Volunteers Repeated Drug PoisoningPhenot IMVrNCT02889042
Repeated Voluntary Drug Intoxication (IMVr): Characterization of a New Addictive Behavior by Clinical Phenotyping and Functional Imaging
A study testing MRI and biological assessment in people with Volunteers Repeated Drug Poisoning and Alcoholic, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Volunteers Repeated Drug Poisoning, Alcoholic, Volunteers
- What is being tested?
- MRI and biological assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jul 2016to 19 Jul 2016
- Phase
- Interventional
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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 .
- Conditions
- Volunteers Repeated Drug Poisoning, Alcoholic, Volunteers
- Being tested
- MRI and biological assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI and biological assessmentOther
performing a MRI and a biological assessment
| Study group | Role | What they receive |
|---|---|---|
| Volunteers repeated drug poisoning | Experimental | performing MRI and a biological assessment Receives: Other: MRI and biological assessment |
| Volunteers single drug poisoning | Other | performing MRI and a biological assessment Receives: Other: MRI and biological assessment |
| alcoholic | Other | performing MRI and a biological assessment Receives: Other: MRI and biological assessment |
| volunteers | Other | performing MRI and a biological assessment Receives: Other: MRI and biological assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of local measurements of changes in the BOLD (Blood Oxygenation Level Dependent) based on visual stimuli by anatomical and functional MRI
Measured: 15 days of the passage to the act
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study start19 Jul 2016
- Primary completion19 Jul 2016
- Study completion19 Jul 2016
Why it stopped: not enough patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Volunteers Repeated Drug PoisoningStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PENNEL Lucie, Principal investigator, University Hospital, Grenoble
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889042
- Sponsor's protocol ID
- 38RC14.182
- Acronym
- Phenot IMVr
- Status last verified
- Dec 2019
- First submitted
- 3 Aug 2016
- Last updated
- 27 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repeated Voluntary Drug Intoxication (IMVr): Characterization of a New Addictive Behavior by Clinical Phenotyping and Functional Imaging
- ClinicalTrials.gov ID
- NCT02889042
- Acronym / sponsor ID
- Phenot IMVr / 38RC14.182
- Conditions
- Volunteers Repeated Drug Poisoning, Alcoholic, Volunteers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough patients
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 19 Jul 2016 (actual)
- Primary completion
- 19 Jul 2016 (actual)
- Study completion
- 19 Jul 2016 (actual)
- First posted
- 5 Sep 2016 (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.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Volunteers repeated drug poisoning | Experimental | Other: MRI and biological assessmentperforming MRI and a biological assessment |
| Volunteers single drug poisoning | Other | Other: MRI and biological assessmentperforming MRI and a biological assessment |
| alcoholic | Other | Other: MRI and biological assessmentperforming MRI and a biological assessment |
| volunteers | Other | Other: MRI and biological assessmentperforming MRI and a biological assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Man or woman hospitalized (e) in the aftermath of a IMV:
- 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
- Age greater than or equal to 18 and less than or equal to 60 years
- Informed consent in writing signed by the patient
Key exclusion criteria (16 listed)
- Have a history of scarification or addictive disorder (behavioral or product)
- TS present history
- Age less than 18 years, over 60 years.
- acute or chronic delusional disorder.
- Cognitive impairment or impeding the reading comprehension quizzes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI and biological assessmentperforming a MRI and a biological assessment | Other | Volunteers repeated drug poisoning, Volunteers single drug poisoning, alcoholic, volunteers |
Primary outcome
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
Results and safety
The study was stopped early (reason given: not enough patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2019.
- Individual participant dataSharing planned: Undecided
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.
PENNEL Lucie principal investigator
University Hospital, Grenoble
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI and biological assessment in people with Volunteers Repeated Drug Poisoning and Alcoholic, run by University Hospital, Grenoble at 1 site 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 10 inclusion and 16 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: stopped early, as of the sponsor's last update on 27 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: not enough patients). Results are not available in the source record.
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?
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). 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 27 Dec 2019.