Clinical trial NCT01064206: ADDICTAO: Psychological and Addictive Profile of Patients With Buerger's Disease
Official title: Study of Psychological and Addictive Profile of Patients With Buerger's Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thromboangiitis Obliterans
Atheromatous Arteritis
Keywords: thrombangiitis obliterans
Buerger's disease
atheromatous arteritis
psychiatric disorders
personality disorders
addictive profile
addiction
tobacco
cannabis
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2010-02-08
Enrollment: 224
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We include 200 Buerger's disease patients and 200 atheromatous arteritis patients, smoking tobacco or cannabis

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.

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 criteria: Inclusion Criteria:

* Buerger's disease patients or atheromatous arteritis patients
* Smoking tobacco or cannabis

Exclusion Criteria:

* Diabetic patients

Primary outcomes:
measure: SCID personality disorders
timeFrame: 2013
Secondary outcomes:
measure: psychiatric disorders by MINI DSM-IV results
timeFrame: 2013
measure: RAP Fagerström and Cannabis questionnaire total scores
timeFrame: 2013
measure: Results of neuropsychological assessment
timeFrame: 2013
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: University Hospital, Bordeaux
city: Brest
country: France
facility: University Hospital, Brest
city: Caen
country: France
facility: University Hospital, Caen
city: Lille
country: France
facility: University Hospital, Lille
city: Marseille
country: France
facility: University Hospital, Marseille
city: Montpellier
country: France
facility: University Hospital, Montpellier
city: Nancy
country: France
facility: University Hospital, Nancy
city: Nantes
country: France
facility: University Hospital, Nantes
city: Paris
country: France
facility: Georges Pompidou European Hospital, Paris
city: Paris
country: France
facility: Tenon Hospital, Paris
city: Rouen
country: France
facility: University Hospital, Rouen
city: Strasbourg
country: France
facility: University Hospital, Strasbourg
city: Toulouse
country: France
facility: University Hospital, Toulouse
city: Tours
country: France
facility: University Hospital, Tours
city: Valenciennes
country: France
facility: General Hospital, Valenciennes
city: Villejuif
country: France
facility: Paul Brousse Hospital, Villejuif
Study officials:
affiliation: University Hospital, Lille
name: Olivier COTTENCIN
role: PRINCIPAL_INVESTIGATOR
References: