NCT04380714

Brief Summary

The SARS-CoV 2 pandemic started in China in December 2019, then reached France on January 24, 2020. On March 14, France moved into phase 3 of the epidemic threshold with the implementation of containment measures on March 17 Measures were put in place by N.Belloubet (French Minister of Justice) from March 17, including suspension of visiting rooms and activities in detention. Containment provides boredom and isolation with many potential consequences: sleep disturbance, anxiety, PTSD, depression, suicide, addictive behavior and violence. However,prisoners have a higher prevalence of substance use disorders than the general population. What will have been the impact of the confinement on the consumption of psychoactive substances by prisoners at the Villeneuve Les Maguelone prison.

  • Anonymous questionnaire from the start
  • Collection of socio-demographic data
  • Collection of consumption data before and during containment
  • Collection of monitoring data

Trial Health

87
On Track

Trial Health Score

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

Enrollment
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2020

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 8, 2020

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

December 29, 2020

Status Verified

December 1, 2020

Enrollment Period

29 days

First QC Date

May 7, 2020

Last Update Submit

December 28, 2020

Conditions

People IncarceratedCOVID-19

Outcome Measures

Primary Outcomes (1)

  • percentage changes in the consumption of psychoactive substances

    percentage changes in the consumption of psychoactive substances

    1 day

Secondary Outcomes (3)

  • Assessment of the level of stress

    1 day

  • Assessment of depression

    1 day

  • Craving modification evaluation

    1 day

Eligibility Criteria

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

People incarcerated in Villeneuve-Lès-Maguelon prison

You may qualify if:

  • Men incarcerated at Villeneuve Les Maguelone prison
  • On a given date (May 12)
  • Major
  • French speaking
  • non illiterate

You may not qualify if:

  • minors
  • patients refusing
  • non-French speaking
  • illiterate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UH Montpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Aurélie Mieuset, PhD

    University Hospitals of Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2020

First Posted

May 8, 2020

Study Start

May 1, 2020

Primary Completion

May 30, 2020

Study Completion

August 1, 2020

Last Updated

December 29, 2020

Record last verified: 2020-12

Locations

FR(1)