Trial · NCT04517799
Trial of Cannabidiol to Treat Severe Behavior Problems in Children With Autism
NCT04517799, Phase 2, Active not recruiting, University of California, San Diego
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Trial of Cannabidiol to Treat Severe Behavior Problems in Children With Autism. Trials, record NCT04517799. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04517799
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Trial of Cannabidiol to Treat Severe Behavior Problems in Children With Autism
- NCT number
- NCT04517799
- Status
- Active not recruiting
- Phases
- Phase 2
- Enrollment
- 42 participants, actual
- Lead sponsor
- University of California, San Diego
- Conditions
- Autism, Autism Spectrum Disorder
- Interventions
- Epidiolex, placebo oral solution
- First posted
- 2020-08-18
- Last updated
- 2025-09-30
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Score on Repetitive Behavior Scale-Revised (RBS-R) | Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks) | This scale aims to capture the frequency and severity of the repetitive and restricted behaviors that are a common feature in individuals with autism spectrum disorders. The RBS-R has been validated and has been shown to have high internal consistency and inter-rater reliability when used in outpatient settings. There are 5 subscales: Stereotypic Behavior, Self-Injurious Behavior, Compulsive Behavior, Ritualistic/Sameness Behavior, and Restricted Interests. This scale will be administered to the parent or caregiver, who will report on the child's recent behaviors. Changes in score from baseline to end of treatment will be estimated - one observed during the period of treatment with the Placebo and another during the CBD treatment - with negative value representing improvement in negative behaviors and positive value representing worsening of those characteristics. |
| Primary | Total Score on Child Behavior Checklist (CBCL) | Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks) | The CBCL is a widely used test that assesses problem behaviors in children by posing questions to the parent or caregiver. It poses questions about a wide range of potential negative behaviors including aggression, rule-breaking, and social problems. The school-aged scale, which will be used in this study, consists of 118 questions. The CBCL has 8 syndrome scales, including Aggressive Behavior, Anxiety/Depressed, Attention Problems, Rule-breaking, Somatic Complaints, Social Problems, Thought Problems, and Withdrawn/Depressed. Changes in score from baseline to end of treatment will be estimated - one observed during the period of treatment with the Placebo and another during the CBD treatment - with negative value representing improvement in negative behaviors and positive value representing worsening of those characteristics. |
| Primary | Autism Diagnostic Observation Scale- 2 (ADOS-2) | Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks) | This a widely used scale that diagnoses autism spectrum disorders across individuals with a broad range of ages, developmental levels, and language abilities. It is a semi-structured assessment and consists of behavioral observation and coding of relevant behaviors. The ADOS-2 evaluates communication, social interaction, and imaginative play. The child is asked to complete various activities and then rated on their performance by the tester. Time of administration is 40-60 minutes. Range of scores is 1-10. Changes in score from baseline to end of treatment will be estimated - one observed during the period of treatment with the Placebo and another during the CBD treatment - with negative value representing improvement in negative behaviors and positive value representing worsening of those characteristics. |
| Secondary | Total Score on Aberrant Behavior Checklist (ABC) | Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks) | This checklist relies upon parent/caregiver report to assess problematic behaviors. These behaviors are divided into 5 subscales: irritability, social withdrawal, stereotypic behavior, hyperactivity/noncompliance, and inappropriate speech. |
| Secondary | Total Score on Social Responsiveness Scale | Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks) | Formerly known as the Social Reciprocity Scale, this 65 item questionnaire takes a quantitative approach to measuring autistic symptomatology. It obtains "first-hand" ratings from individuals (in this case, parents) who have observed the child in naturalistic social settings. The SRS poses questions about a child's ability to engage in emotionally appropriate reciprocal social interactions, It generates a singular severity score for autistic social impairment (higher score equates with greater severity), use of which has been validated by extensive factor and cluster analyses among clinical and nonclinical populations. |
| Secondary | Total Score on Peabody Picture Vocabulary test (PPVT-4) | Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks) | The PPVT-4 is a measure of receptive vocabulary for Standard American English. For this study we will use standard scores. |
| Secondary | Total Score on Expressive One Word Picture Vocabulary test, Fourth Edition (EOWPVT-4) | Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks) | This test assesses the individual's ability to name a variety of objects, actions, and concepts. Participants in this study are expected to have limited verbal abilities. This test will evaluate the degree of impairment at baseline and then following treatment. Administration takes less than twenty minutes. |
| Secondary | Total Score on Children's Sleep Habits Questionnaire (CSHQ) | Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks) | This is a retrospective, 45-item parent questionnaire that has been used in a number of studies to examine sleep behavior in young children. Thirty-two items on the CSHQ are grouped into 8 subscales relating to a number of key sleep domains: (1) bedtime resistance (6 items); (2) sleep-onset delay (1 item); (3) sleep duration (3 items); (4) sleep anxiety (4 items); (5) night wakings (3 items); (6) parasomnias (7 items); (7) sleep-disordered breathing (2 items); and (8) daytime sleepiness (8 items). Parents are asked to recall sleep behaviors occurring during a typical recent week. A higher score is indicative of more disturbed sleep. |
| Other | Magnetic Resonance Spectroscopy | Start to finish of period 1 (8 weeks) and start to finish of period 2 (8 weeks) | Analyses will include levels of GABA and other compounds that can be identified in MR spectra; changes in those compounds with treatment; and connectivity of different brain regions before and after treatment. MRS will examine the peaks of various neurotransmitters (glutamate, glutamine, markers of neuronal integrity (NAA) and markers of metabolic function (lactate, alanine). |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 40410546 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests1
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as |
|---|---|
| Vocabulary Test | Secondary outcome |
Source ConductCognition
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04517799
GET https://conductscience.org/api/trials/v1/NCT04517799/registered