Opioid Addiction Clinical Trial
— LEVOPROACTOfficial title:
Observational, Prospective Study to Evaluate Levomethadone Safety Profile and Effectiveness in Subjects Under Opioid Maintenance Treatment
Verified date | October 2023 |
Source | L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 103 |
Est. completion date | February 16, 2023 |
Est. primary completion date | February 16, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Italy | UOC Dipendenze, ASST Papa Giovanni XXIII | Bergamo |
Lead Sponsor | Collaborator |
---|---|
L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety (based on Adverse Drug Reactions) | Safety will be assessed throughout all the study and safety data will be described and analysed based on Adverse Drug Reactions. | Safety will be described throughout all the study (maximum duration approximately 1 year). | |
Primary | Effectiveness (Addiction Severity) | Assessed by Addiction Severity Index (ASI); ASI is a semi-structured interview that consent to assess addiction severity (scale 0-9; 0: no problems, 9: severe problems) of the patient in 7 problem areas. | The effectiveness outcomes will be evaluated at V4 (180 days). | |
Primary | Effectiveness (Substance use) | The patient will register on a diary the use (days) of heroin, buprenorphine, cocaine. | The effectiveness outcomes will be evaluated at V4 (180 days). | |
Primary | Effectiveness (Presence of Catabolites) | Assessment (negative/positive) of heroin, methadone, buprenorphine, cocaine in urine. | The effectiveness outcomes will be evaluated at V4 (180 days). | |
Primary | Effectiveness (Retention Rate) | Retention rate (days) in treatment with levomethadone. | The effectiveness outcomes will be evaluated at V4 (180 days). | |
Primary | Effectiveness (Craving) | Craving will be assessed using by Visual Analogue Scale (VAS) (0-100mm; 0: no craving, 100: maximum craving) | The effectiveness outcomes will be evaluated at V4 (180 days). | |
Primary | Effectiveness (Evaluation of Quality of life) | The evaluation of quality of life will be carried out with the Quality of Life Short-Form Health Survey questionnaire (SF-12). This questionnaire takes into account two domains: Physical Component Summary (PCS-12) and Mental Component Summary (MCS-12) where the lower the score the more disability and the higher the score the less disability. | The effectiveness outcomes will be evaluated at V4 (180 days). |
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