Observational Study to Assess the Adequacy of Methadone Dosage, in Heroin Addicted Patients in a MMT.

NCT02062736 | Completed

• 1 other identifier: M.E.T.O.D.O.
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of the study ( observational and prospective ) is to evaluate the efficacy and tolerability of the methadone maintenance treatment in patients addicted to heroin. The efficacy and tolerability are assessed by correlating to the adequacy of the dosage of methadone. The patients will be observed for two years.

Conditions

Heroin Addiction

Keywords

methadone; heroin addiction; methadone maintenance treatment; adequate dosage of methadone

Outcome Measures

Primary Outcomes (1)

• the efficacy of the methadone maintenance treatment in addicted heroin patients, evaluating the correlation among efficacy and adequate dosage in comparison to not adequate dosage.

  2 years ( 7 visits for patient )

Secondary Outcomes (3)

• QT prolongation risk in patients addicted to heroin who have undertaken MMT

  2 years ( evaluation at t0, t0 +6/12/18/24 months)

• psychopathological status of observed patients in correlation with the adequate dosage in comparison to not adequate dosages

  2 years ( 7 visits for patient )

• pharmacoeconomic condition correlated with the adequate dosage in comparison to not adequate dosage.

  2 years ( 7 visits for patient )

Study Arms (1)

pts addicted to heroin in MMT

patients addicted to heroin who have undertaken methadone maintenance treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients addicted to heroin and who have undertaken a methadone maintenance treatment, observed in involved centres.

You may qualify if:

• Both sexes
• Over 18 years of age
• Patients with a diagnosis of heroin addiction according to ICD-10 (International Classification of Diseases)
• Patients who have undertaken a methadone maintenance treatment
• Adhesion to observational study by signing informed consent.

You may not qualify if:

• Inability to follow the observation
• Diagnosis of decompensated psychotic disorders

Sponsors & Collaborators

• L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.: lead
• Solaris CRO: collaborator

Study Sites (5)

Dipartimento DSM, DP area Dipendenze Patologiche, UOSD Ser.T BO est

Bologna, BO, 40138, Italy

Location

Dipartimento delle Dipendenze ASL MI 2

Milan, MI, 20063, Italy

Location

Servizio dipendenze, AUSL

Pescara, PE, 65124, Italy

Location

Dipartimento Dipendenze, ASL TO 2

Torino, TO, 10149, Italy

Location

U.O.C. Ser.T ASL RMC, Distretto 11

Roma, 00178, Italy

Location

Related Publications (1)

• D'Egidio PF, Bignamini E, De Vivo E, Leonardi C, Pieri MC, Gonzalez-Saiz F, Lucchini A; METODO Study Team. METODO, a prospective observational study to assess the efficacy and tolerability of methadone in heroin-addicted patients undergoing a methadone maintenance treatment: preliminary results at baseline evaluation. Subst Use Misuse. 2013 Dec;48(14):1530-40. doi: 10.3109/10826084.2013.800886. Epub 2013 Jul 3.

  PMID: 23822738 BACKGROUND

MeSH Terms

Conditions

Heroin Dependence

Condition Hierarchy (Ancestors)

Opioid-Related Disorders; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Donatella Mariani

  Solaris CRO

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: February 14, 2014
• Study Start: February 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: March 1, 2014
• Last Updated: April 28, 2016

Record last verified: 2016-04

Locations

IT (5)