ADDICTAO: Psychological and Addictive Profile of Patients With Buerger's Disease
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Purpose
Background: Buerger's disease (thromboangiitis obliterans or TAO) is a rare disease (1/ 10 000) characterized by the development of segmental thrombotic occlusions of the medium and small arteries of the extremities. Afflicted patients are mostly young, male, inveterate tobacco (or cannabis) smokers who present with distal extremity ischemia, ischemic ulcers, of the toes or fingers. Large arteries are typically spared, as are the coronary, cerebral, and visceral circulations. Patients with TAO often suffer from severe ischemic pain and tissue loss culminating in minor and major limb amputation. Clinical diagnostic criteria generally include history of tobacco abuse; age of onset less than 50 years; infrapopliteal, segmental arterial occlusions with sparing of the proximal vasculature; frequent distal upper extremity arterial involvement (Raynaud's syndrome or digital ulceration); superficial phlebitis; and exclusion of arteriosclerosis, diabetes, true arteritis, proximal embolic source, and hypercoagulable states.
While the cause of Buerger's disease remains unknown, the disease onset and clinical course are inextricably linked to tobacco (or cannabis) abuse. Tobacco abstinence generally results in disease quiescence and remains the mainstay of treatment. For some unknown reason, clinicians observed that TAO patients rarely discontinue smoking even though amputation is usually the inevitable consequence and the only method available of controlling pain and ulceration. Few studies were realized and Hofer-Mayer and coll. found remarkable personality features comparing to coronary patients: TAO patients significantly changed their place of work more often, had more absenteeism from work, smoked more before the illness and continued to smoke more frequently during their illness, were more often single or divorced and had more conflicts in their relationships. Those facts led us to explore their psychopathology and their addictive profile.
Purpose: Search the prevalence of personality disorders in Buerger's patients who present with tobacco or cannabis smoking.
Hypothesis: Patients with Buerger's disease show remarkable personality features (psychological and addictive profile) which are vulnerability factors to stop smoking (tobacco or cannabis) compared to patients with atheromatous arteritis.
| Condition |
|---|
|
Thromboangiitis Obliterans Atheromatous Arteritis |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Study of Psychological and Addictive Profile of Patients With Buerger's Disease |
- SCID personality disorders [ Time Frame: 2013 ] [ Designated as safety issue: No ]
- psychiatric disorders by MINI DSM-IV results [ Time Frame: 2013 ] [ Designated as safety issue: No ]
- RAP Fagerström and Cannabis questionnaire total scores [ Time Frame: 2013 ] [ Designated as safety issue: No ]
- Results of neuropsychological assessment [ Time Frame: 2013 ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
urine
| Estimated Enrollment: | 400 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Buerger's disease patients
200 thromboangiitis obliterans patients (Buerger's disease or TAO)
|
|
Control group
200 atheromatous arteritis patients
|
Detailed Description:
We include 200 Buerger's disease patients and 200 atheromatous arteritis patients, smoking tobacco or cannabis. First visit explores psychiatric disorders with MINI DSM IV (Lecrubier et al 1997), personality disorders with SCID II (Structured Clinical Interview for DSM IV); Addictive profile and Substance Use (or abuse) is evaluated with specific questionnaires (Rapid Addictive Profile, Fagerström and Cannabis questionnaire); Neuropsychological tests (Frontal Assessment Battery at bedside Dubois et al 2000; Stroop test , Stroop 1935); clinical assessment of the illness (Buerger and Atheromatous arteritis); and psychoactive substance and cotinine detection in urine. A second visit one year later will be realized with same assessments.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
We include 200 Buerger's disease patients and 200 atheromatous arteritis patients, smoking tobacco or cannabis
Inclusion Criteria:
- Buerger's disease patients or atheromatous arteritis patients
- Smoking tobacco or cannabis
Exclusion Criteria:
- Diabetic patients
Contacts and Locations| Contact: Olivier COTTENCIN | 033 3 20 44 58 38 | olivier.cottencin@chru-lille.fr |
| Contact: Anne-Laure DEMARTY | 033 3 20 44 68 91 | anne-laure.demarty@chru-lille.fr |
| France | |
| University Hospital, Bordeaux | Recruiting |
| Bordeaux, France | |
| Principal Investigator: Joel CONSTANS | |
| Sub-Investigator: Marc AURIACOMBE | |
| University Hospital, Brest | Recruiting |
| Brest, France | |
| Principal Investigator: Luc BRESSOLLETTE | |
| Sub-Investigator: Myriam CHASTAING | |
| University Hospital, Caen | Recruiting |
| Caen, France | |
| Principal Investigator: Claire LE HELLO | |
| University Hospital, Lille | Recruiting |
| Lille, France | |
| Principal Investigator: Marc LAMBERT | |
| Sub-Investigator: Stéphane DUHEM | |
| Sub-Investigator: Anne-Sophie JEAN | |
| University Hospital, Marseille | Recruiting |
| Marseille, France | |
| Principal Investigator: Alain BRANCHEREAU | |
| Sub-Investigator: Gabrielle SARLON | |
| Sub-Investigator: Christophe LANCON | |
| University Hospital, Montpellier | Recruiting |
| Montpellier, France | |
| Principal Investigator: Isabelle QUERE | |
| Sub-Investigator: Philippe COURTET | |
| University Hospital, Nancy | Recruiting |
| Nancy, France | |
| Principal Investigator: Denis WAHL | |
| University Hospital, Nantes | Active, not recruiting |
| Nantes, France | |
| Georges Pompidou European Hospital, Paris | Recruiting |
| Paris, France | |
| Principal Investigator: Jean-Noel FIESSINGER | |
| Sub-Investigator: Silla CONSOLI | |
| Tenon Hospital, Paris | Terminated |
| Paris, France | |
| University Hospital, Rouen | Active, not recruiting |
| Rouen, France | |
| University Hospital, Strasbourg | Recruiting |
| Strasbourg, France | |
| Principal Investigator: Dominique STEPHAN | |
| University Hospital, Toulouse | Recruiting |
| Toulouse, France | |
| Principal Investigator: Alessandra BURA-RIVIERE | |
| University Hospital, Tours | Recruiting |
| Tours, France | |
| Principal Investigator: Jean-Louis GUILMOT | |
| Sub-Investigator: Vincent CAMUS | |
| General Hospital, Valenciennes | Recruiting |
| Valenciennes, France | |
| Principal Investigator: Thomas QUEMENEUR | |
| Sub-Investigator: Marc PAVAUT | |
| Sub-Investigator: Xavier KYNDT | |
| Paul Brousse Hospital, Villejuif | Active, not recruiting |
| Villejuif, France | |
| Principal Investigator: | Olivier COTTENCIN | University Hospital, Lille |
More Information
No publications provided
| Responsible Party: | University Hospital, Lille |
| ClinicalTrials.gov Identifier: | NCT01064206 History of Changes |
| Other Study ID Numbers: | 2008-A00378-47, 2008_03/0814, PHRC 2008/1915 |
| Study First Received: | February 5, 2010 |
| Last Updated: | April 13, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Lille:
|
thrombangiitis obliterans Buerger's disease atheromatous arteritis psychiatric disorders personality disorders |
addictive profile addiction tobacco cannabis |
Additional relevant MeSH terms:
|
Arteritis Thromboangiitis Obliterans Vascular Diseases |
Cardiovascular Diseases Vasculitis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on June 17, 2013