NCT02849574

Brief Summary

To improve the management and risk reduction, it is essential to understand the evolution of the consumption of psychoactive substances, medicated or not in detention; it does not have at present no data on this subject. This work has as main objective to evaluate the development of substance use terms (goods and consumption practices) by the inmates between the period preceding their incarceration and their fifth month in detention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
629

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

6 active sites

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

Study Start

First participant enrolled

January 1, 2015

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 29, 2016

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

Same day

First QC Date

July 27, 2016

Last Update Submit

July 28, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • change in practices of consumption of psychoactive substances between the period prior to incarceration and detention period

    composite endpoint representing the existence of a change in practices of consumption of psychoactive substances between the period prior to incarceration and detention period

    Until 5 months

Eligibility Criteria

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

The eligible study population is incarcerated major subjects. The topics will be selected subjects incarcerated in remand centers participating in the study. All subjects were medical examination, Home Maintenance arriving at their entrance into custody. On this occasion, the medical staff will verify the absence of non inclusion criterion and the subject will be informed orally and via an information sheet that will retain an invitation to respond to an anonymous questionnaire will be sent after him 4 or 5 months of detention (as prisons). He may accept or reject this invitation.

You may qualify if:

  • Major subject
  • Subject in the fourth or fifth month of incarceration
  • Held about agreeing to participate in the study

You may not qualify if:

  • Patient refusing to participate
  • Patient unable to respond to the questionnaire (major difficulties understanding of the French language)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Angers University Hospital

Angers, 49000, France

Location

Fontenay Le Comte Hospital

Fontenay-le-Comte, 85200, France

Location

La Roche sur Yon Hospital

La Roche-sur-Yon, 85000, France

Location

Laval Hospital

Laval, 53000, France

Location

Le Mans Hospital

Le Mans, 72000, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Caroline VICTORRI-VIGNEAU, Dr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 27, 2016

First Posted

July 29, 2016

Study Start

January 1, 2015

Primary Completion

January 1, 2015

Study Completion

July 1, 2016

Last Updated

July 29, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share

Locations