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On-site Evaluation of Substances Consumption on Opiate Maintenance (ESUB-MG)

This study is currently recruiting participants.
Verified February 2017 by University Hospital, Toulouse
Sponsor:
ClinicalTrials.gov Identifier:
NCT02345655
First Posted: January 26, 2015
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Toulouse
  Purpose

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.


Condition Intervention
Opiate Addiction Procedure: urine drug testing Other: no test

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Impact of On-site Evaluation of Substances Consumption on Opiate Maintenance in the Context of Family Practice

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Acceptability of OS-UDT (One-site Urine Drug Testing) by patients and GPs [ Time Frame: 6 months ]
    To assess if patients and GPs accept to performed the One-Site Urine Drug Testing

  • Patient's adherence to buprenorphine (duration and dose) [ Time Frame: 6 months ]
    General Practitioner will assessed if patients follow their treatments (duration and dose)

  • Associated consumptions (decrease in using psychoactive substances) [ Time Frame: 6 months ]
    GP will assessed and characterized other medical products taken in association with the treatment studied.


Estimated Enrollment: 400
Study Start Date: January 2016
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Urine Drug Testing
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
Performed a OS-UDT test in general practice on patients starting buprenorphine
No test
Patients will not have to performed the OS-UDT test
Other: no test
normal procedure decided by the general practitioner

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  • 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, affiliated to a health insurance scheme, not opposed to participate

EXCLUSION CRITERIA

  • For GPs: to practice in a group medical office in which another GP has been included in the trial
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345655


Contacts
Contact: Maryse LAPEYRE-MESTRE, MD 05 61 14 59 03 ext +33 maryse.lapeyre-mestre@univ-tlse3.fr
Contact: Maryse LAPEYRE-MESTRE, MD

Locations
France
Service de Pharmacologie Médicale et Clinique - Centre d'addictovigilance - CHU de Toulouse Recruiting
Toulouse, France, 31059
Contact: Maryse LAPEYRE-MESTRE    05 61 14 59 03 ext +33    maryse.lapeyre-mestre@univ-tlse3.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Maryse LAPEYRE-MESTRE, MD University Hospital of Toulouse
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02345655     History of Changes
Other Study ID Numbers: 13 7049 01
First Submitted: May 14, 2014
First Posted: January 26, 2015
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
Substances consumption
Opiate
Family practice

Additional relevant MeSH terms:
Opioid-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Opiate Alkaloids
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents