Who is sponsoring NCT04520685?

NCT04520685 is sponsored by University of Colorado, Denver.

What drugs are being tested in NCT04520685?

Interventions in NCT04520685: Oral cannabidiol 100mg/mL, Placebo.

What condition does NCT04520685 study?

NCT04520685 studies Autism Spectrum Disorder.

Is NCT04520685 still recruiting?

NCT04520685 is currently active, enrolled. Last updated 8 May 2024.

Last reviewed 2024-05-08 · How we verify

NCT04520685: CASCADE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

CASCADE: CAnnabidiol Study in Children With Autism Spectrum DisordEr

Active, enrolled Phase 2 Last updated 8 May 2024

What this trial tests

Phase 2 trial testing Oral cannabidiol 100mg/mL in Autism Spectrum Disorder in 86 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 December 2021

Primary endpoint
31 January 2024

31 December 2024

Quick facts

Lead sponsor	University of Colorado, Denver
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	86
Start date	15 December 2021
Primary completion	31 January 2024
Estimated completion	31 December 2024
Sites	1 location across United States

Drugs / interventions tested

Oral cannabidiol 100mg/mL — full drug profile →
Placebo

Conditions studied

Autism Spectrum Disorder — all drugs for Autism Spectrum Disorder →

Sponsor

University of Colorado, Denver

Who can join

Adults 5 to 17, any sex, with Autism Spectrum Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a randomized, placebo-controlled study but all study participants will receive the active study medication at some point during the study for at least 12 weeks, and some children with receive CBD for the entire study.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

The therapeutic potential of purified cannabidiol.
O'Sullivan SE, Jensen SS, Nikolajsen GN, Bruun HZ, et al · · 2023 · cited 33× · PMID 37312194 · DOI 10.1186/s42238-023-00186-9
Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD).
Iffland M, Livingstone N, Jorgensen M, Hazell P, et al · · 2023 · cited 21× · PMID 37811711 · DOI 10.1002/14651858.cd011769.pub2
The role of cannabinoids in neurodevelopmental disorders of children and adolescents.
Dias-de Freitas F, Pimenta S, Soares S, Gonzaga D, et al · · 2022 · cited 8× · PMID 36169325 · DOI 10.33588/rn.7507.2022123
Medical Cannabis in Pediatric Oncology: Friend or Foe?
Malach M, Kovalchuk I, Kovalchuk O. · · 2022 · cited 8× · PMID 35337156 · DOI 10.3390/ph15030359
Clinical Data on Canabinoids: Translational Research in the Treatment of Autism Spectrum Disorders.
Carreira LD, Matias FC, Campos MG. · · 2022 · cited 2× · PMID 35453548 · DOI 10.3390/biomedicines10040796
Cannabidiol for treatment of irritability and aggressive behavior in children and adolescents with autism spectrum disorder: background and methods of the cannabidiol study in children with autism spectrum disorder study.
Sannar EM, Winter J, Franke RK, Werner E, et al · · 2025 · cited 1× · PMID 41103807 · DOI 10.18203/2349-3259.ijct20250131

Verify or expand the search:

Other recruiting trials for Autism Spectrum Disorder

Currently open trials in the same condition.

NCT07324057 — The Effects of Preoperative Intranasal Administration of Dexmedetomidine and Esketamine on Negative Postoperative Behavi · NA · recruiting
NCT07493096 — Intensive Multimodal Neurorehabilitation Targeting Neuroplasticity in Pediatric Neurodevelopmental and Chromosomal Disor · recruiting
NCT07505290 — Efficacy of the Korean PEERS® for Preschoolers (PEERS®-PS-K) Social Skills Intervention: A Randomized Controlled Trial f · NA · active not recruiting
NCT07524192 — A Self-Instructional Online Program for Early Childhood and Elementary Teachers Supporting Autistic Children and Childre · NA · recruiting
NCT07432776 — Effect of an 8-Week Pickleball Program for Adults With Autism: A Feasibility Trial With a Delayed-Control Design · EARLY_PHASE1 · recruiting

Other University of Colorado, Denver trials

Trials by the same sponsor.

NCT07292285 — The Surveillance Nonoperative Watch & Wait (SNOWW) Rectal Cancer Trial. · not yet recruiting
NCT07021937 — Brain Plasticity and GLP-1 Receptor Agonist Treatment for Obesity · Phase 3 · not yet recruiting
NCT07453732 — Banana Leaves as a Wound Dressing for Partial Thickness Second Degree Burns in Adult Patients. · NA · not yet recruiting
NCT07038278 — 5-AminoLevulinic Acid Aided Resection Margins in Sarcoma · EARLY_PHASE1 · not yet recruiting
NCT07279558 — Cannabidiol and Alcohol Use Disorder Phenotypes · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04520685 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Colorado, Denver
Last refreshed: 8 May 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04520685.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing