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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by University Hospital, Lille.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01064206
First received: February 5, 2010
Last updated: April 13, 2012
Last verified: March 2012

February 5, 2010
April 13, 2012
September 2008
September 2013   (final data collection date for primary outcome measure)
SCID personality disorders [ Time Frame: 2013 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01064206 on ClinicalTrials.gov Archive Site
  • psychiatric disorders by MINI DSM-IV results [ Time Frame: 2013 ] [ Designated as safety issue: No ]
  • RAP Fagerström and Cannabis questionnaire total scores [ Time Frame: 2013 ] [ Designated as safety issue: No ]
  • Results of neuropsychological assessment [ Time Frame: 2013 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
ADDICTAO: Psychological and Addictive Profile of Patients With Buerger's Disease
Study of Psychological and Addictive Profile of Patients With Buerger's Disease

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.

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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

urine

Non-Probability Sample

We include 200 Buerger's disease patients and 200 atheromatous arteritis patients, smoking tobacco or cannabis

  • Thromboangiitis Obliterans
  • Atheromatous Arteritis
Not Provided
  • Buerger's disease patients
    200 thromboangiitis obliterans patients (Buerger's disease or TAO)
  • Control group
    200 atheromatous arteritis patients
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
400
September 2013
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetic patients
Both
18 Years and older
No
Contact: Olivier COTTENCIN 033 3 20 44 58 38 olivier.cottencin@chru-lille.fr
Contact: Anne-Laure DEMARTY 033 3 20 44 68 91 anne-laure.demarty@chru-lille.fr
France
 
NCT01064206
2008-A00378-47, 2008_03/0814, PHRC 2008/1915
No
University Hospital, Lille
University Hospital, Lille
Not Provided
Principal Investigator: Olivier COTTENCIN University Hospital, Lille
University Hospital, Lille
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP