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Clinical Trials/NCT06231849
NCT06231849
Not yet recruiting
Not Applicable

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

Assiut University0 sites52 target enrollmentStarted: February 2024Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
52
Primary Endpoint
Determine severity of misuse.

Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
20 Years to 35 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • An intelligence quotient (IQ) below
  • Gastrointestinal diseases.

Outcomes

Primary Outcomes

Determine severity of misuse.

Time Frame: 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.

Time Frame: 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)

Time Frame: 3 months

• Laboratory: Urine analysis for substance use(drug screen).

Secondary Outcomes

  • Measuring abundance of gut microbiota(6 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

ahmed mohammed abdelrahim

Resident doctor

Assiut University

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