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

Not Applicable

Terminated

• Conditions: Alcoholic; Volunteers; Volunteers Repeated Drug Poisoning
• Interventions: Other: MRI and biological assessment

• Registration Number: NCT02889042
• Lead Sponsor: University Hospital, Grenoble

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 .

Study Timeline

• Study Start: 2016-07-19
• Primary Completion: 2016-07-19
• Study Completion: 2016-07-19
• Study First Submitted: 2016-08-03
• Study First Submitted QC: 2016-08-30
• Study First Posted: 2016-09-05
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-26
• Last Update Posted: 2019-12-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Volunteers repeated drug poisoning	MRI and biological assessment	performing MRI and a biological assessment
alcoholic	MRI and biological assessment	performing MRI and a biological assessment
Volunteers single drug poisoning	MRI and biological assessment	performing MRI and a biological assessment
volunteers	MRI and biological assessment	performing MRI and a biological assessment

Primary Outcome Measures

Name	Time	Method
Comparison of local measurements of changes in the BOLD (Blood Oxygenation Level Dependent) based on visual stimuli by anatomical and functional MRI	15 days of the passage to the act

Trial Locations

Locations (1)

University Hospital Grenoble; 🇫🇷 Grenoble, France