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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03866941
Other study ID # syntheticcannabinoidsAssiut
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 30, 2021

Study information

Verified date January 2021
Source Assiut University
Contact marwa abdelrahim
Phone +201004514945
Email maarwaa206@gmail.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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


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].


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • 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

Intervention

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).

Locations

Country Name City State
Egypt Egypt Assiut

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary proportion of acute and chronicsynthetic cannibinoids abuser among cases of illicit drugs abuser in studied sites. the magnitude and spread of this new drug of abuse 2 years