NCT03685162

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

September 26, 2018

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 16, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 16, 2023

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

5 years

First QC Date

April 17, 2018

Last Update Submit

October 23, 2023

Conditions

Opioid Addiction

Keywords

addictionopioid addictionlevomethadonemethadoneopioid maintenance treatment

Outcome Measures

Primary Outcomes (7)

  • 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).

  • 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).

  • 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).

  • Effectiveness (Presence of Catabolites)

    Assessment (negative/positive) of heroin, methadone, buprenorphine, cocaine in urine.

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

  • Effectiveness (Retention Rate)

    Retention rate (days) in treatment with levomethadone.

    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)

    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.

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UOC Dipendenze, ASST Papa Giovanni XXIII

Bergamo, Italy

Location

MeSH Terms

Conditions

Opioid-Related DisordersBehavior, Addictive

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental DisordersCompulsive BehaviorImpulsive BehaviorBehavior

Study Design

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

Study Record Dates

First Submitted

April 17, 2018

First Posted

September 26, 2018

Study Start

February 27, 2018

Primary Completion

February 16, 2023

Study Completion

February 16, 2023

Last Updated

October 24, 2023

Record last verified: 2023-10

Locations

IT(1)