Opioid AddictionLEVOPROACTNCT03685162
Observational Study to Evaluate Levomethadone Safety and Effectiveness in Subjects Under Opioid Maintenance Treatment
An observational study of Opioid Addiction, run by L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Addiction
- How many people
- 103 participants
- Where
- 1 siteItaly
- Study dates
- 27 Feb 2018to 16 Feb 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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 may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational, Prospective Study to Evaluate Levomethadone Safety Profile and Effectiveness in Subjects Under Opioid Maintenance Treatment
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.
Read the detailed description
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.
The study is divided in two different consecutive parts:
- Part 1 [from Informed Consent form (ICF) to last data collected at V4]: patients enrolled are receiving levomethadone maintenance treatment according to clinical practice.
- Part 2 (after V4 up to FU): patients are in opioid maintenance treatment with any drug (including levomethadone) according to clinical practice.
The maximum duration on-study for a patient will be 405 days [from ICF signature (-30 days from V1) to FU (=360 + 15)]. This study is an open-ended trial. This means that for the enrolment and for the study, no maximum duration has been established.
The study, which is a voluntary Post Authorization Safety Study (PASS), will be carried out on approximately 10 centers in Italy.
The objectives are to provide further data on the safety profile after long term use and effectiveness of levomethadone, administered according Summary of Product Characteristics (SmPC) and in a real word clinical setting, in opioid-addicted patients undergoing maintenance treatment.
Safety will be assessed throughout all the study and safety data will be described and analysed based on Adverse Drug Reactions and corrected QT (QTc) prolongation at 12-lead electrocardiogram (ECG), where available.
The effectiveness outcomes are the evaluation of levomethadone maintenance treatment according to investigator's judgment at V4(180 days), based on different questionnaires and assessment.
- Conditions
- Opioid Addiction
- Keywords
- addiction, opioid addiction, levomethadone, methadone, opioid maintenance treatment
- Medical subject headings
- Opioid-Related Disorders, Behavior, Addictive
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Safety will be described throughout all the study (maximum duration approximately 1 year).
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.
Measured: The effectiveness outcomes will be evaluated at V4 (180 days).
Effectiveness (Substance use)
The patient will register on a diary the use (days) of heroin, buprenorphine, cocaine.
Measured: The effectiveness outcomes will be evaluated at V4 (180 days).
Effectiveness (Presence of Catabolites)
Assessment (negative/positive) of heroin, methadone, buprenorphine, cocaine in urine.
Measured: The effectiveness outcomes will be evaluated at V4 (180 days).
Effectiveness (Retention Rate)
Retention rate (days) in treatment with levomethadone.
Measured: The effectiveness outcomes will be evaluated at V4 (180 days).
Effectiveness (Craving)
Craving will be assessed using by Visual Analogue Scale (VAS) (0-100mm; 0: no craving, 100: maximum craving)
Measured: The effectiveness outcomes will be evaluated at V4 (180 days).
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.
Measured: The effectiveness outcomes will be evaluated at V4 (180 days).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start27 Feb 2018
- Primary completion16 Feb 2023
- Study completion16 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid AddictionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685162
- Sponsor's protocol ID
- MOLT-2015-01
- Acronym
- LEVOPROACT
- Status last verified
- Oct 2023
- First submitted
- 17 Apr 2018
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Prospective Study to Evaluate Levomethadone Safety Profile and Effectiveness in Subjects Under Opioid Maintenance Treatment
- ClinicalTrials.gov ID
- NCT03685162
- Acronym / sponsor ID
- LEVOPROACT / MOLT-2015-01
- Conditions
- Opioid Addiction
- Keywords
- addiction, opioid addiction, levomethadone, methadone, opioid maintenance treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 16 Feb 2023 (actual)
- Study completion
- 16 Feb 2023 (actual)
- First posted
- 26 Sep 2018 (actual)
- 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.
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.
Detailed description
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.
The study is divided in two different consecutive parts:
- Part 1 [from Informed Consent form (ICF) to last data collected at V4]: patients enrolled are receiving levomethadone maintenance treatment according to clinical practice.
- Part 2 (after V4 up to FU): patients are in opioid maintenance treatment with any drug (including levomethadone) according to clinical practice.
The maximum duration on-study for a patient will be 405 days [from ICF signature (-30 days from V1) to FU (=360 + 15)]. This study is an open-ended trial. This means that for the enrolment and for the study, no maximum duration has been established.
The study, which is a voluntary Post Authorization Safety Study (PASS), will be carried out on approximately 10 centers in Italy.
The objectives are to provide further data on the safety profile after long term use and effectiveness of levomethadone, administered according Summary of Product Characteristics (SmPC) and in a real word clinical setting, in opioid-addicted patients undergoing maintenance treatment.
Safety will be assessed throughout all the study and safety data will be described and analysed based on Adverse Drug Reactions and corrected QT (QTc) prolongation at 12-lead electrocardiogram (ECG), where available.
The effectiveness outcomes are the evaluation of levomethadone maintenance treatment according to investigator's judgment at V4(180 days), based on different questionnaires and assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Safety (based on Adverse Drug Reactions)
Time frame: Safety will be described throughout all the study (maximum duration approximately 1 year).
Safety will be assessed throughout all the study and safety data will be described and analysed based on Adverse Drug Reactions.
Effectiveness (Addiction Severity)
Time frame: The effectiveness outcomes will be evaluated at V4 (180 days).
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.
Effectiveness (Substance use)
Time frame: The effectiveness outcomes will be evaluated at V4 (180 days).
The patient will register on a diary the use (days) of heroin, buprenorphine, cocaine.
Effectiveness (Presence of Catabolites)
Time frame: The effectiveness outcomes will be evaluated at V4 (180 days).
Assessment (negative/positive) of heroin, methadone, buprenorphine, cocaine in urine.
Effectiveness (Retention Rate)
Time frame: The effectiveness outcomes will be evaluated at V4 (180 days).
Retention rate (days) in treatment with levomethadone.
Effectiveness (Craving)
Time frame: The effectiveness outcomes will be evaluated at V4 (180 days).
Craving will be assessed using by Visual Analogue Scale (VAS) (0-100mm; 0: no craving, 100: maximum craving)
Effectiveness (Evaluation of Quality of life)
Time frame: The effectiveness outcomes will be evaluated at V4 (180 days).
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.
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 Oct 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Addiction, run by L.Molteni & C. dei F.lli Alitti-Soc. di Esercizio S.p.A. at 1 site in Italy.
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 4 inclusion and 3 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 Oct 2023. 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 Italy. 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.
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?
Safety (based on Adverse Drug Reactions) (time frame: Safety will be described throughout all the study (maximum duration approximately 1 year).). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Oct 2023.