ADDICTAO: Psychological and Addictive Profile of Patients With Buerger's Disease

NCT ID: NCT01064206

Last Updated: 2016-11-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 224 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2016-09-30

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.

Conditions

Thromboangiitis Obliterans; Atheromatous Arteritis

Keywords

thrombangiitis obliterans; Buerger's disease; atheromatous arteritis; psychiatric disorders; personality disorders; addictive profile; addiction; tobacco; cannabis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Buerger's disease patients

200 thromboangiitis obliterans patients (Buerger's disease or TAO)

No interventions assigned to this group

Control group

200 atheromatous arteritis patients

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Diabetic patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Lille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Olivier COTTENCIN

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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

Countries

France

Other Identifiers

2008-A00378-47

Identifier Type: OTHER

Identifier Source: secondary_id

PHRC 2008/1915

Identifier Type: OTHER

Identifier Source: secondary_id

2008_03/0814

Identifier Type: -

Identifier Source: org_study_id