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Methadone induction in primary care for opioid dependence: a pragmatic randomized trial (ANRS Methaville).

Carrieri PM, Michel L, Lions C, Cohen J, Vray M, Mora M, Marcellin F, Spire B, Morel A, Roux P, Methaville Study Gro - PLoS ONE (2014)

Bottom Line: In the ITT analysis (n = 155 in PC, 66 in SC), which compared the proportions of street-opioid abstinent participants, 85/155 (55%) and 22/66 (33%) of the participants were classified as street-opioid abstinent at M12 in PC and SC, respectively.Engagement in treatment and satisfaction with the explanations provided by the physician were significantly higher in PC than SC.It is as effective as induction in specialized care in reducing street-opioid use and ensuring engagement and retention in treatment for opioid dependence.

View Article: PubMed Central - PubMed

Affiliation: INSERM UMR912 (SESSTIM), Marseille, France; Aix Marseille Université, UMR_S912, Marseille, France; ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille, France.

ABSTRACT

Objective: Methadone coverage is poor in many countries due in part to methadone induction being possible only in specialized care (SC). This multicenter pragmatic trial compared the effectiveness of methadone treatment between two induction models: primary care (PC) and SC.

Methods: In this study, registered at ClinicalTrials.Gov (NCT00657397), opioid-dependent individuals not on methadone treatment for at least one month or receiving buprenorphine but needing to switch were randomly assigned to start methadone in PC (N = 155) or in SC (N = 66) in 10 sites in France. Visits were scheduled at months M0, M3, M6 and M12. The primary outcome was self-reported abstinence from street-opioids at 12 months (M12) (with an underlying 15% non-inferiority hypothesis for PC). Secondary outcomes were abstinence during follow-up, engagement in treatment (i.e. completing the induction period), retention and satisfaction with the explanations provided by the physician. Primary analysis used intention to treat (ITT). Mixed models and the log-rank test were used to assess the arm effect (PC vs. SC) on the course of abstinence and retention, respectively.

Results: In the ITT analysis (n = 155 in PC, 66 in SC), which compared the proportions of street-opioid abstinent participants, 85/155 (55%) and 22/66 (33%) of the participants were classified as street-opioid abstinent at M12 in PC and SC, respectively. This ITT analysis showed the non-inferiority of PC (21.5 [7.7; 35.3]). Engagement in treatment and satisfaction with the explanations provided by the physician were significantly higher in PC than SC. Retention in methadone and abstinence during follow-up were comparable in both arms (p = 0.47, p = 0.39, respectively).

Conclusions: Under appropriate conditions, methadone induction in primary care is feasible and acceptable to both physicians and patients. It is as effective as induction in specialized care in reducing street-opioid use and ensuring engagement and retention in treatment for opioid dependence.

Trial registration: Number Eudract 2008-001338-28; ClinicalTrials.gov: NCT00657397; International Standard Randomized Controlled Trial Number Register ISRCTN31125511.

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Flow chart of ANRS Methaville trial.
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pone-0112328-g001: Flow chart of ANRS Methaville trial.

Mentions: The primary analysis used intention-to-treat (ITT) (n = 221) and the primary outcome was measured using a validated question [12] about opioid use during the previous month collected by CATI or medical interview (when CATI data was incomplete). The difference between both arms in the proportion of patients reporting abstinence from street-opioids during the previous month at M12 and the related 95% confidence interval (95% CI) were computed. In this ITT analysis all patients who discontinued follow-up before M12 for any reason (i.e. refused to start methadone after randomization or discontinued follow-up for any reason including treatment interruption, lost to follow-up, incarceration etc.) were classified as “failure” i.e. street-opioid users (see Fig. 1).


Methadone induction in primary care for opioid dependence: a pragmatic randomized trial (ANRS Methaville).

Carrieri PM, Michel L, Lions C, Cohen J, Vray M, Mora M, Marcellin F, Spire B, Morel A, Roux P, Methaville Study Gro - PLoS ONE (2014)

Flow chart of ANRS Methaville trial.
© Copyright Policy
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4231094&req=5

pone-0112328-g001: Flow chart of ANRS Methaville trial.
Mentions: The primary analysis used intention-to-treat (ITT) (n = 221) and the primary outcome was measured using a validated question [12] about opioid use during the previous month collected by CATI or medical interview (when CATI data was incomplete). The difference between both arms in the proportion of patients reporting abstinence from street-opioids during the previous month at M12 and the related 95% confidence interval (95% CI) were computed. In this ITT analysis all patients who discontinued follow-up before M12 for any reason (i.e. refused to start methadone after randomization or discontinued follow-up for any reason including treatment interruption, lost to follow-up, incarceration etc.) were classified as “failure” i.e. street-opioid users (see Fig. 1).

Bottom Line: In the ITT analysis (n = 155 in PC, 66 in SC), which compared the proportions of street-opioid abstinent participants, 85/155 (55%) and 22/66 (33%) of the participants were classified as street-opioid abstinent at M12 in PC and SC, respectively.Engagement in treatment and satisfaction with the explanations provided by the physician were significantly higher in PC than SC.It is as effective as induction in specialized care in reducing street-opioid use and ensuring engagement and retention in treatment for opioid dependence.

View Article: PubMed Central - PubMed

Affiliation: INSERM UMR912 (SESSTIM), Marseille, France; Aix Marseille Université, UMR_S912, Marseille, France; ORS PACA, Observatoire Régional de la Santé Provence Alpes Côte d'Azur, Marseille, France.

ABSTRACT

Objective: Methadone coverage is poor in many countries due in part to methadone induction being possible only in specialized care (SC). This multicenter pragmatic trial compared the effectiveness of methadone treatment between two induction models: primary care (PC) and SC.

Methods: In this study, registered at ClinicalTrials.Gov (NCT00657397), opioid-dependent individuals not on methadone treatment for at least one month or receiving buprenorphine but needing to switch were randomly assigned to start methadone in PC (N = 155) or in SC (N = 66) in 10 sites in France. Visits were scheduled at months M0, M3, M6 and M12. The primary outcome was self-reported abstinence from street-opioids at 12 months (M12) (with an underlying 15% non-inferiority hypothesis for PC). Secondary outcomes were abstinence during follow-up, engagement in treatment (i.e. completing the induction period), retention and satisfaction with the explanations provided by the physician. Primary analysis used intention to treat (ITT). Mixed models and the log-rank test were used to assess the arm effect (PC vs. SC) on the course of abstinence and retention, respectively.

Results: In the ITT analysis (n = 155 in PC, 66 in SC), which compared the proportions of street-opioid abstinent participants, 85/155 (55%) and 22/66 (33%) of the participants were classified as street-opioid abstinent at M12 in PC and SC, respectively. This ITT analysis showed the non-inferiority of PC (21.5 [7.7; 35.3]). Engagement in treatment and satisfaction with the explanations provided by the physician were significantly higher in PC than SC. Retention in methadone and abstinence during follow-up were comparable in both arms (p = 0.47, p = 0.39, respectively).

Conclusions: Under appropriate conditions, methadone induction in primary care is feasible and acceptable to both physicians and patients. It is as effective as induction in specialized care in reducing street-opioid use and ensuring engagement and retention in treatment for opioid dependence.

Trial registration: Number Eudract 2008-001338-28; ClinicalTrials.gov: NCT00657397; International Standard Randomized Controlled Trial Number Register ISRCTN31125511.

Show MeSH
Related in: MedlinePlus