Opiate AddictionESUB-MGNCT02345655
On-site Evaluation of Substances Consumption on Opiate Maintenance
A study testing urine drug testing and no test in people with Opiate Addiction, run by University Hospital, Toulouse at 5 sites in France.
Trial summary
In France, General Practitioners (GPs) are widely involved in opiate maintenance treatment (OMT) by initially prescribing buprenorphine and monitoring patients under buprenorphine and methadone. Number of treated patients is around 150,000 with 75% of them treated by buprenorphine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opiate Addiction
- What is being tested?
- urine drug testing and no test
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 5 sitesFrance
- Study dates
- 11 Apr 2016to Dec 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For GPs:Professional criteria: to practice as a GP, to be in activity, to practice in general ambulatory practice (in a medical office), to regularly manage patients treated with buprenorphine, to be registered in sector 1, consent for participating to the study
- For patients:
- Aged 18 years-old or more, to consult for starting buprenorphine or OMT:
- any patient previously treated by buprenorphine or buprenorphine-naloxone but with his/her treatment interrupted for at least 2 months will be considered as a candidate for a new treatment with buprenorphine or buprenorphine-naloxone
- any patient previously exposed to opiate maintenance drug obtained illegally "in the street" will not be as treated affiliated to a health insurance scheme, not opposed to participate
Who cannot join
- For patients: to consult for continuing buprenorphine or for another complain related, to opiate substitution treatment, to be known and yet managed by the GP for an opiate substitutive treatment, to have started buprenorphine in a specialized centre or in a hospital, to be treated with methadone, to be treated with methadone and asking a switch toward buprenorphine
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Clermont-Ferrand Hospital
Clermont-Ferrand
Grenoble Lyon Hospital
Grenoble
Marseille Hospital
Marseille
Nancy Hospital
Nancy
Service de Pharmacologie Médicale et Clinique - Centre d'addictovigilance - CHU de Toulouse
Toulouse, 31059
About this study
Official title: Impact of On-site Evaluation of Substances Consumption on Opiate Maintenance in the Context of Family Practice
In France, General Practitioners (GPs) are widely involved in opiate maintenance treatment (OMT) by initially prescribing buprenorphine and monitoring patients under buprenorphine and methadone. Number of treated patients is around 150,000 with 75% of them treated by buprenorphine. Among the guidelines for improving OMT, urine testing is mandatory for initiating methadone, whereas it is recommended for initiating buprenorphine and during follow-up. Urine drug tests are based on immunoassay techniques and enable a qualitative analysis of the recent drug consumption, with detection based on designated thresholds, allow a better appraisal of drug exposure, before initiating and during OMT. While intrinsic diagnostic value of these tests is already demonstrated, the consequences of carrying out these tests on OMT have not been clearly established. Some studies suggest that patients exposed to drug tests may have a better OMT retention and in patients treated by methadone, performing urine screening tests has been shown to be associated with a mortality risk reduction in a Scottish retrospective cohort of opioid addicts. Actually, despite the recommendations to perform these tests, few GP prescribe tests, and few patients are regularly screened. Availability of commercial kits for urine drug testing in the medical office should improve their utilisation.
The widespread of urine drug screening tests use in ambulatory care is a reality for some GPs working in addictology networks. Despite a global benefit reported in the literature with a better control in prescribing OMT and a better patients' adherence, as far as the investigators know, no study has yet explored the impact of the use of urine drug screening test in decision making in general practice with an intervention study.
Read the detailed description
In a retrospective cohort study of methadone users performed through data obtained from a primary care prescription registry in Tayside, Scotland, McCowan et al examined the interaction of patient related factors and prescribing factors at the individual level and assess their independent impact on the risk of both all-cause mortality and drug dependent cause specific mortality (McCowan, Kidd et al. 2009). Overall, 181 (8%) people died among 2378 subjects with a median follow-up of 4.38 years. Overuse of methadone, history of psychiatric admission, and increasing comorbidity were all associated with an increase in all-cause mortality. Longer duration of use (adjusted hazard ratio 0.95, 0.94 to 0.96), history of having urine tested (0.33, 0.22 to 0.49), and increasing time since last filled prescription were protective in relation to all-cause mortality. These factors are likely to be markers of people who are stabilised on maintenance treatment and engaged in monitoring procedures or who have successfully completed a methadone treatment reduction programme. This community based study gives a clear indication of the prescribing, monitoring, and management of patients in OMT and the subsequent impact on all cause and drug dependent mortality. This study provides evidence that recommendations on best practice (including specifically performing UDS) improve patients' outcomes.
Using data from the French "Methaville" trial, Roux et al (Roux, Michel et al. 2012; Roux, Lions et al. 2013) investigated the effect of pre-treatment and in-treatment factors on long-term non-adherence to this OMT. Four pre-treatment predictors of non-adherence were identified: being female, not having stable housing, alcohol consumption and cocaine use. These findings highlight the need to appropriately assess psychoactive drug use when starting OMT, and urine drug testing should be consider as a way to reach this aim.
On the basis of the literature, one would suppose that carrying out UDS would provide an improvement in the management of patients with abuse or addiction and would be helpful, particularly in community office-based settings, as office-based management of opioid dependence grows up (Walley, Alperen et al. 2008). Despite the lack of significant evidence of efficacy, UDS are recommended to assess the use of psychoactive substances when abuse or addiction is suspected.
- Conditions
- Opiate Addiction
- Being tested
- urine drug testing, no test
- Keywords
- Substances consumption, Opiate, Family practice
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
urine drug testingProcedure or surgery
Performed a OS-UDT test in general practice on patients starting buprenorphine
no testOther
normal procedure decided by the general practitioner
| Study group | Role | What they receive |
|---|---|---|
| Urine Drug Testing | Experimental | GPs of the intervention group will dedicate an average 5 minutes during the consult to perform OS-UDT. Patients will be asked to collect a urine sample at the GP's medical office. GP will read and communicate the results immediately to the patients. GPs will keep free of their management according to OS-UDT results. Receives: Procedure: urine drug testing |
| No test | Other | Patients will not have to performed the OS-UDT test Receives: Other: no test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of on-site urine drug screening tests
The main objective will be to assess the impact of on-site urine drug screening tests in general practice compared to routine medical care on OMT retention at six months in opioid-dependent patients initiating buprenorphine.
Measured: 6 months
Secondary outcomes (3)
Acceptability of OS-UDT (One-site Urine Drug Testing) by patients and GPs
To assess if patients and GPs accept to performed the One-Site Urine Drug Testing
Measured: 6 months
Patient's adherence to buprenorphine (duration and dose)
General Practitioner will assessed if patients follow their treatments (duration and dose)
Measured: 6 months
Associated consumptions (decrease in using psychoactive substances)
GP will assessed and characterized other medical products taken in association with the treatment studied.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study start11 Apr 2016
- Primary completionDec 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Opiate AddictionStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maryse LAPEYRE-MESTRE, MD, Principal investigator, University Hospital of Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02345655
- Sponsor's protocol ID
- RC31/13/7049
- Other IDs
- 2014-A00393-44
- Acronym
- ESUB-MG
- Status last verified
- Feb 2026
- First submitted
- 14 May 2014
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dupouy J, Rousseau V, Authier N, Di Patrizio P, Gentile G, Gibaja V, Laporte C, Letrilliart L, Maynie C, Micallef J, Mallaret M, Oustric S, Berard E, Lapeyre-Mestre M. Impact of urine drug screening on opioid agonist treatment maintenance with buprenorphine in primary care in France: A cluster-randomized trial. Therapie. 2026 May-Jun;81(3):212-223. doi: 10.1016/j.therap.2025.07.003. Epub 2025 Jul 25.
PubMed 40841272ESUB-MG Study Group. Study protocol of the ESUB-MG cluster randomized trial: a pragmatic trial assessing the implementation of urine drug screening in general practice for buprenorphine maintained patients. BMC Fam Pract. 2016 Mar 1;17:24. doi: 10.1186/s12875-016-0413-3.
PubMed 26931763
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of On-site Evaluation of Substances Consumption on Opiate Maintenance in the Context of Family Practice
- ClinicalTrials.gov ID
- NCT02345655
- Acronym / sponsor ID
- ESUB-MG / RC31/13/7049
- Conditions
- Opiate Addiction
- Keywords
- Substances consumption, Opiate, Family practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 11 Apr 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 26 Jan 2015 (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.
In France, General Practitioners (GPs) are widely involved in opiate maintenance treatment (OMT) by initially prescribing buprenorphine and monitoring patients under buprenorphine and methadone. Number of treated patients is around 150,000 with 75% of them treated by buprenorphine. Among the guidelines for improving OMT, urine testing is mandatory for initiating methadone, whereas it is recommended for initiating buprenorphine and during follow-up. Urine drug tests are based on immunoassay techniques and enable a qualitative analysis of the recent drug consumption, with detection based on designated thresholds, allow a better appraisal of drug exposure, before initiating and during OMT. While intrinsic diagnostic value of these tests is already demonstrated, the consequences of carrying out these tests on OMT have not been clearly established. Some studies suggest that patients exposed to drug tests may have a better OMT retention and in patients treated by methadone, performing urine screening tests has been shown to be associated with a mortality risk reduction in a Scottish retrospective cohort of opioid addicts. Actually, despite the recommendations to perform these tests, few GP prescribe tests, and few patients are regularly screened. Availability of commercial kits for urine drug testing in the medical office should improve their utilisation.
The widespread of urine drug screening tests use in ambulatory care is a reality for some GPs working in addictology networks. Despite a global benefit reported in the literature with a better control in prescribing OMT and a better patients' adherence, as far as the investigators know, no study has yet explored the impact of the use of urine drug screening test in decision making in general practice with an intervention study.
Detailed description
In a retrospective cohort study of methadone users performed through data obtained from a primary care prescription registry in Tayside, Scotland, McCowan et al examined the interaction of patient related factors and prescribing factors at the individual level and assess their independent impact on the risk of both all-cause mortality and drug dependent cause specific mortality (McCowan, Kidd et al. 2009). Overall, 181 (8%) people died among 2378 subjects with a median follow-up of 4.38 years. Overuse of methadone, history of psychiatric admission, and increasing comorbidity were all associated with an increase in all-cause mortality. Longer duration of use (adjusted hazard ratio 0.95, 0.94 to 0.96), history of having urine tested (0.33, 0.22 to 0.49), and increasing time since last filled prescription were protective in relation to all-cause mortality. These factors are likely to be markers of people who are stabilised on maintenance treatment and engaged in monitoring procedures or who have successfully completed a methadone treatment reduction programme. This community based study gives a clear indication of the prescribing, monitoring, and management of patients in OMT and the subsequent impact on all cause and drug dependent mortality. This study provides evidence that recommendations on best practice (including specifically performing UDS) improve patients' outcomes.
Using data from the French "Methaville" trial, Roux et al (Roux, Michel et al. 2012; Roux, Lions et al. 2013) investigated the effect of pre-treatment and in-treatment factors on long-term non-adherence to this OMT. Four pre-treatment predictors of non-adherence were identified: being female, not having stable housing, alcohol consumption and cocaine use. These findings highlight the need to appropriately assess psychoactive drug use when starting OMT, and urine drug testing should be consider as a way to reach this aim.
On the basis of the literature, one would suppose that carrying out UDS would provide an improvement in the management of patients with abuse or addiction and would be helpful, particularly in community office-based settings, as office-based management of opioid dependence grows up (Walley, Alperen et al. 2008). Despite the lack of significant evidence of efficacy, UDS are recommended to assess the use of psychoactive substances when abuse or addiction is suspected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Urine Drug Testing | Experimental | Procedure: urine drug testingGPs of the intervention group will dedicate an average 5 minutes during the consult to perform OS-UDT. Patients will be asked to collect a urine sample at the GP's medical office. GP will read and communicate the results immediately to the patients. GPs will keep free of their management according to OS-UDT results. |
| No test | Other | Other: no testPatients will not have to performed the OS-UDT test |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- For GPs:Professional criteria: to practice as a GP, to be in activity, to practice in general ambulatory practice (in a medical office), to regularly manage patients treated with buprenorphine, to be registered in sector 1, consent for participating to the study
- For patients:
- any patient previously treated by buprenorphine or buprenorphine-naloxone but with his/her treatment interrupted for at least 2 months will be considered as a candidate for a new treatment with buprenorphine or buprenorphine-naloxone
- any patient previously exposed to opiate maintenance drug obtained illegally "in the street" will not be as treated affiliated to a health insurance scheme, not opposed to participate
Key exclusion criteria (1 listed)
- For patients: to consult for continuing buprenorphine or for another complain related, to opiate substitution treatment, to be known and yet managed by the GP for an opiate substitutive treatment, to have started buprenorphine in a specialized centre or in a hospital, to be treated with methadone, to be treated with methadone and asking a switch toward buprenorphine
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| urine drug testingPerformed a OS-UDT test in general practice on patients starting buprenorphine | Procedure or surgery | Urine Drug Testing |
| no testnormal procedure decided by the general practitioner | Other | No test |
Primary outcome
Impact of on-site urine drug screening tests
Time frame: 6 months
The main objective will be to assess the impact of on-site urine drug screening tests in general practice compared to routine medical care on OMT retention at six months in opioid-dependent patients initiating buprenorphine.
3 secondary outcomes
Acceptability of OS-UDT (One-site Urine Drug Testing) by patients and GPs
Time frame: 6 months
Patient's adherence to buprenorphine (duration and dose)
Time frame: 6 months
Associated consumptions (decrease in using psychoactive substances)
Time frame: 6 months
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 2 Mar 2026.
- Results publication: PubMed 40841272Dupouy J, Rousseau V, Authier N, Di Patrizio P, Gentile G, Gibaja V, Laporte C, Letrilliart L, Maynie C, Micallef J, Mallaret M, Oustric S, Berard E, Lapeyre-Mestre M. Impact of urine drug screening on opioid agonist treatment maintenance with buprenorphine in primary care in France: A cluster-randomized trial. Therapie. 2026 May-Jun;81(3):212-223. doi: 10.1016/j.therap.2025.07.003. Epub 2025 Jul 25.
- Derived from this study: PubMed 26931763ESUB-MG Study Group. Study protocol of the ESUB-MG cluster randomized trial: a pragmatic trial assessing the implementation of urine drug screening in general practice for buprenorphine maintained patients. BMC Fam Pract. 2016 Mar 1;17:24. doi: 10.1186/s12875-016-0413-3.
- Individual participant dataSharing planned: No
Related trials for Opiate Addiction
RecruitingPhase 2
Infusion of Lidocaine and Steroids in Middle Meningeal Artery for Pain in Subarachnoid Hemorrhage
Subarachnoid Hemorrhage, Aneurysmal, Headache
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Active, not recruiting
The MOUD Plus Pilot: Counseling and Peer Support to Support Retention for Medically Complex Patients With Opioid Use Disorder Seen In Primary Care
Opioid Dependence, Substance Abuse Disorders
RecruitingPhase 1
MethaLoad Dose-Finding Study
Opioid Use Disorder (OUD)
Not yet recruitingPhase 1/2
Medically Supervised Ibogaine With 12-Month Digital Recovery Support for Opioid Use Disorder
Opioid Use Disorder, Opioid Withdrawal
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.
Maryse LAPEYRE-MESTRE, MD principal investigator
University Hospital of Toulouse
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing urine drug testing and no test in people with Opiate Addiction, run by University Hospital, Toulouse at 5 sites 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 5 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 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Impact of on-site urine drug screening tests (time frame: 6 months). 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 NCT02345655, which also lists 2 linked publications.
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 2 Mar 2026.