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

NCT06231849 | Not Yet Recruiting

• 1 other identifier: gut microbiota in opioid use
• Study Type: observational
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Opioid Use; Opioid Use Disorder; Opioid Dependence

Keywords

gut microbiota .; Opioid use

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• Determine type of misuse(whether its just opioid or combined with other substances)

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

  3 months

Secondary Outcomes (1)

• Measuring abundance of gut microbiota

  6 months

Study Arms (2)

normal subjects without opioid intoxications.

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

individuals with opioid use disorders.

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

Diagnostic Test: stool analysis

Interventions

stool analysis DIAGNOSTIC_TEST

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

individuals with opioid use disorders.

Eligibility Criteria

• Age: 20 Years - 35 Years
• Gender Eligibility Details: biological sex
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Patients in the intoxication stage of addiction will be initially included and undergo a comprehensive psychiatric and medical assessment. This assessment will be repeated one month later when patients transition into the withdrawal stage, and finally, a follow-up assessment will occur three months later. On the other hand, healthy control group will be matched in age and gender will be recruited.

You may qualify if:

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

You may not qualify if:

• An intelligence quotient (IQ) below 70.
• Gastrointestinal diseases.

Sponsors & Collaborators

• Assiut University: lead

Related 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.

  PMID: 27868217 BACKGROUND

• 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.

  PMID: 29145012 BACKGROUND

• 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.

  PMID: 22487042 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

stool analysis to determine the number of gut microbiota in individuals with opioid use disorders.

MeSH Terms

Conditions

Opioid-Related Disorders

Interventions

Occult Blood

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Alaa El-Din Darwish Othman, professor

  assiutbird25@aun.edu.eg

  STUDY CHAIR

• GeLLan Karamallah Ramadan, doctor

  gillankaram@aun.edu.eg

  STUDY DIRECTOR

Central Study Contacts

ahmed mohammed

CONTACT

01069936008; ahmedbayoud956@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: December 27, 2023
• First Posted: January 30, 2024
• Study Start: February 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: April 1, 2026
• Last Updated: January 30, 2024

Record last verified: 2024-01