Clinical trial NCT06231849: Gut Microbiota Dysbiosis in Opioid Use Disorders: Implications for Clinical Symptoms and Relapse Rate.
Official title: Gut Microbiota Dysbiosis in Opioid Use Disorders: Implications for Clinical Symptoms and Relapse Rate.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Opioid Use
Opioid Use Disorder
Opioid Dependence
Keywords: gut microbiota .
Opioid use
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 52
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine the psychiatric symptoms related to opioid misuse.
timeFrame: 3 months.
measure: Determine severity of misuse.
timeFrame: 3 months.
measure: Determine type of misuse(whether its just opioid or combined with other substances)
timeFrame: 3 months
Secondary outcomes:
measure: Measuring abundance of gut microbiota
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: assiutbird25@aun.edu.eg
name: Alaa El-Din Darwish Othman, professor
role: STUDY_CHAIR
affiliation: gillankaram@aun.edu.eg
name: GeLLan Karamallah Ramadan, doctor
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.