AddictionNCT02245685
Longitudinal 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
An observational study of Addiction, run by Nantes University Hospital at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Addiction
- How many people
- 113 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2008to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients under substitution therapy monitored in a specialized care center for addicts
Who may be able to join
- Patients entering a specialized medical care center for addicts
Who cannot join
- Patients refusing to sign the consent for participation
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Addiction
- Keywords
- Substitution Therapy, Specialized Care Center for Addicts
- Medical subject headings
- Behavior, Addictive
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the severity score to heroin addiction (TMSP score)
Measured: 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
Measured: 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)
Measured: 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
Measured: From the time patients leave the specialized care center to the time they are followed by a general practitioner (up to 5 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startJan 2008
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AddictionStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- French Health Products Safety Agency
- Responsible party
- Sponsor
- Investigators
- Pascale JOLLIET, MD, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02245685
- Sponsor's protocol ID
- BRD/07/07-M
- Status last verified
- Jul 2017
- First submitted
- 15 Sep 2014
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 34071908
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal 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
- ClinicalTrials.gov ID
- NCT02245685
- Acronym / sponsor ID
- BRD/07/07-M
- Conditions
- Addiction
- Keywords
- Substitution Therapy, Specialized Care Center for Addicts
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- French Health Products Safety Agency
- Study start
- Jan 2008
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 19 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients under substitution therapy monitored in a specialized care center for addicts
Key inclusion criteria (1 listed)
- Patients entering a specialized medical care center for addicts
Key exclusion criteria (1 listed)
- Patients refusing to sign the consent for participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evolution of the severity score to heroin addiction (TMSP score)
Time frame: 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)
3 secondary outcomes
Evolution of the score of quality of life scale
Time frame: 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)
Time frame: 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
Time frame: From the time patients leave the specialized care center to the time they are followed by a general practitioner (up to 5 years)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2017.
- Derived from this study: PubMed 34071908Guillou-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pascale JOLLIET, MD principal investigator
Nantes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Addiction, run by Nantes University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evolution of the severity score to heroin addiction (TMSP score) (time frame: 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02245685, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2017.