NCT02245685

Brief Summary

This study is part of the french priorities of the 2007-2011 addiction plan. Priority #2 of the plan underlines the need to improve practices and access to opioid substitution treatment. Priority 3 stresses the importance of articulation and coordination between specialized structures and community medicine to optimize the quality of care and to ensure continuity in the followup of these patients. This study focuses on the followup of patients under substitution therapy from the moment they enter a specialized care center for addicts to the period they are monitored by a general practitioner outside the specialized care center. The assessment described in this study should allow to harmonize and keep a continuity in patient monitoring.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2008

Longer than P75 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

January 1, 2008

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2014

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

6.4 years

First QC Date

September 15, 2014

Last Update Submit

July 18, 2017

Conditions

Keywords

Substitution TherapySpecialized Care Center for Addicts

Outcome Measures

Primary Outcomes (1)

  • Evolution of the severity score to heroin addiction (TMSP score)

    From the time patients start to be followed in the specialized care center to the time they leave the specialized care center (up to 5 years)

Secondary Outcomes (3)

  • Evolution of the score of quality of life scale

    From the time patients start to be followed in the specialized care center to the time they leave the specialized care center (up to 5 years)

  • Evolution of the severity score to heroin addiction (TMSP score)

    From the time patients leave the specialized care center to the time they are followed by a general practitioner (up to 5 years)

  • Evolution of the score of quality of life scale

    From the time patients leave the specialized care center to the time they are followed by a general practitioner (up to 5 years)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients under substitution therapy monitored in a specialized care center for addicts

You may qualify if:

  • Patients entering a specialized medical care center for addicts

You may not qualify if:

  • Patients refusing to sign the consent for participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CSST "La Rose des Vents"

Saint-Nazaire, 44600, France

Location

Related Publications (1)

  • Guillou-Landreat M, Levassor P, Guerlais M, Sebille V, Victorri-Vigneau C. Prospective Study on Factors Associated with Referral of Patients with Opioid Maintenance Therapy from Specialized Addictive Disorders Centers to Primary Care. Int J Environ Res Public Health. 2021 May 27;18(11):5749. doi: 10.3390/ijerph18115749.

MeSH Terms

Conditions

Behavior, Addictive

Condition Hierarchy (Ancestors)

Compulsive BehaviorImpulsive BehaviorBehavior

Study Officials

  • Pascale JOLLIET, MD

    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

September 15, 2014

First Posted

September 19, 2014

Study Start

January 1, 2008

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 19, 2017

Record last verified: 2017-07

Locations