NCT02345655

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

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

First Submitted

Initial submission to the registry

May 14, 2014

Completed
9 months until next milestone

First Posted

Study publicly available on registry

January 26, 2015

Completed
1.2 years until next milestone

Study Start

First participant enrolled

April 11, 2016

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

4.6 years

First QC Date

May 14, 2014

Last Update Submit

February 26, 2026

Conditions

Opiate Addiction

Keywords

Substances consumptionOpiateFamily practice

Outcome Measures

Primary Outcomes (1)

  • 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.

    6 months

Secondary Outcomes (3)

  • Acceptability of OS-UDT (One-site Urine Drug Testing) by patients and GPs

    6 months

  • Patient's adherence to buprenorphine (duration and dose)

    6 months

  • Associated consumptions (decrease in using psychoactive substances)

    6 months

Study Arms (2)

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.

Procedure: urine drug testing

No test

OTHER

Patients will not have to performed the OS-UDT test

Other: no test

Interventions

urine drug testingPROCEDURE

Performed a OS-UDT test in general practice on patients starting buprenorphine

Urine Drug Testing
no testOTHER

normal procedure decided by the general practitioner

No test

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Clermont-Ferrand Hospital

Clermont-Ferrand, France

Location

Grenoble Lyon Hospital

Grenoble, France

Location

Marseille Hospital

Marseille, France

Location

Nancy Hospital

Nancy, France

Location

Service de Pharmacologie Médicale et Clinique - Centre d'addictovigilance - CHU de Toulouse

Toulouse, 31059, France

Location

Related Publications (2)

  • 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. 2025 Jul 25:S0040-5957(25)00105-2. doi: 10.1016/j.therap.2025.07.003. Online ahead of print.

    PMID: 40841272RESULT

  • ESUB-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.

    PMID: 26931763DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Maryse LAPEYRE-MESTRE, MD

    University Hospital of Toulouse

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2014

First Posted

January 26, 2015

Study Start

April 11, 2016

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(5)