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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04380714
Other study ID # RECHMPL20_0273
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 2020
Est. completion date August 1, 2020

Study information

Verified date December 2020
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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


Recruitment information / eligibility

Status Completed
Enrollment 700
Est. completion date August 1, 2020
Est. primary completion date May 30, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria: - Men incarcerated at Villeneuve Les Maguelone prison - On a given date (May 12) - Major - French speaking - non illiterate Exclusion criteria: - minors - patients refusing - non-French speaking - illiterate

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France UH Montpellier Montpellier

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary percentage changes in the consumption of psychoactive substances percentage changes in the consumption of psychoactive substances 1 day
Secondary Assessment of the level of stress Assessment of the level of stress by self-administered questionnaire before / during confinement 1 day
Secondary Assessment of depression Assessment of depression by self-administered questionnaire before / during confinement 1 day
Secondary Craving modification evaluation Craving modification evaluation 1 day
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