Hospitalized for Voluntary Drug IntoxicationDEFIMED-1NCT02869724
Divided Drug Delivery
A study testing Weekly divided delivery and Monthly divided delivery in people with Hospitalized for Voluntary Drug Intoxication, run by University Hospital, Grenoble at 1 site in France.
Trial summary
This study will evaluate the efficacy of an advice with a weekly divided drug delivery, compared to an usual monthly delivery in the prevention of voluntary drug intoxications repeated. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hospitalized for Voluntary Drug Intoxication
- What is being tested?
- Weekly divided delivery and Monthly divided delivery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Mar 2017
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women between 18 and 65 years.
- Hospitalized after a voluntary drug intoxication.
- History of two voluntary drug intoxications at least.
- Person registered for social security.
- Signed free consent.
Who cannot join
- Patients under treatment for opiate split
- Acute or chronicgoing wild.
- Cognitive problems hindering understanding of questionnaires
- Persons targeted by articles L1121-5 to L1121-8 of CSP
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
UniversityHospitalGrenoble
La Tronche, 38700
Maurice Dematteis, Professor, +66236, MDematteis@chu-grenoble.fr
Michel Mallaret, Doctor, 04 76 76 41 55, mmallaret@chu-grenoble.fr
About this study
Official title: Divided Drug Delivery : a Way to Prevent Repeated Volutary Drug Intoxications.
This study will evaluate the efficacy of an advice with a weekly divided drug delivery, compared to an usual monthly delivery in the prevention of voluntary drug intoxications repeated.
- Being tested
- Weekly divided delivery, Monthly divided delivery
- Keywords
- IMV : voluntary drug intoxications, Drug, Divided prescription
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly divided deliveryOther
Monthly divided deliveryOther
| Study group | Role | What they receive |
|---|---|---|
| Weekly divided delivery | Active comparator | Hospitalized for voluntary drug intoxications. Receives: Other: Weekly divided delivery |
| Monthly divided delivery | Active comparator | Hospitalized for voluntary drug intoxications. Receives: Other: Monthly divided delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of an advice with a weekly divided drug delivery, compared to an usual monthly delivery in the prevention of voluntary drug intoxications repeated
Number of cumulative voluntary drug intoxications throughout the 6 months
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2016 (estimated)
- Study startMar 2014
- Primary completionMar 2017 (estimated)
- Study completionMar 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (35)Papers the sponsor has linked to this study.
- Other trials for Hospitalized for Voluntary Drug IntoxicationStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maurice Dematteis, Professor, Principal investigator, Grenoble Hospital University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02869724
- Sponsor's protocol ID
- 38RC13.577
- Acronym
- DEFIMED-1
- Status last verified
- Jul 2016
- First submitted
- 27 Jul 2016
- Last updated
- 17 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Alonso J, Angermeyer MC, Bernert S, Bruffaerts R, Brugha TS, Bryson H, de Girolamo G, Graaf R, Demyttenaere K, Gasquet I, Haro JM, Katz SJ, Kessler RC, Kovess V, Lepine JP, Ormel J, Polidori G, Russo LJ, Vilagut G, Almansa J, Arbabzadeh-Bouchez S, Autonell J, Bernal M, Buist-Bouwman MA, Codony M, Domingo-Salvany A, Ferrer M, Joo SS, Martinez-Alonso M, Matschinger H, Mazzi F, Morgan Z, Morosini P, Palacin C, Romera B, Taub N, Vollebergh WA; ESEMeD/MHEDEA 2000 Investigators, European Study of the Epidemiology of Mental Disorders (ESEMeD) Project. Psychotropic drug utilization in Europe: results from the European Study of the Epidemiology of Mental Disorders (ESEMeD) project. Acta Psychiatr Scand Suppl. 2004;(420):55-64. doi: 10.1111/j.1600-0047.2004.00331.x.
PubMed 15128388Aouba, A., Péquignot, F., Camelin, L., Laurent, F., Jougla, E. La mortalité par suicide en France en 2006. Etudes et résultats. 2009 ; (702) : 1-8.
Beck, F., Guignard, R., Du Roscoät, E., Saïas, T. Tentatives de suicide et pensées suicidaires en France en 2010. Bulletin épidémiologique hebdomadaire. 2011 ; 47-48 : 488-492.
Camidge DR, Wood RJ, Bateman DN. The epidemiology of self-poisoning in the UK. Br J Clin Pharmacol. 2003 Dec;56(6):613-9. doi: 10.1046/j.1365-2125.2003.01910.x.
PubMed 14616420Carter GL, Clover K, Whyte IM, Dawson AH, D'Este C. Postcards from the EDge: 24-month outcomes of a randomised controlled trial for hospital-treated self-poisoning. Br J Psychiatry. 2007 Dec;191:548-53. doi: 10.1192/bjp.bp.107.038406.
PubMed 18055960Chan-Chee, C., & Jezewski-Serra, D. Hospitalisations pour tentatives de suicide entre 2004 et 2007 en France métropolitaine. Analyse du PMSI-MCO. Bulletin épidémiologique hebdomadaire. 2011 ; 47-48 : 492-496.
Coben JH, Davis SM, Furbee PM, Sikora RD, Tillotson RD, Bossarte RM. Hospitalizations for poisoning by prescription opioids, sedatives, and tranquilizers. Am J Prev Med. 2010 May;38(5):517-24. doi: 10.1016/j.amepre.2010.01.022.
PubMed 20409500Dumesnil, S., Grandfils, N., Le Fur, P., Mizrahi, A. Mizrahi, A. Santé, Soins et protection Sociale en France en 1996. CREDES (en ligne). Novembre 1997, (consulté le 3/4/12).
Fedyszyn IE, Harris MG, Robinson J, Edwards J, Paxton SJ. Characteristics of suicide attempts in young people undergoing treatment for first episode psychosis. Aust N Z J Psychiatry. 2011 Oct;45(10):838-45. doi: 10.3109/00048674.2011.595687. Epub 2011 Aug 23.
PubMed 21861593Florentine JB, Crane C. Suicide prevention by limiting access to methods: a review of theory and practice. Soc Sci Med. 2010 May;70(10):1626-32. doi: 10.1016/j.socscimed.2010.01.029. Epub 2010 Feb 12.
PubMed 20207465Fournet, N., Caillère, N., Fouillet, A., Caserio-Schönemann, C., Josseran, L. Le système français de surveillance sanitaire des urgences et des décès (Sur-SaUD®). Saint-Maurice : Institut de veille sanitaire : 2011. 12p.
Gasquet I, Negre-Pages L, Fourrier A, Nachbaur G, El-Hasnaoui A, Kovess V, Lepine JP. [Psychotropic drug use and mental psychiatric disorders in France; results of the general population ESEMeD/MHEDEA 2000 epidemiological study]. Encephale. 2005 Mar-Apr;31(2):195-206. doi: 10.1016/s0013-7006(05)82386-3. French.
PubMed 15959446Hawton K, van Heeringen K. Suicide. Lancet. 2009 Apr 18;373(9672):1372-81. doi: 10.1016/S0140-6736(09)60372-X.
PubMed 19376453Hovda KE, Bjornaas MA, Skog K, Opdahl A, Drottning P, Ekeberg O, Jacobsen D. Acute poisonings treated in hospitals in Oslo: a one-year prospective study (I): pattern of poisoning. Clin Toxicol (Phila). 2008 Jan;46(1):35-41. doi: 10.1080/15563650601185969.
PubMed 18167035Kapur N, Cooper J, Hiroeh U, May C, Appleby L, House A. Emergency department management and outcome for self-poisoning: a cohort study. Gen Hosp Psychiatry. 2004 Jan-Feb;26(1):36-41. doi: 10.1016/j.genhosppsych.2003.06.002.
PubMed 14757301
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Divided Drug Delivery : a Way to Prevent Repeated Volutary Drug Intoxications.
- ClinicalTrials.gov ID
- NCT02869724
- Acronym / sponsor ID
- DEFIMED-1 / 38RC13.577
- Keywords
- IMV : voluntary drug intoxications, Drug, Divided prescription
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Mar 2017 (estimated)
- First posted
- 17 Aug 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.
This study will evaluate the efficacy of an advice with a weekly divided drug delivery, compared to an usual monthly delivery in the prevention of voluntary drug intoxications repeated.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Weekly divided delivery | Active comparator | Other: Weekly divided deliveryHospitalized for voluntary drug intoxications. |
| Monthly divided delivery | Active comparator | Other: Monthly divided deliveryHospitalized for voluntary drug intoxications. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women between 18 and 65 years.
- Hospitalized after a voluntary drug intoxication.
- History of two voluntary drug intoxications at least.
- Person registered for social security.
- Signed free consent.
Key exclusion criteria (4 listed)
- Patients under treatment for opiate split
- Acute or chronicgoing wild.
- Cognitive problems hindering understanding of questionnaires
- Persons targeted by articles L1121-5 to L1121-8 of CSP
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 |
|---|---|---|
| Weekly divided delivery | Other | Weekly divided delivery |
| Monthly divided delivery | Other | Monthly divided delivery |
Primary outcome
Evaluate the efficacy of an advice with a weekly divided drug delivery, compared to an usual monthly delivery in the prevention of voluntary drug intoxications repeated
Time frame: 6 months
Number of cumulative voluntary drug intoxications throughout the 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2016.
- Background: PubMed 15128388Alonso J, Angermeyer MC, Bernert S, Bruffaerts R, Brugha TS, Bryson H, de Girolamo G, Graaf R, Demyttenaere K, Gasquet I, Haro JM, Katz SJ, Kessler RC, Kovess V, Lepine JP, Ormel J, Polidori G, Russo LJ, Vilagut G, Almansa J, Arbabzadeh-Bouchez S, Autonell J, Bernal M, Buist-Bouwman MA, Codony M, Domingo-Salvany A, Ferrer M, Joo SS, Martinez-Alonso M, Matschinger H, Mazzi F, Morgan Z, Morosini P, Palacin C, Romera B, Taub N, Vollebergh WA; ESEMeD/MHEDEA 2000 Investigators, European Study of the Epidemiology of Mental Disorders (ESEMeD) Project. Psychotropic drug utilization in Europe: results from the European Study of the Epidemiology of Mental Disorders (ESEMeD) project. Acta Psychiatr Scand Suppl. 2004;(420):55-64. doi: 10.1111/j.1600-0047.2004.00331.x.
- BackgroundAouba, A., Péquignot, F., Camelin, L., Laurent, F., Jougla, E. La mortalité par suicide en France en 2006. Etudes et résultats. 2009 ; (702) : 1-8.
- BackgroundBeck, F., Guignard, R., Du Roscoät, E., Saïas, T. Tentatives de suicide et pensées suicidaires en France en 2010. Bulletin épidémiologique hebdomadaire. 2011 ; 47-48 : 488-492.
- Background: PubMed 14616420Camidge DR, Wood RJ, Bateman DN. The epidemiology of self-poisoning in the UK. Br J Clin Pharmacol. 2003 Dec;56(6):613-9. doi: 10.1046/j.1365-2125.2003.01910.x.
- Background: PubMed 18055960Carter GL, Clover K, Whyte IM, Dawson AH, D'Este C. Postcards from the EDge: 24-month outcomes of a randomised controlled trial for hospital-treated self-poisoning. Br J Psychiatry. 2007 Dec;191:548-53. doi: 10.1192/bjp.bp.107.038406.
- BackgroundChan-Chee, C., & Jezewski-Serra, D. Hospitalisations pour tentatives de suicide entre 2004 et 2007 en France métropolitaine. Analyse du PMSI-MCO. Bulletin épidémiologique hebdomadaire. 2011 ; 47-48 : 492-496.
- Background: PubMed 20409500Coben JH, Davis SM, Furbee PM, Sikora RD, Tillotson RD, Bossarte RM. Hospitalizations for poisoning by prescription opioids, sedatives, and tranquilizers. Am J Prev Med. 2010 May;38(5):517-24. doi: 10.1016/j.amepre.2010.01.022.
- BackgroundDumesnil, S., Grandfils, N., Le Fur, P., Mizrahi, A. Mizrahi, A. Santé, Soins et protection Sociale en France en 1996. CREDES (en ligne). Novembre 1997, (consulté le 3/4/12).
- Background: PubMed 21861593Fedyszyn IE, Harris MG, Robinson J, Edwards J, Paxton SJ. Characteristics of suicide attempts in young people undergoing treatment for first episode psychosis. Aust N Z J Psychiatry. 2011 Oct;45(10):838-45. doi: 10.3109/00048674.2011.595687. Epub 2011 Aug 23.
- Background: PubMed 20207465Florentine JB, Crane C. Suicide prevention by limiting access to methods: a review of theory and practice. Soc Sci Med. 2010 May;70(10):1626-32. doi: 10.1016/j.socscimed.2010.01.029. Epub 2010 Feb 12.
- BackgroundFournet, N., Caillère, N., Fouillet, A., Caserio-Schönemann, C., Josseran, L. Le système français de surveillance sanitaire des urgences et des décès (Sur-SaUD®). Saint-Maurice : Institut de veille sanitaire : 2011. 12p.
- Background: PubMed 15959446Gasquet I, Negre-Pages L, Fourrier A, Nachbaur G, El-Hasnaoui A, Kovess V, Lepine JP. [Psychotropic drug use and mental psychiatric disorders in France; results of the general population ESEMeD/MHEDEA 2000 epidemiological study]. Encephale. 2005 Mar-Apr;31(2):195-206. doi: 10.1016/s0013-7006(05)82386-3. French.
- Soins et protection Sociale en France en 1996. CREDESLink provided by the sponsor.
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.
Maurice Dematteis, Professor principal investigator
Grenoble Hospital University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly divided delivery and Monthly divided delivery in people with Hospitalized for Voluntary Drug Intoxication, 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 5 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 17 Aug 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maurice Dematteis, Professor (+66236, MDematteis@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the efficacy of an advice with a weekly divided drug delivery, compared to an usual monthly delivery in the prevention of voluntary drug intoxications repeated (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02869724, which also lists 35 linked publications.
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 17 Aug 2016.