Hepatitis CPhase 3MethavilleNCT00657397
Initialization of Methadone in Primary Care, Randomized Intervention Research for Preventing HCV Transmission Practices
A Phase 3 study testing Methadone in people with Hepatitis C and Substance Dependence, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hepatitis C, Substance Dependence, Methadone
- What is being tested?
- Methadone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 197 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Dec 2011
- Phase
- Phase 3
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- co-dependent on alcohol and benzodiazepines,
- inmates,
- pregnant women,
- individual in irregular situation or who cannot be joined by phone.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Initialization of Methadone in Primary Care; a Randomized Intervention Research for Preventing HCV Transmission Practices. ANRS Methaville
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.
Read the 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)
- Conditions
- Hepatitis C, Substance Dependence, Methadone
- Being tested
- Methadone
- Keywords
- Methadone, Substance Dependence
- Medical subject headings
- Hepatitis C, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
Methadone sirup once daily
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Methadone inducted by a primary care physician Receives: Drug: Methadone |
| B | Active comparator | Methadone inducted (in CSAPA) Receives: Drug: Methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of non-users of street opioid after one year of treatment will be compared between arms.
Measured: one year
Secondary outcomes (5)
Prevalence of non users of street opioids after three months of treatment
Measured: three months
Retention in treatment
Measured: one year
Decrease in HCV risk behaviors, addictive behaviors, improvement in quality of life, psychiatric comorbidities, social insertion, reduction in criminal acts
Measured: one year
cost-effectiveness
Measured: one year
surveillance of severe adverse events and overdose cases in each arm
Measured: Day -7 to Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- French National Agency for Research on AIDS and Viral Hepatitis
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Alain Morel, MD, Principal investigator, CSST Le trait d'union, 154 rue du vieux pont de Sèvres, 92100 Boulogne, FrancePatrizia Carrieri, PHD, Study director, ORS PACA - INSERM-IRD UMR912, 23, rue Stanislas Torrents, 13006 Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00657397
- Sponsor's protocol ID
- ANRS Methaville
- Acronym
- Methaville
- Status last verified
- Jul 2012
- First submitted
- 8 Apr 2008
- Last updated
- 24 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Perry D, Kirkwood JE, Doroshuk ML, Kelmer M, Korownyk CS, Ton J, Garrison SR. Opioid agonist therapy for opioid use disorder in primary versus specialty care. Cochrane Database Syst Rev. 2025 Sep 8;9(9):CD013672. doi: 10.1002/14651858.CD013672.pub2.
PubMed 40919724Carrieri 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.
PubMed 27770695Roux 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.
PubMed 27048152Carrieri 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.
PubMed 25393311Roux 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.
PubMed 25209306Lions 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.
PubMed 24268548Roux 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.
PubMed 22741944
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initialization of Methadone in Primary Care; a Randomized Intervention Research for Preventing HCV Transmission Practices. ANRS Methaville
- ClinicalTrials.gov ID
- NCT00657397
- Acronym / sponsor ID
- Methaville / ANRS Methaville
- Conditions
- Hepatitis C, Substance Dependence, Methadone
- Keywords
- Methadone, Substance Dependence
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- French National Agency for Research on AIDS and Viral HepatitisOther government
- Study start
- Jan 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 14 Apr 2008 (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.
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: MethadoneMethadone inducted by a primary care physician |
| B | Active comparator | Drug: MethadoneMethadone inducted (in CSAPA) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- co-dependent on alcohol and benzodiazepines,
- inmates,
- pregnant women,
- individual in irregular situation or who cannot be joined by phone.
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 |
|---|---|---|
| MethadoneMethadone sirup once daily | Drug | A, B |
Primary outcome
prevalence of non-users of street opioid after one year of treatment will be compared between arms.
Time frame: one year
5 secondary outcomes
Prevalence of non users of street opioids after three months of treatment
Time frame: three months
Retention in treatment
Time frame: one year
Decrease in HCV risk behaviors, addictive behaviors, improvement in quality of life, psychiatric comorbidities, social insertion, reduction in criminal acts
Time frame: one year
cost-effectiveness
Time frame: one year
surveillance of severe adverse events and overdose cases in each arm
Time frame: Day -7 to Month 12
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 24 Jul 2012.
- Derived from this study: PubMed 40919724Perry D, Kirkwood JE, Doroshuk ML, Kelmer M, Korownyk CS, Ton J, Garrison SR. Opioid agonist therapy for opioid use disorder in primary versus specialty care. Cochrane Database Syst Rev. 2025 Sep 8;9(9):CD013672. doi: 10.1002/14651858.CD013672.pub2.
- Derived from this study: PubMed 27770695Carrieri 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.
- Derived from this study: PubMed 27048152Roux 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.
- Derived from this study: PubMed 25393311Carrieri 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.
- Derived from this study: PubMed 25209306Roux 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.
- Derived from this study: PubMed 24268548Lions 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.
- Derived from this study: PubMed 22741944Roux 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.
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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.
Alain Morel, MD principal investigator
CSST Le trait d'union, 154 rue du vieux pont de Sèvres, 92100 Boulogne, France
Patrizia Carrieri, PHD study director
ORS PACA - INSERM-IRD UMR912, 23, rue Stanislas Torrents, 13006 Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methadone in people with Hepatitis C and Substance Dependence, run by French National Agency for Research on AIDS and Viral Hepatitis at 1 site 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 3 inclusion and 4 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 24 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
prevalence of non-users of street opioid after one year of treatment will be compared between arms. (time frame: one year). 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 NCT00657397, which also lists 7 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 24 Jul 2012.