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

November 9, 2016 updated by: University Hospital, Lille

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

224

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France
        • University Hospital, Bordeaux
      • Brest, France
        • University Hospital, Brest
      • Caen, France
        • University Hospital, Caen
      • Lille, France
        • University Hospital, Lille
      • Marseille, France
        • University Hospital, Marseille
      • Montpellier, France
        • University Hospital, Montpellier
      • Nancy, France
        • University Hospital, Nancy
      • Nantes, France
        • University Hospital, Nantes
      • Paris, France
        • Georges Pompidou European Hospital, Paris
      • Paris, France
        • Tenon Hospital, Paris
      • Rouen, France
        • University Hospital, Rouen
      • Strasbourg, France
        • University Hospital, Strasbourg
      • Toulouse, France
        • University Hospital, Toulouse
      • Tours, France
        • University Hospital, Tours
      • Valenciennes, France
        • General Hospital, Valenciennes
      • Villejuif, France
        • Paul Brousse Hospital, Villejuif

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Diabetic patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
SCID personality disorders
Time Frame: 2013
2013

Secondary Outcome Measures

Outcome Measure
Time Frame
psychiatric disorders by MINI DSM-IV results
Time Frame: 2013
2013
RAP Fagerström and Cannabis questionnaire total scores
Time Frame: 2013
2013
Results of neuropsychological assessment
Time Frame: 2013
2013

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Olivier COTTENCIN, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

February 5, 2010

First Submitted That Met QC Criteria

February 5, 2010

First Posted (Estimate)

February 8, 2010

Study Record Updates

Last Update Posted (Estimate)

November 10, 2016

Last Update Submitted That Met QC Criteria

November 9, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008_03/0814
  • 2008-A00378-47 (Other Identifier: ID-RCB number, ANSM)
  • PHRC 2008/1915 (Other Identifier: DHOS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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