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Trial record 3 of 57 for:    Recruiting, Not yet recruiting, Available Studies | NOT (Use Disorders OR Marijuana Use OR Dependence OR Abuse OR Drug Use) | cannabinoids

Acute and Chronic Toxicity of Some Synthetic Cannabinoids in Assiut Psychiatric Hospitals

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ClinicalTrials.gov Identifier: NCT03866941
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : March 7, 2019
Sponsor:
Information provided by (Responsible Party):
MKMAbdelrahim, Assiut University

Brief Summary:
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. This new generation of novel cannabinoid compounds have been developed to avoid drug control laws and routine cannabinoid blood tests

Condition or disease Intervention/treatment
Epidemiologic Data of Some Synthetic Cannibinoids Toxicity in Patients Presenting at Assiut University Hospital, Psychiatric Hospital of Ministry of Health) Proportion of Acute and Chronic Abusers of Synthetic Cannibinoids Among Cases of Illicit Drugs Abuser in Studied Sites Behavioral: causes of abuse synthetic cannibinoids

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].


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 3 Days
Official Title: Evaluation of Acute and Chronic Toxicity of Some Synthetic Cannabinoids in Assiut Psychiatric Hospitals (Clinical and Experimental Study)
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : December 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
synthetic cannibinoids users Behavioral: causes of abuse synthetic cannibinoids
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).




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
all cases diagnosed as acute or chronic synthetic cannibinoids toxicity which admitted to Emergency unit, Neuro-PsychatryUniversity Hospital - Assiut University and Psychiatric hospital of ministry of health
Criteria

Inclusion Criteria:

  1. All the cases with the primary diagnosis of acute or chronic synthetic cannabinoids toxicity will be included in the study.
  2. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03866941


Contacts
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Contact: marwa abdelrahim +201004514945 maarwaa206@gmail.com
Contact: Assiut university +088 2332278 med@aun.edu.eg

Locations
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Egypt
Egypt Recruiting
Assiut, Egypt, 71515
Contact: marwa abdelrahim         
Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Wafaa Abdel Moneim assiut univesity

Additional Information:

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Responsible Party: MKMAbdelrahim, assistant lecturer, Assiut University
ClinicalTrials.gov Identifier: NCT03866941     History of Changes
Other Study ID Numbers: syntheticcannabinoidsAssiut
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: March 7, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by MKMAbdelrahim, Assiut University:
synthetic cannabinoids, Assiut, violence,acute,chronic