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

NCT ID: NCT06231849

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-29

Study Completion Date

2026-04-30

Brief Summary

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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

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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.

Conditions

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Opioid Use Opioid Use Disorder Opioid Dependence

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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normal subjects without opioid intoxications.

1\. Individuals of male gender aged between 20 to 35 years old

No interventions assigned to this group

individuals with opioid use disorders.

Individuals of male gender aged between 20 to 35 years old with opioid use disorders.

stool analysis

Intervention Type DIAGNOSTIC_TEST

stool analysis to determine number of gut microbiota in subjects with opioid use and its effect on its intoxication.

Interventions

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stool analysis

stool analysis to determine number of gut microbiota in subjects with opioid use and its effect on its intoxication.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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ahmed mohammed abdelrahim

Resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alaa El-Din Darwish Othman, professor

Role: STUDY_CHAIR

[email protected]

GeLLan Karamallah Ramadan, doctor

Role: STUDY_DIRECTOR

[email protected]

Central Contacts

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ahmed mohammed

Role: CONTACT

01069936008

References

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Acharya C, Betrapally NS, Gillevet PM, Sterling RK, Akbarali H, White MB, Ganapathy D, Fagan A, Sikaroodi M, Bajaj JS. Chronic opioid use is associated with altered gut microbiota and predicts readmissions in patients with cirrhosis. Aliment Pharmacol Ther. 2017 Jan;45(2):319-331. doi: 10.1111/apt.13858. Epub 2016 Nov 20.

Reference Type BACKGROUND
PMID: 27868217 (View on PubMed)

Akbarali HI, Dewey WL. The gut-brain interaction in opioid tolerance. Curr Opin Pharmacol. 2017 Dec;37:126-130. doi: 10.1016/j.coph.2017.10.012. Epub 2017 Nov 13.

Reference Type BACKGROUND
PMID: 29145012 (View on PubMed)

Berridge KC. From prediction error to incentive salience: mesolimbic computation of reward motivation. Eur J Neurosci. 2012 Apr;35(7):1124-43. doi: 10.1111/j.1460-9568.2012.07990.x.

Reference Type BACKGROUND
PMID: 22487042 (View on PubMed)

Other Identifiers

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gut microbiota in opioid use

Identifier Type: -

Identifier Source: org_study_id

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