- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03866941
Acute and Chronic Toxicity of Some Synthetic Cannabinoids in Assiut Psychiatric Hospitals
Evaluation of Acute and Chronic Toxicity of Some Synthetic Cannabinoids in Assiut Psychiatric Hospitals (Clinical and Experimental Study)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Synthetic cannabinoids (SCs) are new human-made mind-altering chemicals which are similar to chemicals found in the marijuana plant; they are recent to be used recreationally, especially by young adults[1]. This new generation of novel cannabinoid compounds has been developed to avoid drug control laws and routine cannabinoid blood tests[2].
SCs are dissolved in ethanol or acetone and sprayed on plant material, which is then sold in packets as incense, herbal blends. These products are sold under a variety of names including "Spice," "K2," "Black Mamba," "Scooby Snax" and in Egypt is known as "Voodoo" and "Strox". The chemical constituents and concentrations of compounds vary between and within packages[3].
Voodoo is one of these synthetic Cannabinoids that newly emerged in Egypt targeting the youth causing many reported cases of toxicity. This made the Egyptian Ministry of Health in 2014 to list it in drug schedule 1 and warned traffickers and users that they are now under criminal penalties[4].
Hundreds of SC were categorized into many structural groups and can be detected by Gass chromatography such as adamantoylindoles, aminoalkylindoles, benzoylindoles, cyclohexylphenols, dibenzopyrans, naphthoylindoles, naphthylmethylindoles, naphthylmethylindenes, naphthoylpyrroles, phenylacetylindoles, tetramethylcyclopropyl ketone indoles, quinolinyl ester indoles, and indazole carboxamide compounds[5].
Usually, 0.5 to 3 g of finely cut green/brown plant material is presented in colorful and professionally designed packets. Various herbs such as Pedicularis densiflora, Nymphacea caerulea, Leonotis leonurus, Leonurus sibiricus, Carnavalia maritima, and Zornia latifolia were declared as ingredients [6].
Smoking is the most common reported route of administration of SCs, although oral, pulmonary (via vapourization) and rectal administration has been described[7].
SCs interact with CB1 and CB2 cannabinoid receptors and elicit cannabimimetic effects similar to Δ9-tetrahydrocannabinol (THC), the primary psychoactive constituent in cannabis[8]. Although SC drugs mimic the psychotropic effects of cannabis, their undesired effects are unpredictable and more severe than those associated with cannabis[9].
SCs can result in acute, chronic and withdrawal manifestations[10]. Similar to cannabis, the acute intoxication of SCs may induce manifestations such as relaxation, euphoria, perceptual alteration, altered sense of time, and mild cognitive impairments [11]. Other adverse effects include confusion, dizziness, drowsiness, agitation, irritability, nausea, vomiting, hallucinations, delusions, increased heart rate, hypertension, vertigo and mydriasis [12-14]. Less common cardiac effects include chest pain, myocardial infarction, cardiac arrest and acute kidney damage[15].
Cases of synthetic cannabis abuse were associated with the manifestation of violence in Egypt and worldwide [16, 17]. These cognitive alterations increase the risk of road accidents if cannabis or SC users drive while intoxication[18]. Moreover, Psychoactive substances are often regarded as possible contributing causal factors in cases of violent injuries, sexual abuse, and homicides[15].
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: marwa abdelrahim
- Phone Number: +201004514945
- Email: maarwaa206@gmail.com
Study Contact Backup
- Name: Assiut university
- Phone Number: +088 2332278
- Email: med@aun.edu.eg
Study Locations
-
-
-
Assiut, Egypt, 71515
- Recruiting
- Egypt
-
Contact:
- marwa abdelrahim
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- All the cases with the primary diagnosis of acute or chronic synthetic cannabinoids toxicity will be included in the study.
- Willing and able to comply with the study procedures and provide written informed consent to participate in the study.
Exclusion Criteria:
- 1- Patients with a history of any chronic disease (renal and hepatic). 2- Patients refuse to participate in the study. 3- Abuse to other drugs.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
synthetic cannibinoids users
|
Epidemiological data (age, sex, residence, occupation, route of abuse, the cause of abuse and smoking) (2) Symptoms and signs (seizures, psychosis, hallucinations) (3) Injuries and their relation to violence (type of wound, type of instrument, number of injuries, external or internal injuries and assailant or victim).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
proportion of acute and chronicsynthetic cannibinoids abuser among cases of illicit drugs abuser in studied sites.
Time Frame: 2 years
|
the magnitude and spread of this new drug of abuse
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Wafaa Abdel Moneim, Assiut Univesity
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- syntheticcannabinoidsAssiut
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Epidemiologic Data of Some Synthetic Cannibinoids Toxicity in Patients Presenting at Assiut University Hospital, Psychiatric Hospital of Ministry of Health)
-
Assiut UniversityNot yet recruitingGenetic Disease Clinical Presentation in Patients Attending Genetics Outpatient Clinic of Assiut University Children Hospital
Clinical Trials on causes of abuse synthetic cannibinoids
-
Institut PasteurThe University of Hong Kong; University of Lausanne; University of Lausanne Hospitals and other collaboratorsTerminatedMicrocephaly | Congenital InfectionSri Lanka, Vietnam, Cameroon, China, Côte D'Ivoire
-
University Hospital, RouenRecruitingIntrauterine Fetal DeathFrance
-
Lille Catholic UniversityInstitut Pasteur de LilleUnknown
-
NYU Langone HealthNew York UniversityRecruiting
-
University of DundeeWellcome Trust; Diabetes UKCompletedDiabetic Neuropathic PainUnited Kingdom
-
University of MinnesotaRecruiting
-
Radboud University Medical CenterTheia Foundation, Zilveren Kruis AchmeaTerminatedImproved Recognition of Partner Abuse | Gender Differences in Discussing Partner Abuse | Abused Women's Expectations,Experiences | Abused Women's Health Care UtilisationNetherlands
-
University Hospital Inselspital, BerneAbbott; University Hospital, Zürich; Bangerter-Rhyner StiftungRecruitingAtrial Fibrillation | MINOCASwitzerland
-
ER/LA Opioid REMS Program Companies (RPC)UnknownDrug Abuse | Opioid-related Disorders | Narcotic Abuse | Opioid Addiction
-
Medical University of ViennaSeibersdorf Labor GmbH; Ludwig Boltzmann Institute for Digital Health and PreventionRecruitingOut-Of-Hospital Cardiac Arrest | Cardiopulmonary ArrestAustria