Gut Microbiota Dysbiosis in Opioid Use Disorders: Implications for Clinical Symptoms and Relapse Rate.

Not yet recruiting

• Conditions: Opioid Use; Opioid Use Disorder; Opioid Dependence
• Interventions: Diagnostic Test: stool analysis

• Registration Number: NCT06231849
• Lead Sponsor: Assiut University

Brief Summary

This study will aim to investigate the gut microbiota in Egyptian patients with opioid use disorders and correlate microbiota bacterial abundance with clinical data.

Detailed Description

Addiction is defined as a chronic, relapsing disorder characterized by compulsive drug seeking and use despite adverse consequences. Pathological substance use disorders represent a major public health crisis with limited effective treatment options. Although the gut and brain are separate organs, they communicate with each other via trillions of intestinal bacteria that collectively make up one's gut microbiome. Findings from both humans and animals support a critical role of gut microbes in regulating brain function, mood, and behavior. Gut bacteria influence neural circuits that are notably affected in addiction-related behaviors. These include circuits involved in stress, reward, and motivation, with substance use influencing gut microbial abnormalities, suggesting significant gut-brain interactions in drug addiction.

The investigator will discuss this role of gut microbiome in Assuit university hospital to see how the pathogenesis can be altered of drug addiction.

Study Timeline

• Study First Submitted: 2023-12-27
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-27
• Last Update Submitted: 2024-01-27
• Study First Posted: 2024-01-30
• Last Update Posted: 2024-01-30
• Study Start: 2024-02
• Primary Completion: 2026-02
• Study Completion: 2026-04

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 52

Inclusion Criteria

1. Clinical and laboratory diagnosis of substance missuse.
2. Must be encountering withdrawal symptoms for the first time.

Exclusion Criteria

1. An intelligence quotient (IQ) below 70.
2. Gastrointestinal diseases.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
individuals with opioid use disorders.	stool analysis	Individuals of male gender aged between 20 to 35 years old with opioid use disorders.

Primary Outcome Measures

Name	Time	Method
Determine severity of misuse.	3 months.	Addiction severity index: is an assessment tool used to assess an adult's condition in 7 key problem areas that are typically affected by substance abuse, including medical status, employment, and more, it addresses 7 main aspects of a person's behavior and environment.1 The areas assessed include:1; Medical status. Employment and support. Drug use. Alcohol use. Legal status. Family/social status. Psychiatric status. substance abuse assessment uses the composite score to assign a severity rating. The ratings are based on a scale of 0 to 9 as follows: 0-1: No imminent problem, treatment not indicated. 2-3: Slight problem; treatment may not be necessary. 4-5: Moderate problem, a treatment plan should be considered. 6-7: Considerable difficulty, begin a treatment plan. 8-9: Extreme problem, treatment is vital.
Determine the psychiatric symptoms related to opioid misuse.	3 months.	The investigator will focus on the following scale: • The Symptom ChickList-90-Revised : psychiatric Symptom related to opioid misuse measured by symptom checklist.
Determine type of misuse(whether its just opioid or combined with other substances)	3 months	• Laboratory: Urine analysis for substance use(drug screen).

Secondary Outcome Measures

Name	Time	Method
Measuring abundance of gut microbiota	6 months	The investigator will perform a stool analysis to determine changes in amount of gut microbiota in both intoxication phase and in recovery phase then after 3 month a follow-up test will be conducted to determine the percent of Relapse rate.