Evolution of Psychoactive Substances Consumption in Conne... | NCT04343339

Studies
Evolution of Psychoactive Substances Consumption in Connection With COVID-19 Containment

NCT04343339

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Oct 8, 2020Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Addiction, Substance
COVID-19

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

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 8, 2020Actual

Primary Completion Date

Jul 30, 2020Actual

Completion Date

Sep 30, 2020Actual

First Submitted Date

Apr 8, 2020

First Submission Date that Met QC Criteria

Apr 8, 2020

First Posted Date

Apr 13, 2020Actual

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

Oct 6, 2020

Last Update Posted Date

Oct 8, 2020Actual

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

The current containment linked to COVID-19 will have consequences for people suffering from addiction and there is a risk of overdoses when the containment ends. So the investigators hypothesize that this health crisis is an opportunity to develop risk reduction and access to care for vulnerable people who lives with an addiction.

The main objective of this study is to describe the changes in the psychoactive substances consumption during the containment in people suffering from addiction. The secondary objectives are to describe the evolution at 1 month from the end of the containment of problematic consumption and the level of access to care of these users

Detailed Description

Not provided

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

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Evolution of consumption	measurement of the difference in drugs consumption caused by containment (delta)	1 day
Evolution of consumption	measurement of the difference in drugs consumption caused by containment (delta)	1 month after confinmant

Secondary Outcomes

Measure	Description	Time Frame
health care access	number of drug users referred to care (%)	1 day
health care access	number of drug users referred to care (%)	1 month after confinmant

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

>18 years
Accept study
live with an addiction

Exclusion criteria:

- not being able to answer the questionnaire

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Person who lives with an addiction accepting the principle of the study

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hélène Donnadieu-Rigole, MD PhD	University Hospital, Montpellier	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019966	Substance-Related Disorders
D000086382	COVID-19

Ancestor Terms

ID	Term
D064419	Chemically-Induced Disorders
D001523	Mental Disorders
D011024	Pneumonia, Viral
D011014	Pneumonia

Browse Leaves

Not provided

Browse Branches

Not provided