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

Thromboangiitis Obliterans Clinical Trial

— ADDICTAO  

Official title:

Study of Psychological and Addictive Profile of Patients With Buerger's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01064206
• Other study ID #: 2008_03/0814
• Secondary ID: 2008-A00378-47PH
• Status: Completed
• Phase: N/A
• First received: February 5, 2010
• Last updated: November 9, 2016
• Start date: September 2008
• Est. completion date: September 2016

Study information

• Verified date: November 2016
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 224
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Buerger's disease patients or atheromatous arteritis patients

• Smoking tobacco or cannabis

Exclusion Criteria:

• Diabetic patients

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arteritis
• Atheromatous Arteritis
• Thromboangiitis Obliterans

Locations

Country	Name	City	State
France	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCID personality disorders		2013	No
Secondary	psychiatric disorders by MINI DSM-IV results		2013	No
Secondary	RAP Fagerström and Cannabis questionnaire total scores		2013	No
Secondary	Results of neuropsychological assessment		2013	No