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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03509077
Other study ID # RC31/18/0046
Secondary ID 2018-A00905-50
Status Recruiting
Phase
First received
Last updated
Start date June 19, 2018
Est. completion date June 19, 2019

Study information

Verified date April 2019
Source University Hospital, Toulouse
Contact Juliette Salles, MD
Phone 05 34 55 75 24
Email salles.j@chu-toulouse.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Patients over 65 years old who are exposed to alcohol or benzodiazepines will be recruited through the Fragility Assessment and Addictions Prevention Day Hospital, the Addiction Service and the Geriatric Post-Emergency Department. Toulouse University Hospital.

The investigators will study descriptively the frequency of substance use disorder and the frequency of DSM-5 criteria associated with this diagnosis in a population of elderly subjects.


Description:

The hypothesis of this research is that some of the DSM-5 criteria for substance use disorder are more appropriate than others in people over 65 years of age. This study therefore aims to describe the frequency of the DSM-5 criteria for the substance use disorder in a population over 65 years of age and to link it secondarily to the severity of the addiction.

The study is a descriptive study of a population of subjects over 65 years old. It aims to search for addiction criteria in this population by formulating the hypothesis of an addictive vulnerability relating to certain risk factors.

To sensitize the detection of criteria, we chose among older subjects those who are most at risk because they are more exposed to the vulnerability factor relative to this population (physical disability, loss of autonomy, loneliness).


Recruitment information / eligibility

Status Recruiting
Enrollment 120
Est. completion date June 19, 2019
Est. primary completion date June 19, 2019
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria:

- To be over 65

- Have given your non-oral opposition to participate in research

- Mini-Mental State Examination (MMSE) greater than or equal to 24

- Be part of one of the 3 inclusion services of the University Hospital of Toulouse

- For 12 months, have daily consumption of benzodiazepine (at least once a day) and / or have excessive alcohol consumption as recommended by the American Geriatric Society (more than one unit of alcohol per day) ).

Exclusion Criteria:

- Patient refusing to participate in the study

- MMSE less than 24

- Acute decompensation of a psychiatric disorder

- Impossibility to understand or speak French

- Patient under the protection of justice

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France University Hospital Toulouse Toulouse

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary The number of DSM-5 criteria The number of DSM-5 criteria for substance use disorder in the patient assessment.
The number of DSM-5 criteria is a method of problematic substance use leading to clinically significant impairment or impairment characterized by the presence of at least two of the following manifestations over a 12-month period
1 hour
Secondary The Mini-GDS : a screening tool The diagnosis of depression will be made using a screening tool, the Mini-GDS, performed in routine clinical practice as part of the assessment at the day hospital for frailty and addiction prevention.
The Mini-GDS includes 4 items rated at one point depending on the answer. A higher score 1 makes it possible to suspect the existence of a depression.
1 hour
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