ADDICTAO: Psychological and Addictive Profile of Patients With Buerger's Disease
ADDICTAO
Study of Psychological and Addictive Profile of Patients With Buerger's Disease
3 other identifiers
observational
224
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Sep 2008
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 5, 2010
CompletedFirst Posted
Study publicly available on registry
February 8, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2016
CompletedNovember 10, 2016
November 1, 2016
8 years
February 5, 2010
November 9, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
SCID personality disorders
2013
Secondary Outcomes (3)
psychiatric disorders by MINI DSM-IV results
2013
RAP Fagerström and Cannabis questionnaire total scores
2013
Results of neuropsychological assessment
2013
Study Arms (2)
Buerger's disease patients
200 thromboangiitis obliterans patients (Buerger's disease or TAO)
Control group
200 atheromatous arteritis patients
Eligibility Criteria
We include 200 Buerger's disease patients and 200 atheromatous arteritis patients, smoking tobacco or cannabis
You may qualify if:
- Buerger's disease patients or atheromatous arteritis patients
- Smoking tobacco or cannabis
You may not qualify if:
- Diabetic patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
University Hospital, Bordeaux
Bordeaux, France
University Hospital, Brest
Brest, France
University Hospital, Caen
Caen, France
University Hospital, Lille
Lille, France
University Hospital, Marseille
Marseille, France
University Hospital, Montpellier
Montpellier, France
University Hospital, Nancy
Nancy, France
University Hospital, Nantes
Nantes, France
Georges Pompidou European Hospital, Paris
Paris, France
Tenon Hospital, Paris
Paris, France
University Hospital, Rouen
Rouen, France
University Hospital, Strasbourg
Strasbourg, France
University Hospital, Toulouse
Toulouse, France
University Hospital, Tours
Tours, France
General Hospital, Valenciennes
Valenciennes, France
Paul Brousse Hospital, Villejuif
Villejuif, France
Biospecimen
urine
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olivier COTTENCIN
University Hospital, Lille
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2010
First Posted
February 8, 2010
Study Start
September 1, 2008
Primary Completion
September 1, 2016
Study Completion
September 1, 2016
Last Updated
November 10, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share