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.
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
- Conditions the study is for
- Thromboangiitis Obliterans, Atheromatous Arteritis
- 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
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.
- Conditions
- Thromboangiitis Obliterans, Atheromatous Arteritis
- 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 group | Role | What they receive |
|---|---|---|
| Buerger's disease patients | 200 thromboangiitis obliterans patients (Buerger's disease or TAO) | |
| Control group | 200 atheromatous arteritis patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCID personality disorders
Measured: 2013
Secondary outcomes (3)
psychiatric disorders by MINI DSM-IV results
Measured: 2013
RAP Fagerström and Cannabis questionnaire total scores
Measured: 2013
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.
- First posted8 Feb 2010 (estimated)
- Study startSep 2008
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thromboangiitis ObliteransStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier COTTENCIN, Principal investigator, University Hospital, Lille
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
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Psychological and Addictive Profile of Patients With Buerger's Disease
- ClinicalTrials.gov ID
- NCT01064206
- Acronym / sponsor ID
- ADDICTAO / 2008_03/0814
- Conditions
- Thromboangiitis Obliterans, Atheromatous Arteritis
- Keywords
- thrombangiitis obliterans, Buerger's disease, atheromatous arteritis, psychiatric disorders, personality disorders, addictive profile, addiction, tobacco
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 8 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buerger's disease patients | – | –200 thromboangiitis obliterans patients (Buerger's disease or TAO) |
| Control group | – | –200 atheromatous arteritis patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- We include 200 Buerger's disease patients and 200 atheromatous arteritis patients, smoking tobacco or cannabis
Key inclusion criteria (2 listed)
- Buerger's disease patients or atheromatous arteritis patients
- Smoking tobacco or cannabis
Key exclusion criteria (1 listed)
- Diabetic patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
SCID personality disorders
Time frame: 2013
3 secondary outcomes
psychiatric disorders by MINI DSM-IV results
Time frame: 2013
RAP Fagerström and Cannabis questionnaire total scores
Time frame: 2013
Results of neuropsychological assessment
Time frame: 2013
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier COTTENCIN principal investigator
University Hospital, Lille
16 sites in 1 country: see every site and its status.
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.