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Thromboangiitis ObliteransADDICTAONCT01064206

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

An observational study of Thromboangiitis Obliterans and Atheromatous Arteritis, run by University Hospital, Lille at 16 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
How many people
224 participants
Where
16 sitesFrance
Study dates
Sep 2008to Sep 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • Diabetic patients

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

France16 sites
  • University Hospital, Bordeaux

    Bordeaux

  • University Hospital, Brest

    Brest

  • University Hospital, Caen

    Caen

  • University Hospital, Lille

    Lille

  • University Hospital, Marseille

    Marseille

  • University Hospital, Montpellier

    Montpellier

  • University Hospital, Nancy

    Nancy

  • University Hospital, Nantes

    Nantes

  • Georges Pompidou European Hospital, Paris

    Paris

  • Tenon Hospital, Paris

    Paris

  • University Hospital, Rouen

    Rouen

  • University Hospital, Strasbourg

    Strasbourg

  • University Hospital, Toulouse

    Toulouse

  • University Hospital, Tours

    Tours

  • General Hospital, Valenciennes

    Valenciennes

  • Paul Brousse Hospital, Villejuif

    Villejuif

Other trials in France

About this study

Official title: 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.

Read more

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.

Read the 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.

Keywords
thrombangiitis obliterans, Buerger's disease, atheromatous arteritis, psychiatric disorders, personality disorders, addictive profile, addiction, tobacco, cannabis
Medical subject headings
Thromboangiitis Obliterans, Mental Disorders, Personality Disorders, Behavior, Addictive, Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01064206
Study groupRoleWhat they receive
Buerger's disease patients200 thromboangiitis obliterans patients (Buerger's disease or TAO)
Control group200 atheromatous arteritis patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SCID personality disorders

    Measured: 2013

Secondary outcomes (3)
  1. psychiatric disorders by MINI DSM-IV results

    Measured: 2013

  2. RAP Fagerström and Cannabis questionnaire total scores

    Measured: 2013

  3. Results of neuropsychological assessment

    Measured: 2013

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2010 (estimated)
  2. Study startSep 2008
  3. Primary completionSep 2016
  4. Study completionSep 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01064206
Sponsor's protocol ID
2008_03/0814
Other IDs
2008-A00378-47, PHRC 2008/1915
Acronym
ADDICTAO
Status last verified
Nov 2016
First submitted
5 Feb 2010
Last updated
10 Nov 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Thromboangiitis Obliterans and Atheromatous Arteritis, run by University Hospital, Lille at 16 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SCID personality disorders (time frame: 2013). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2016.

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