Nctid:
NCT06231849
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D064806", "term"=>"Dysbiosis"}, {"id"=>"D009293", "term"=>"Opioid-Related Disorders"}, {"id"=>"D019966", "term"=>"Substance-Related Disorders"}], "ancestors"=>[{"id"=>"D010335", "term"=>"Pathologic Processes"}, {"id"=>"D000079524", "term"=>"Narcotic-Related Disorders"}, {"id"=>"D064419", "term"=>"Chemically-Induced Disorders"}, {"id"=>"D001523", "term"=>"Mental Disorders"}], "browseLeaves"=>[{"id"=>"M30405", "name"=>"Dysbiosis", "asFound"=>"Dysbiosis", "relevance"=>"HIGH"}, {"id"=>"M12244", "name"=>"Opioid-Related Disorders", "asFound"=>"Opioid Use Disorder", "relevance"=>"HIGH"}, {"id"=>"M21837", "name"=>"Substance-Related Disorders", "asFound"=>"Opioid Use Disorder", "relevance"=>"HIGH"}, {"id"=>"M2057", "name"=>"Narcotic-Related Disorders", "relevance"=>"LOW"}, {"id"=>"M30302", "name"=>"Chemically-Induced Disorders", "relevance"=>"LOW"}, {"id"=>"M14473", "name"=>"Psychotic Disorders", "relevance"=>"LOW"}, {"id"=>"M4815", "name"=>"Mental Disorders", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Substance Related Disorders", "abbrev"=>"BC25"}, {"name"=>"Behaviors and Mental Disorders", "abbrev"=>"BXM"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4033", "name"=>"Analgesics, Opioid", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Analgesics", "abbrev"=>"Analg"}, {"name"=>"Central Nervous System Depressants", "abbrev"=>"CNSDep"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"bioSpec"=>{"retention"=>"SAMPLES_WITH_DNA", "description"=>"stool analysis to determine the number of gut microbiota in individuals with opioid use disorders."}, "studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>52}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-02", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2026-04", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-27", "studyFirstSubmitDate"=>"2023-12-27", "studyFirstSubmitQcDate"=>"2024-01-27", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-30", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2026-02", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Determine the psychiatric symptoms related to opioid misuse.", "timeFrame"=>"3 months.", "description"=>"The investigator will focus on the following scale:\n\n• The Symptom ChickList-90-Revised : psychiatric Symptom related to opioid misuse measured by symptom checklist."}, {"measure"=>"Determine severity of misuse.", "timeFrame"=>"3 months.", "description"=>"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\n\nMedical 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."}, {"measure"=>"Determine type of misuse(whether its just opioid or combined with other substances)", "timeFrame"=>"3 months", "description"=>"• Laboratory: Urine analysis for substance use(drug screen)."}], "secondaryOutcomes"=>[{"measure"=>"Measuring abundance of gut microbiota", "timeFrame"=>"6 months", "description"=>"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."}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["gut microbiota .", "Opioid use"], "conditions"=>["Opioid Use", "Opioid Use Disorder", "Opioid Dependence"]}, "referencesModule"=>{"references"=>[{"pmid"=>"27868217", "type"=>"BACKGROUND", "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."}, {"pmid"=>"29145012", "type"=>"BACKGROUND", "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."}, {"pmid"=>"22487042", "type"=>"BACKGROUND", "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."}]}, "descriptionModule"=>{"briefSummary"=>"This study will aim to investigate the gut microbiota in Egyptian patients with opioid use disorders and correlate microbiota bacterial abundance with clinical data.", "detailedDescription"=>"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.\n\nThe investigator will discuss this role of gut microbiome in Assuit university hospital to see how the pathogenesis can be altered of drug addiction."}, "eligibilityModule"=>{"sex"=>"MALE", "stdAges"=>["ADULT"], "maximumAge"=>"35 years", "minimumAge"=>"20 years", "genderBased"=>true, "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"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.", "genderDescription"=>"biological sex", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Clinical and laboratory diagnosis of substance missuse.\n2. Must be encountering withdrawal symptoms for the first time.\n\nExclusion Criteria:\n\n1. An intelligence quotient (IQ) below 70.\n2. Gastrointestinal diseases."}, "identificationModule"=>{"nctId"=>"NCT06231849", "briefTitle"=>"Gut Microbiota Dysbiosis in Opioid Use Disorders: Implications for Clinical Symptoms and Relapse Rate.", "organization"=>{"class"=>"OTHER", "fullName"=>"Assiut University"}, "officialTitle"=>"Gut Microbiota Dysbiosis in Opioid Use Disorders: Implications for Clinical Symptoms and Relapse Rate.", "orgStudyIdInfo"=>{"id"=>"gut microbiota in opioid use"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"normal subjects without opioid intoxications.", "description"=>"1. Individuals of male gender aged between 20 to 35 years old"}, {"label"=>"individuals with opioid use disorders.", "description"=>"Individuals of male gender aged between 20 to 35 years old with opioid use disorders.", "interventionNames"=>["Diagnostic Test: stool analysis"]}], "interventions"=>[{"name"=>"stool analysis", "type"=>"DIAGNOSTIC_TEST", "description"=>"stool analysis to determine number of gut microbiota in subjects with opioid use and its effect on its intoxication.", "armGroupLabels"=>["individuals with opioid use disorders."]}]}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"ahmed mohammed", "role"=>"CONTACT", "email"=>"ahmedbayoud956@gmail.com", "phone"=>"01069936008"}], "overallOfficials"=>[{"name"=>"Alaa El-Din Darwish Othman, professor", "role"=>"STUDY_CHAIR", "affiliation"=>"assiutbird25@aun.edu.eg"}, {"name"=>"GeLLan Karamallah Ramadan, doctor", "role"=>"STUDY_DIRECTOR", "affiliation"=>"gillankaram@aun.edu.eg"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Assiut University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Resident doctor", "investigatorFullName"=>"ahmed mohammed abdelrahim", "investigatorAffiliation"=>"Assiut University"}}}}
