- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02889042
Repeated Voluntary Drug Intoxication (IMVr): Characterization of a New Addictive Behavior by Clinical Phenotyping and Functional Imaging (Phenot IMVr)
Study Overview
Status
Intervention / Treatment
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 .
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Grenoble, France, 38043
- University Hospital Grenoble
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Volunteers repeated drug poisoning
performing MRI and a biological assessment
|
performing a MRI and a biological assessment
|
Other: Volunteers single drug poisoning
performing MRI and a biological assessment
|
performing a MRI and a biological assessment
|
Other: alcoholic
performing MRI and a biological assessment
|
performing a MRI and a biological assessment
|
Other: volunteers
performing MRI and a biological assessment
|
performing a MRI and a biological assessment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
15 days of the passage to the act
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: PENNEL Lucie, University Hospital, Grenoble
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC14.182
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
Clinical Trials on Volunteers
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
University Hospital, Clermont-FerrandInstitut de Médecine du Travail; UMR CNRS 6024, LaPSCoRecruiting
-
McMaster UniversityOntario Ministry of Health and Long Term Care; Canadian Red Cross; David BraleyCompleted
-
Medtronic Cardiac Rhythm and Heart FailureCompleted
-
Göteborg UniversityRecruiting
Clinical Trials on MRI and biological assessment
-
University Hospital, ToursInstitut National de la Santé Et de la Recherche Médicale, France; EchosensUnknown
-
University of Michigan Rogel Cancer CenterDepartment of Health and Human ServicesCompleted
-
Pr. Nicolas GIRERDCompletedCardiovascular DiseasesFrance
-
University Hospital, MontpellierCompletedMajor Depressive Disorders
-
Fondazione Policlinico Universitario Agostino Gemelli...RecruitingMeningioma | Anaplastic Meningioma | Meningioma AtypicalItaly
-
University of Southern CaliforniaNational Cancer Institute (NCI)RecruitingHypogonadism | Malignant Testicular Germ Cell TumorUnited States
-
University Hospital, CaenInstitut National de la Santé Et de la Recherche Médicale, FranceUnknown
-
Institut National de la Santé Et de la Recherche...Karolinska Institutet; University Hospital, Bonn; Institut d'Investigacions Biomèdiques... and other collaboratorsCompletedParkinson's Disease | Alzheimer's DiseaseFrance, Germany, Spain, Sweden
-
University Hospital, LilleConseil Régional Hauts-de-France, France; Fondation pour la recherche sur les...Not yet recruitingStroke | Intra Cerebral Hemorrhage
-
Istituto Ortopedico RizzoliWithdrawn