Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille
ClinicalTrials.gov Identifier:
NCT01064206
First received: February 5, 2010
Last updated: November 9, 2016
Last verified: November 2016
  Purpose

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
Thromboangiitis Obliterans
Atheromatous Arteritis

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Study of Psychological and Addictive Profile of Patients With Buerger's Disease

Resource links provided by NLM:


Further study details as provided by University Hospital, Lille:

Primary Outcome Measures:
  • SCID personality disorders [ Time Frame: 2013 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples Without DNA
urine

Enrollment: 224
Study Start Date: September 2008
Study Completion Date: September 2016
Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Buerger's disease patients
200 thromboangiitis obliterans patients (Buerger's disease or TAO)
Control group
200 atheromatous arteritis patients

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetic patients
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01064206

Locations
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, France
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Olivier COTTENCIN University Hospital, Lille
  More Information

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT01064206     History of Changes
Other Study ID Numbers: 2008_03/0814  2008-A00378-47  PHRC 2008/1915 
Study First Received: February 5, 2010
Last Updated: November 9, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University Hospital, Lille:
thrombangiitis obliterans
Buerger's disease
atheromatous arteritis
psychiatric disorders
personality disorders
addictive profile
addiction
tobacco
cannabis

Additional relevant MeSH terms:
Arteritis
Thromboangiitis Obliterans
Vasculitis
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on December 09, 2016