Clinical trial NCT00657397: Initialization of Methadone in Primary Care, Randomized Intervention Research for Preventing HCV Transmission Practices
Official title: Initialization of Methadone in Primary Care; a Randomized Intervention Research for Preventing HCV Transmission Practices. ANRS Methaville
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hepatitis C
Substance Dependence
Methadone
Keywords: Methadone
Substance Dependence
Lead sponsor: ANRS, Emerging Infectious Diseases
Sponsor class: OTHER_GOV
First posted: 2008-04-14
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The rapid scale up of opioid substitution treatment (OST) for drug users mainly achieved through the possibility of prescribing buprenorphine in primary care has been successful in reducing HIV prevalence among drug users but still inadequate for reducing the spread of HCV. To date, methadone in France can only be initialised in drug centres but GPs can prescribe methadone after stabilisation of dosages.

This study was born as an answer to a request from the French Minister of Health that supports the initialisation of methadone in primary care in order to improve coverage by OST (now 70%) in drug users.

Detailed description: We aimed to test the non inferiority of the proportion of non users of street-opioids after one year of treatment in patients inducted in primary care (PC) vs.those inducted in a specialised center for substance dependence (CSAPA).

In this multisite, open-label, randomised controlled non-inferiority trial, opioid dependent individuals were randomized to start methadone either in PC or in a CSAPA. After stabilization of methadone dosage (\~2 weeks), patients could change arm. Follow-up assessments through medical questionnaires and phone interviews was scheduled at month 0 (M0, enrolment) M3, M6, M12. The opiate treatment index (OTI) was used for computing the proportion of patients reporting no use of street opioids in the last month at M12 (primary outcome) in those inducted in PC or in a CSAPA and the non inferiority margins.

Primary analysis was by intention to treat (ITT)

Eligibility criteria: Inclusion Criteria:

* 18 to 70 years patients needing methadone for their opioid dependence who are either naives of methadone treatment (prescribed) since at least 1 month
* need to switch from buprenorphine to methadone treatment
* negative test for pregnancy

Exclusion Criteria:

* co-dependent on alcohol and benzodiazepines,
* inmates,
* pregnant women,
* individual in irregular situation or who cannot be joined by phone.

Primary outcomes:
measure: prevalence of non-users of street opioid after one year of treatment will be compared between arms.
timeFrame: one year
Secondary outcomes:
measure: Prevalence of non users of street opioids after three months of treatment
timeFrame: three months
measure: Retention in treatment
timeFrame: one year
measure: Decrease in HCV risk behaviors, addictive behaviors, improvement in quality of life, psychiatric comorbidities, social insertion, reduction in criminal acts
timeFrame: one year
measure: cost-effectiveness
timeFrame: one year
measure: surveillance of severe adverse events and overdose cases in each arm
timeFrame: Day -7 to Month 12
Other outcomes:
Locations:
city: Boulogne
country: France
facility: CSST Le trait d'union
Study officials:
affiliation: CSST Le trait d'union, 154 rue du vieux pont de Sèvres, 92100 Boulogne, France
name: Alain Morel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ORS PACA - INSERM-IRD UMR912, 23, rue Stanislas Torrents, 13006 Marseille
name: Patrizia Carrieri, PHD
role: STUDY_DIRECTOR
References:
citation: Carrieri P, Vilotitch A, Nordmann S, Lions C, Michel L, Mora M, Morel A, Maradan G, Spire B, Roux P; Methaville Study Group. Decrease in self-reported offences and incarceration rates during methadone treatment: A comparison between patients switching from buprenorphine to methadone and maintenance treatment incident users (ANRS-Methaville trial). Int J Drug Policy. 2017 Jan;39:86-91. doi: 10.1016/j.drugpo.2016.08.005. Epub 2016 Oct 19.
citation: Roux P, Lions C, Vilotitch A, Michel L, Mora M, Maradan G, Marcellin F, Spire B, Morel A, Carrieri PM; ANRS Methaville study group. Correlates of cocaine use during methadone treatment: implications for screening and clinical management (ANRS Methaville study). Harm Reduct J. 2016 Apr 5;13:12. doi: 10.1186/s12954-016-0100-7.
citation: Carrieri PM, Michel L, Lions C, Cohen J, Vray M, Mora M, Marcellin F, Spire B, Morel A, Roux P; Methaville Study Group. Methadone induction in primary care for opioid dependence: a pragmatic randomized trial (ANRS Methaville). PLoS One. 2014 Nov 13;9(11):e112328. doi: 10.1371/journal.pone.0112328. eCollection 2014.
citation: Roux P, Lions C, Michel L, Mora M, Daulouede JP, Marcellin F, Spire B, Morel A, Carrieri PM; ANRS Methaville study group. Factors associated with HCV risk practices in methadone-maintained patients: the importance of considering the couple in prevention interventions. Subst Abuse Treat Prev Policy. 2014 Sep 10;9:37. doi: 10.1186/1747-597X-9-37.
citation: Lions C, Carrieri MP, Michel L, Mora M, Marcellin F, Morel A, Spire B, Roux P; Methaville Study Group. Predictors of non-prescribed opioid use after one year of methadone treatment: an attributable-risk approach (ANRS-Methaville trial). Drug Alcohol Depend. 2014 Feb 1;135:1-8. doi: 10.1016/j.drugalcdep.2013.10.018. Epub 2013 Oct 31.
citation: Roux P, Michel L, Cohen J, Mora M, Morel A, Aubertin JF, Desenclos JC, Spire B, Carrieri PM; ANRS Methaville Study Group. Methadone induction in primary care (ANRS-Methaville): a phase III randomized intervention trial. BMC Public Health. 2012 Jun 28;12:488. doi: 10.1186/1471-2458-12-488.