Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01064206
Recruitment Status : Completed
First Posted : February 8, 2010
Last Update Posted : November 10, 2016
Information provided by (Responsible Party):
University Hospital, Lille

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.

Condition or disease
Thromboangiitis Obliterans 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 224 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Study of Psychological and Addictive Profile of Patients With Buerger's Disease
Study Start Date : September 2008
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

Buerger's disease patients
200 thromboangiitis obliterans patients (Buerger's disease or TAO)
Control group
200 atheromatous arteritis patients

Primary Outcome Measures :
  1. SCID personality disorders [ Time Frame: 2013 ]

Secondary Outcome Measures :
  1. psychiatric disorders by MINI DSM-IV results [ Time Frame: 2013 ]
  2. RAP Fagerström and Cannabis questionnaire total scores [ Time Frame: 2013 ]
  3. Results of neuropsychological assessment [ Time Frame: 2013 ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01064206

Layout table for location information
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
Sponsors and Collaborators
University Hospital, Lille
Layout table for investigator information
Principal Investigator: Olivier COTTENCIN University Hospital, Lille

Layout table for additonal information
Responsible Party: University Hospital, Lille Identifier: NCT01064206     History of Changes
Other Study ID Numbers: 2008_03/0814
2008-A00378-47 ( Other Identifier: ID-RCB number, ANSM )
PHRC 2008/1915 ( Other Identifier: DHOS )
First Posted: February 8, 2010    Key Record Dates
Last Update Posted: November 10, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Lille:
thrombangiitis obliterans
Buerger's disease
atheromatous arteritis
psychiatric disorders
personality disorders
addictive profile
Additional relevant MeSH terms:
Layout table for MeSH terms
Thromboangiitis Obliterans
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases