Opioid UseNCT06231849
Gut Microbiota Dysbiosis in Opioid Use Disorders: Implications for Clinical Symptoms and Relapse Rate.
An observational study of Opioid Use and Opioid Use Disorder, run by Assiut University.
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. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men only
- Conditions the study is for
- Opioid Use, Opioid Use Disorder, Opioid Dependence
- What is being tested?
- stool analysis
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Men only
- No healthy volunteers
- Adult
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.
Who may be able to join
- Clinical and laboratory diagnosis of substance missuse.
- Must be encountering withdrawal symptoms for the first time.
Who cannot join
- An intelligence quotient (IQ) below 70.
- Gastrointestinal diseases.
Trial locations and contacts
No sites are listed yet.
About this study
This study will aim to investigate the gut microbiota in Egyptian patients with opioid use disorders and correlate microbiota bacterial abundance with clinical data.
Read the 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.
- Conditions
- Opioid Use, Opioid Use Disorder, Opioid Dependence
- Being tested
- stool analysis
- Keywords
- gut microbiota ., Opioid use
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stool analysisDiagnostic test
stool analysis to determine number of gut microbiota in subjects with opioid use and its effect on its intoxication.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: stool analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 months.
Determine type of misuse(whether its just opioid or combined with other substances)
- Laboratory: Urine analysis for substance use(drug screen).
Measured: 3 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study startFeb 2024 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionApr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed mohammed abdelrahim, Assiut University
- Investigators
- Alaa El-Din Darwish Othman, professor, Study chair, assiutbird25@aun.edu.egGeLLan Karamallah Ramadan, doctor, Study director, gillankaram@aun.edu.eg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06231849
- Sponsor's protocol ID
- gut microbiota in opioid use
- Status last verified
- Jan 2024
- First submitted
- 27 Dec 2023
- Last updated
- 30 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27868217Akbarali 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.
PubMed 29145012Berridge 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.
PubMed 22487042
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gut Microbiota Dysbiosis in Opioid Use Disorders: Implications for Clinical Symptoms and Relapse Rate.
- ClinicalTrials.gov ID
- NCT06231849
- Acronym / sponsor ID
- gut microbiota in opioid use
- Conditions
- Opioid Use, Opioid Use Disorder, Opioid Dependence
- Keywords
- gut microbiota ., Opioid use
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 30 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal subjects without opioid intoxications. | – | –1. Individuals of male gender aged between 20 to 35 years old |
| individuals with opioid use disorders. | – | Diagnostic Test: stool analysisIndividuals of male gender aged between 20 to 35 years old with opioid use disorders. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Clinical and laboratory diagnosis of substance missuse.
- Must be encountering withdrawal symptoms for the first time.
Key exclusion criteria (2 listed)
- An intelligence quotient (IQ) below 70.
- Gastrointestinal diseases.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stool analysisstool analysis to determine number of gut microbiota in subjects with opioid use and its effect on its intoxication. | Diagnostic test | individuals with opioid use disorders. |
Primary outcome
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 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 type of misuse(whether its just opioid or combined with other substances)
Time frame: 3 months
• Laboratory: Urine analysis for substance use(drug screen).
1 secondary outcome
Measuring abundance of gut microbiota
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Background: PubMed 27868217Acharya 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.
- Background: PubMed 29145012Akbarali 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.
- Background: PubMed 22487042Berridge 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alaa El-Din Darwish Othman, professor study chair
assiutbird25@aun.edu.eg
GeLLan Karamallah Ramadan, doctor study director
gillankaram@aun.edu.eg
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Use and Opioid Use Disorder, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact ahmed mohammed (01069936008, ahmedbayoud956@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the psychiatric symptoms related to opioid misuse. (time frame: 3 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06231849, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.