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Cannabinoids for Behavioral Problems in Children With ASD

NCT02956226 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2018-12-27

No results posted yet for this study

Summary

This study aims to assess the safety, tolerability and efficacy of cannabinoids mix \[cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio, BOL Pharma, Israel\] for behavioral problems in children and youth with ASD.

Conditions

  • Autistic Disorder

Interventions

DRUG

Cannabinoids - 99% pure cannabinoids mix

99% pure cannabidiol (CBD) and 99% pure Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio (B.O.L Pharma, Israel), in a 160/8.0 mg per mL (CBD/THC) olive oil-based solution.

DRUG

Placebo

Olive oil and flavors solution.

DRUG

Cannabinoids - whole plant extract

Whole plant extract enriched with cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) to achieve 20:1 ratio (B.O.L Pharma, Israel), in a 160/8.0 mg per mL (CBD/THC) olive oil-based solution.

Sponsors & Collaborators

  • Shaare Zedek Medical Center

    lead OTHER

Principal Investigators

  • Adi Aran, MD · Shaare Zedek Medical Center

  • Varda Gross · Shaare Zedek Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2018-10-31
Completion
2018-12-31

Countries

  • Israel

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02956226 on ClinicalTrials.gov