Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2026-02-27 @ 2:37 PM
Study NCT ID:
NCT02905734
Status:
COMPLETED
Last Update Posted:
2021-06-28
First Post:
2016-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nicotine Replacement Therapy in Nicotine-dependent Arrestees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014029', 'term': 'Tobacco Use Disorder'}], 'ancestors': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061485', 'term': 'Tobacco Use Cessation Devices'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 800}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2021-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-25', 'studyFirstSubmitDate': '2016-09-14', 'studyFirstSubmitQcDate': '2016-09-14', 'lastUpdatePostDateStruct': {'date': '2021-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived quality of detention in police cells at 8 hours following treatment administration', 'timeFrame': '8 hours maximum after treatment', 'description': 'self-assessment of detention course by the arrestee (Likert scale).'}], 'secondaryOutcomes': [{'measure': 'Rating of desire to smoke after treatment administration', 'timeFrame': '8 hours maximum after treatment', 'description': 'Desire to smoke during detention in police cells (Likert scale)'}, {'measure': 'Rating of intention to quit smoking after treatment administration;', 'timeFrame': '8 hours maximum after treatment', 'description': 'willingness to change their tobacco use (Likert scale)'}, {'measure': 'Mean number of cigarettes per day at one month', 'timeFrame': 'one month after treatment', 'description': 'tobacco use at 1 month consultation'}, {'measure': 'Mean number of cigarettes per day at six months', 'timeFrame': 'six months after treatment', 'description': 'tobacco use at 6 months consultation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Nicotine replacement therapy', 'Tobacco'], 'conditions': ['Nicotine Dependence']}, 'referencesModule': {'references': [{'pmid': '24210771', 'type': 'BACKGROUND', 'citation': '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': '24671410', 'type': 'BACKGROUND', 'citation': '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': '19996145', 'type': 'BACKGROUND', 'citation': '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': '23228222', 'type': 'BACKGROUND', 'citation': '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': '23911847', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nThis 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.\n\nThe 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.\n\nInterventions 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.", 'detailedDescription': "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.\n\nTobacco 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.\n\nThis 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.\n\nThe 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.\n\nInterventions 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.\n\nPrimary endpoint: self-assessment of detention course by the arrestee (Likert scale).\n\nSecondary 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.\n\nMethods:\n\nThe 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.\n\nThe 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.\n\nNumber of participants: 1000 (two groups of 500). The total duration of the study will be 33 months."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '76 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Arrestees examined by a physician during detention in police cells\n* aged 18 or older\n* smoking at least 10 cigarettes per day\n* giving written consent to participate in the study\n* health status compatible with detention in police cells\n\nExclusion Criteria:\n\n* Lack of understanding of the study\n* contra-indication to nicotine replacement therapy\n* health status incompatible with detention in police cells\n* serious mental disorder\n* usual place of residence outside Seine-Saint-Denis'}, 'identificationModule': {'nctId': 'NCT02905734', 'acronym': 'SUBNIGAV', 'briefTitle': 'Nicotine Replacement Therapy in Nicotine-dependent Arrestees', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Nicotine Replacement Therapy in Nicotine-dependent Arrestees: a Monocentric Randomized Simple Blind Study', 'orgStudyIdInfo': {'id': 'P 140703'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'nicotine replacement patch', 'description': 'Single administration of a nicotine patch (14 mg or 21 mg, according to the Heaviness of Smoking Index)', 'interventionNames': ['Drug: Nicotine patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo patch', 'description': 'Single administration of a placebo patch', 'interventionNames': ['Other: placebo patch']}], 'interventions': [{'name': 'Nicotine patch', 'type': 'DRUG', 'otherNames': ['NICOPATCH', 'NICOPATCHLIB'], 'description': 'Single administration of an active treatment (nicotine patch)', 'armGroupLabels': ['nicotine replacement patch']}, {'name': 'placebo patch', 'type': 'OTHER', 'otherNames': ['duoderm spot', 'TEGADERM'], 'description': 'Single administration of a placebo treatment', 'armGroupLabels': ['placebo patch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93143', 'city': 'Bondy', 'country': 'France', 'facility': 'Médecine légale - Hôpital Jean Verdier', 'geoPoint': {'lat': 48.9018, 'lon': 2.48931}}], 'overallOfficials': [{'name': 'Patrick CHARIOT, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Jean Verdier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}