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

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06231849
• Other study ID #: gut microbiota in opioid use
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: April 2026

Study information

• Verified date: January 2024
• Source: Assiut University
• Contact: ahmed mohammed
• Phone: 01069936008
• Email: ahmedbayoud956[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: April 2026
• Est. primary completion date: February 2026
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysbiosis
• Opioid Dependence
• Opioid Use
• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the psychiatric symptoms related to opioid misuse.	The investigator will focus on the following scale: • The Symptom ChickList-90-Revised : psychiatric Symptom related to opioid misuse measured by symptom checklist.	3 months.
Primary	Determine severity of misuse.	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.	3 months.
Primary	Determine type of misuse(whether its just opioid or combined with other substances)	• Laboratory: Urine analysis for substance use(drug screen).	3 months
Secondary	Measuring abundance of gut microbiota	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.	6 months