CompletedNot Applicable

Observational Study to Evaluate Levomethadone Safety and Effectiveness in Subjects Under Opioid Maintenance Treatment

Italy103 participantsStarted 2018-02-27

Plain-language summary

Multicentre, prospective, observational, non-interventional, open- ended trial, collecting data from male and female patients aged ≥ 18 years, with a diagnosis of opioid addiction according to ICD-10 (F11.2), treated with therapeutic doses of levomethadone according to the routine medical practice.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Male and female patients, aged ≥ 18 years; * Patients with a diagnosis of opioid addiction according to ICD-10 (ICD 10 F11.2); * Opioid-addicted patients initiating or currently undergoing a maintenance treatment with levomethadone as part of their routine clinical care and according to the approved SmPC; * Patients or legal guardian when applicable must provide their written informed consent to participate in the study. Exclusion Criteria: * Inability to understand study procedures; * Any contraindication stated in the SmPC for the administration of levomethadone according to investigator's judgment; * Patients currently participating in any other clinical trial.

What they're measuring

Safety (based on Adverse Drug Reactions)

Timeframe: Safety will be described throughout all the study (maximum duration approximately 1 year).

Effectiveness (Addiction Severity)

Timeframe: The effectiveness outcomes will be evaluated at V4 (180 days).

Effectiveness (Substance use)

Timeframe: The effectiveness outcomes will be evaluated at V4 (180 days).

Effectiveness (Presence of Catabolites)

Timeframe: The effectiveness outcomes will be evaluated at V4 (180 days).

Effectiveness (Retention Rate)

Timeframe: The effectiveness outcomes will be evaluated at V4 (180 days).

Effectiveness (Craving)

Timeframe: The effectiveness outcomes will be evaluated at V4 (180 days).

Effectiveness (Evaluation of Quality of life)

Timeframe: The effectiveness outcomes will be evaluated at V4 (180 days).

Trial details

NCT IDNCT03685162

SponsorL.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-02-16

View on ClinicalTrials.gov More Opioid Addiction trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Safety (based on Adverse Drug Reactions)

Timeframe: Safety will be described throughout all the study (maximum duration approximately 1 year).

Effectiveness (Addiction Severity)

Timeframe: The effectiveness outcomes will be evaluated at V4 (180 days).

Effectiveness (Substance use)

Timeframe: The effectiveness outcomes will be evaluated at V4 (180 days).

Effectiveness (Presence of Catabolites)

Timeframe: The effectiveness outcomes will be evaluated at V4 (180 days).

Effectiveness (Retention Rate)

Timeframe: The effectiveness outcomes will be evaluated at V4 (180 days).

Effectiveness (Craving)

Timeframe: The effectiveness outcomes will be evaluated at V4 (180 days).

Effectiveness (Evaluation of Quality of life)

Timeframe: The effectiveness outcomes will be evaluated at V4 (180 days).