Status:
TERMINATED
Epigenetic Biomarker for Opioid Use Disorder
Lead Sponsor:
University Hospital, Strasbourg, France
Conditions:
Opioid Use Disorder
Addiction
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Study rationale Opioid use disorder (OUD) is a chronic and severe condition, defined by problematic opioid use, which results from interactions among sociological factors, psychiatric symptoms and lif...
Eligibility Criteria
Inclusion
- Inclusion criteria
- First step:
- Healthy volunteers subjects (men or women) at least 18 years old
- Subjects affiliated to a social health insurance scheme
- Able to understand the objectives and risks of the research and to give dated and signed informed consent
- Without any drug use except tobacco consumption and/or occasional alcohol consumption (defined by not more than 21 drinks per week for men and note more than 14 drinks per week for women)
- Second step :
- Subjects (Male or female) active opioid users at least 18 years old
- Subjects affiliated to a social health insurance scheme
- Able to understand the objectives and risks of the research and to give dated and signed informed consent
- Exclusion criteria:
- Impossibility of giving information to the subject (subject in an emergency situation, difficulties in understanding the subject, etc.)
- Subjects in an exclusion period (determined by a previous or current study),
- Subjects already participating to another study with an investigational product
- Subjects under court protection (patients deprived of freedom because of a judicial measure)
- Subjects under guardianship or curatorship
- Subjects with severe psychiatric disease (bipolar disorder, schizophrenia, chronic psychotic disorder) Authorized and/or prohibited drugs/treatments
- No treatment or drug use will be authorized for healthy volunteers during the first step study (with exceptions for occasional alcohol or tobacco use).
- All treatments will be authorized for the step 2 study in opioid users.
Exclusion
Key Trial Info
Start Date :
June 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 7 2023
Estimated Enrollment :
11 Patients enrolled
Trial Details
Trial ID
NCT05419986
Start Date
June 23 2022
End Date
February 7 2023
Last Update
April 25 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Laurence LALANNE
Strasbourg, France, 67091