Epigenetic Biomarker for Opioid Use Disorder

Not Applicable

Terminated

• Conditions: Opioid Use Disorder; Addiction

• Registration Number: NCT05419986
• Lead Sponsor: University Hospital, Strasbourg, France

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-10
• Study First Submitted QC: 2022-06-10
• Study First Posted: 2022-06-15
• Study Start: 2022-06-23
• Primary Completion: 2022-09-15
• Study Completion: 2023-02-07
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-21
• Last Update Posted: 2023-04-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Comparison of DNA methylation between fingerstick drop samples and venous samples	1 day	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.

Secondary Outcome Measures

Name	Time	Method
Correlation between Opioid Use Disorder (OUD) severity and DNA methylation in capillary blood samples of patients with OUD	1 day	1. Quantitative description of the number of subjects with severe OUD (meeting at least 6 out of 11 DSM-5 criteria) / without severe OUD (less than 6 criteria); 2. Preliminary quantitative description of DNA methylation levels in capillary blood samples from patients with / without severe OUD

Trial Locations

Locations (1)

Laurence LALANNE; 🇫🇷 Strasbourg, France