- First submitted
- 14 Sep 2016
- Last updated
- 28 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24210771Chariot 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.
PubMed 24671410Cropsey 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.
PubMed 19996145Richmond 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.
PubMed 23228222Tzelepis 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.
PubMed 23911847
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Replacement Therapy in Nicotine-dependent Arrestees: a Monocentric Randomized Simple Blind Study
- ClinicalTrials.gov ID
- NCT02905734
- Acronym / sponsor ID
- SUBNIGAV / P 140703
- Conditions
- Nicotine Dependence
- Keywords
- Nicotine replacement therapy, Tobacco
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 30 May 2021 (actual)
- First posted
- 19 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nicotine replacement patch | Experimental | Drug: Nicotine patchSingle administration of a nicotine patch (14 mg or 21 mg, according to the Heaviness of Smoking Index) |
| placebo patch | Placebo comparator | Other: placebo patchSingle administration of a placebo patch |
Who may qualify
- Ages
- 18 to 76 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nicotine patchAlso: NICOPATCH, NICOPATCHLIBSingle administration of an active treatment (nicotine patch) | Drug | nicotine replacement patch |
| placebo patchAlso: duoderm spot, TEGADERMSingle administration of a placebo treatment | Other | placebo patch |
Primary outcome
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).
4 secondary outcomes
Rating of desire to smoke after treatment administration
Time frame: 8 hours maximum after treatment
Rating of intention to quit smoking after treatment administration;
Time frame: 8 hours maximum after treatment
Mean number of cigarettes per day at one month
Time frame: one month after treatment
Mean number of cigarettes per day at six months
Time frame: six months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2021.
- Background: PubMed 24210771Chariot 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.
- Background: PubMed 24671410Chariot 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.
- Background: PubMed 19996145Cropsey 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.
- Background: PubMed 23228222Richmond 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.
- Background: PubMed 23911847Tzelepis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick CHARIOT, MD principal investigator
Hospital Jean Verdier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotine patch in people with Nicotine Dependence, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived quality of detention in police cells at 8 hours following treatment administration (time frame: 8 hours maximum after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02905734, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2021.