Study of Addiction Criteria in the Elderly | NCT03509077

Studies
Study of Addiction Criteria in the Elderly

NCT03509077

Sponsor

University Hospital, Toulouse

Status

Unknown status

Last Update Posted

Apr 18, 2019Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Depressive Disorder

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2018-A00905-50	Other Identifier	ID-RCB

Status Module

Record Verification Date

Apr 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 19, 2018Actual

Primary Completion Date

Jun 19, 2019Estimated

Completion Date

Jun 19, 2019Estimated

First Submitted Date

Apr 16, 2018

First Submission Date that Met QC Criteria

Apr 16, 2018

First Posted Date

Apr 26, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2019

Last Update Posted Date

Apr 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed 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).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Three groups of patients will be recruited in three departments of the University Hospital of Toulouse:

Patients meeting the criteria for frailty will be recruited to the Fragility Assessment and Addiction Prevention Day Hospital.
Patients over 65, addicts and consultant in a specialized service.
Patients who have decompensated their fragility criteria will be recruited from the geriatric post-emergency department of Toulouse University Hospital.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Juliette Salles, MD	Contact	05 34 55 75 24	33	salles.j@chu-toulouse.fr
Isabelle Olivier, PhD	Contact	05 61 77 70 51	33	olivier.i@chu-toulouse.fr

Overall Officials

Name	Affiliation	Role
Juliette Salles, MD	University Hospital, Toulouse	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Toulouse	Recruiting	Toulouse		31059	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003866	Depressive Disorder
D016739	Behavior, Addictive

Ancestor Terms

ID	Term
D019964	Mood Disorders
D001523	Mental Disorders
D003192	Compulsive Behavior
D007175	Impulsive Behavior

Browse Leaves

Not provided

Browse Branches

Not provided