NCT04343339

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

April 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 13, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

October 8, 2020

Status Verified

April 1, 2020

Enrollment Period

4 months

First QC Date

April 8, 2020

Last Update Submit

October 6, 2020

Conditions

Keywords

Risk of overdose on de-confinmentCOVID-19 containment will change drugs practicesCOVID-19 containment will changes access to careAddiction is a common diseaseAlcoholContainmentDrug use

Outcome Measures

Primary Outcomes (2)

  • 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 (2)

  • health care access

    1 day

  • health care access

    1 month after confinmant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \>18 years
  • Accept study
  • live with an addiction

You may not qualify if:

  • \- not being able to answer the questionnaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Substance-Related DisordersCOVID-19

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Hélène Donnadieu-Rigole, MD PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2020

First Posted

April 13, 2020

Study Start

April 8, 2020

Primary Completion

July 30, 2020

Study Completion

September 30, 2020

Last Updated

October 8, 2020

Record last verified: 2020-04

Locations