Epigenetic Biomarker for Opioid Use Disorder

NCT05419986 | Terminated

• 1 other identifier: 8484
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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 life experiences, altogether determining OUD severity. Recently, behavioral epigenetics has emerged as a possible strategy to help identify molecular mechanisms that may explain how these various interactions result in dysregulations affecting gene expression, brain function, and, ultimately, emotional regulation. Here the investigators propose a pilot study as a first step towards a larger multidisciplinary project whose goal will be to characterize simultaneously major psychiatric and social factors in individuals with OUD, across a wide range of disease severity. In the present pilot study, the investigators propose to first characterize technical feasibility of the molecular investigations proposed in these 2 projects. OUD severity The severity of OUD is well defined in the DSM-5 (2013), with 3 categories, from mild to severe, on the basis of the number of dimensional criteria met by patients (among 11 criteria). These criteria relate to the following main aspects: tolerance, the need to increase the amount of drugs to avoid withdrawal; psychic and physic withdrawal in case of substance discontinuation; social and interpersonal consequences of drug use; biological and psychic consequences of use; and craving, the irrepressible need to consume1. Here, the investigators postulate that molecular adaptations detected in the blood of OUD patients may represent biomarkers of this severity. Epigenetic blood biomarkers A main limitation for conducting peripheral blood biomarker investigations in active opioid abusers comes from the fact that phlebotomies are reputedly difficult \& potentially iatrogenic in these subjects, as they associate with external cues and trigger internal states that are closely related to drug consumption. To overcome this difficulty, we propose to test the hypothesis that sufficient DNA amounts can be recovered from fingerstick blood drops (corresponding to capillary blood, similar to sugar testing) to generate robust and reliable DNA methylation measures in the full human epigenome. In other words, the investigators assume that DNA methylation can be measured using capillary blood. Objectives The investigators will first investigate in healthy volunteers whether the method consisting in collecting and analyzing small DNA amounts from capillary blood (fingerstick blood drops) retrieves DNA methylation measures for a number of CG dinucleotide sites (where DNA methylation occurs in the mammalian genome) that is comparable to that classically observed using veinous blood (phlebotomy). Second, the investigators will test the feasibility of measuring DNA methylation using capillary blood samples collected from patients with OUD. To this purpose, the investigators propose to collect veinous and capillary blood samples from healthy volunteers, and capillary blood from opioid users.

Conditions

Opioid Use Disorder; Addiction

Outcome Measures

Primary Outcomes (1)

• Comparison of DNA methylation between fingerstick drop samples and venous samples

  Quantitative description of the number of CG dinucleotide sites where sufficient coverage can be obtained (\>5X) in blood samples collected by fingerstick blood drops versus venous blood samples, using Reduced Representation Enzymatic Methylation Sequencing (RREMseq), in healthy volunteers and in subjects with OUD.

  1 day

Secondary Outcomes (1)

• Correlation between Opioid Use Disorder (OUD) severity and DNA methylation in capillary blood samples of patients with OUD

  1 day

Study Arms (2)

Non-opioid users

OTHER

Genetic: Blood collection

Active opioid users

OTHER

Genetic: Blood collection

Interventions

Blood collection GENETIC

Molecular monitoring by measure of DNA methylation levels in blood samples collected by fingerstick blood drops, as opposed to veinous phlebotomy

Active opioid users; Non-opioid users

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Impossibility of giving information to the subject (subject in an emergency situation, difficulties in understanding the subject, etc.)
• 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.

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Laurence LALANNE

Strasbourg, 67091, France

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Behavior, Addictive

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Compulsive Behavior; Impulsive Behavior; Behavior

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Laurence LALANNE

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2022
• First Posted: June 15, 2022
• Study Start: June 23, 2022
• Primary Completion: September 15, 2022
• Study Completion: February 7, 2023
• Last Updated: April 25, 2023

Record last verified: 2023-04

Locations

FR (1)