Initialization of Methadone in Primary Care, Randomized Intervention Research for Preventing HCV Transmission Practices - Full Text View

Sponsored by:	French National Agency for Research on AIDS and Viral Hepatitis
Information provided by:	French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:	NCT00657397

Purpose

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 Intravenous drug users.

Condition	Intervention	Phase
Hepatitis C Substance Dependence Methadone	Drug: Methadone	Phase III

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Methadone Methadone hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Initialization of Methadone in Primary Care; a Randomized Intervention Research for Preventing HCV Transmission Practices. ANRS Methaville

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:

prevalence of daily injectors after one year of treatment will be compared between arms. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

- prevalence of other addictive behaviours [ Time Frame: one year ] [ Designated as safety issue: No ]
adherence to treatment [ Time Frame: one year ] [ Designated as safety issue: No ]
improvement in quality of life, psychiatric comorbidities, social insertion, reduction in criminal acts [ Time Frame: one year ] [ Designated as safety issue: No ]
cost-effectiveness [ Time Frame: one year ] [ Designated as safety issue: No ]
surveillance of severe adverse events and overdose cases in each arm [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Methadone prescribed by general physician	Drug: Methadone
B: Active Comparator Methadone prescribed in centres for the treatment of drugs dependence (CSST)	Drug: Methadone

Detailed Description:

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 Intravenous drug users.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00657397

Locations

France
CSST Le trait d'union
Boulogne, France, 92100

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

Investigators

Principal Investigator:	Alain Morel, MD	CSST Le trait d'union, 154 rue du vieux pont de Sèvres, 92100 Boulogne, France
Study Director:	Patrizia Carrieri, PHD	ORS PACA - INSERM-IRD UMR912, 23, rue Stanislas Torrents, 13006 Marseille

More Information

Responsible Party:	ANRS ( Christelle Paul regulatory affairs )
Study ID Numbers:	ANRS Methaville
Study First Received:	April 8, 2008
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00657397
Health Authority:	France: Direction Générale de la Santé

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

Methadone
Substance Dependence

Study placed in the following topic categories:

Liver Diseases
Hepatitis, Viral, Human
Disorders of Environmental Origin
Hepatitis
Virus Diseases
Naphazoline
Methadone
Oxymetazoline

Digestive System Diseases
Guaifenesin
Mental Disorders
Phenylephrine
Substance-Related Disorders
Phenylpropanolamine
Hepatitis C

Additional relevant MeSH terms:

Respiratory System Agents
RNA Virus Infections
Flaviviridae Infections
Physiological Effects of Drugs
Central Nervous System Depressants
Narcotics
Pharmacologic Actions

Sensory System Agents
Therapeutic Uses
Analgesics
Peripheral Nervous System Agents
Antitussive Agents
Central Nervous System Agents
Analgesics, Opioid

ClinicalTrials.gov processed this record on January 16, 2009