Back to resultsRepeated Voluntary Drug Intoxication (IMVr): Characterization of a New Addictive Behavior by Clinical Phenotyping and Functional Imaging (Phenot IMVr)
Primary Purpose
Volunteers Repeated Drug Poisoning, Alcoholic, Volunteers
Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI and biological assessment
Sponsored by
About this trial
This is an interventional diagnostic trial for Volunteers Repeated Drug Poisoning
Eligibility Criteria
Inclusion Criteria:
Will be offered for study subjects that meet the following criteria:
Man or woman hospitalized (e) in the aftermath of a IMV:
- History of at least 2 for the IMV group IMVr
- First suicide attempt high intentionality (SIS score> 20/30) for group IMVS
- Man or woman with alcohol dependence according to DSM-IV-TR, in the aftermath of withdrawal (outpatient or inpatient) for the alcohol group
- Man or woman free from any addictive disorder, suicidal or mood for the control group
And all of the following criteria:
- Age greater than or equal to 18 and less than or equal to 60 years
- Informed consent in writing signed by the patient
- Person affiliated to the social security or beneficiary of such a scheme
Exclusion Criteria:
For IMVS Group:
- Have a history of scarification or addictive disorder (behavioral or product)
In the alcohol group:
- TS present history
For all patients, presenting at least one of the following criteria:
- Age less than 18 years, over 60 years.
- acute or chronic delusional disorder.
- Cognitive impairment or impeding the reading comprehension quizzes.
- secondary pathologies at a stroke.
- Denial of participation.
- Contraindications to MRI.
- Subjects with clinically significant gastrointestinal, renal, hepatic, endocrine, cardiovascular or respiratory (especially persistent asthma) which can prevent stay of 60 min in MRI without being hindered.
- No participant to another pharmacological study.
- unauthorized treatments: all psychotropic treatments (except anti-anxiety treatments benzodiazepine average duration of action and antihistamine), baclofen and other treatment can modify vasoreactivity fMRI.
- Coagulation disorders against-indicating blood.
- People under guardianship
Sites / Locations
- University Hospital Grenoble
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Other
Other
Other
Arm Label
Volunteers repeated drug poisoning
Volunteers single drug poisoning
alcoholic
volunteers
Arm Description
performing MRI and a biological assessment
performing MRI and a biological assessment
performing MRI and a biological assessment
performing MRI and a biological assessment
Outcomes
Primary Outcome Measures
Comparison of local measurements of changes in the BOLD (Blood Oxygenation Level Dependent) based on visual stimuli by anatomical and functional MRI
Secondary Outcome Measures
Full Information
NCT ID
NCT02889042
First Posted
August 3, 2016
Last Updated
December 26, 2019
Sponsor
University Hospital, Grenoble
1. Study Identification
Unique Protocol Identification Number
NCT02889042
Brief Title
Repeated Voluntary Drug Intoxication (IMVr): Characterization of a New Addictive Behavior by Clinical Phenotyping and Functional Imaging
Acronym
Phenot IMVr
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Terminated
Why Stopped
not enough patients
Study Start Date
July 19, 2016 (Actual)
Primary Completion Date
July 19, 2016 (Actual)
Study Completion Date
July 19, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
France is one of the European countries with the highest rate of death by suicide, more than 10 400 deaths each year, about 16 people out of 100 000. Although suicide mortality rate tends to fall between 1987 and 2008 the number of suicide attempts (TS) against observed by an upward trend between 2005 and 2010. However, the most important predictor of death by suicide remains the TS. Now these are primarily TS Poisoning Drug-Volunteer (IMV), especially benzodiazepines. These IMV, there have been 16% recurrence in the past year and 21% at 4 years among hospitalized patients. Or a Health Barometer 2005 survey showed that 58% of respondents with a TS over the last 12 months had not been hospitalized. This type of acting out, especially the repeated IMV (IMVr) is underestimated epidemiologically because it is an unknown phenomenon and too little screened by health professionals.
Detailed Description
The IMVr constitute severe behavior disorder, chronic and costly given the multiple prescriptions, hospital admissions, including emergencies, and repeated treatment failures, in the absence of specific treatment of psychopathological problematic background. Indeed many arguments lead to evoke the existence of a functioning underlying addictive type, rather than a problem of suicide, especially from the second recurrence (often characterized by low lethality and suicidal intentionality). This impulsive behavior and / or compulsive repeatedly would not simply the consequence of a pharmacological benzodiazepine dependence (it is also not systematic), but would demonstrate a similar operation to that of behavioral addictions. Furthermore, a preliminary study has shown that this type of behavior was not limited to a BPD personality type, since it is mainly found pathological personalities depressive and avoidant types.
In this context it is urgent to make an accurate characterization of these patients IMVr because the integration of the addictive dimension in their care will adapt strategies psychotherapeutic, pharmacological, and the terms of issue of psychotropic and especially benzodiazepines .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Volunteers Repeated Drug Poisoning, Alcoholic, Volunteers
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Volunteers repeated drug poisoning
Arm Type
Experimental
Arm Description
performing MRI and a biological assessment
Arm Title
Volunteers single drug poisoning
Arm Type
Other
Arm Description
performing MRI and a biological assessment
Arm Title
alcoholic
Arm Type
Other
Arm Description
performing MRI and a biological assessment
Arm Title
volunteers
Arm Type
Other
Arm Description
performing MRI and a biological assessment
Intervention Type
Other
Intervention Name(s)
MRI and biological assessment
Intervention Description
performing a MRI and a biological assessment
Primary Outcome Measure Information:
Title
Comparison of local measurements of changes in the BOLD (Blood Oxygenation Level Dependent) based on visual stimuli by anatomical and functional MRI
Time Frame
15 days of the passage to the act
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Will be offered for study subjects that meet the following criteria:
Man or woman hospitalized (e) in the aftermath of a IMV:
History of at least 2 for the IMV group IMVr
First suicide attempt high intentionality (SIS score> 20/30) for group IMVS
Man or woman with alcohol dependence according to DSM-IV-TR, in the aftermath of withdrawal (outpatient or inpatient) for the alcohol group
Man or woman free from any addictive disorder, suicidal or mood for the control group
And all of the following criteria:
Age greater than or equal to 18 and less than or equal to 60 years
Informed consent in writing signed by the patient
Person affiliated to the social security or beneficiary of such a scheme
Exclusion Criteria:
For IMVS Group:
Have a history of scarification or addictive disorder (behavioral or product)
In the alcohol group:
TS present history
For all patients, presenting at least one of the following criteria:
Age less than 18 years, over 60 years.
acute or chronic delusional disorder.
Cognitive impairment or impeding the reading comprehension quizzes.
secondary pathologies at a stroke.
Denial of participation.
Contraindications to MRI.
Subjects with clinically significant gastrointestinal, renal, hepatic, endocrine, cardiovascular or respiratory (especially persistent asthma) which can prevent stay of 60 min in MRI without being hindered.
No participant to another pharmacological study.
unauthorized treatments: all psychotropic treatments (except anti-anxiety treatments benzodiazepine average duration of action and antihistamine), baclofen and other treatment can modify vasoreactivity fMRI.
Coagulation disorders against-indicating blood.
People under guardianship
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PENNEL Lucie
Organizational Affiliation
University Hospital, Grenoble
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Repeated Voluntary Drug Intoxication (IMVr): Characterization of a New Addictive Behavior by Clinical Phenotyping and Functional Imaging
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