Repeated Voluntary Drug Intoxication (IMVr): Characterization of a New Addictive Behavior by Clinical Phenotyping and Functional Imaging (Phenot IMVr)

December 26, 2019 updated by: University Hospital, Grenoble
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.

Study Overview

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

Interventional

Enrollment (Actual)

1

Phase

  • Not Applicable

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

      • Grenoble, France, 38043
        • University Hospital Grenoble

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

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

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

  • 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

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

Investigators

  • Principal Investigator: PENNEL Lucie, University Hospital, Grenoble

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 (Actual)

July 19, 2016

Primary Completion (Actual)

July 19, 2016

Study Completion (Actual)

July 19, 2016

Study Registration Dates

First Submitted

August 3, 2016

First Submitted That Met QC Criteria

August 30, 2016

First Posted (Estimate)

September 5, 2016

Study Record Updates

Last Update Posted (Actual)

December 27, 2019

Last Update Submitted That Met QC Criteria

December 26, 2019

Last Verified

December 1, 2019

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)?

Undecided

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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