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NCT05015439 · ClinicalTrials.gov registry record · Phase 1
Cannabidiol (CBD) in Adults With ASD
A Phase 1 study of Autism Spectrum Disorder, sponsored by Johns Hopkins University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT05015439: Recruiting Phase 1 study of Autism Spectrum Disorder, sponsored by Johns Hopkins University.
NCT05015439 is a Phase 1 study of Autism Spectrum Disorder that is actively recruiting participants, run by Johns Hopkins University. The registered enrollment target is 40 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (70% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05015439, a Phase 1 study of Autism Spectrum Disorder, is actively recruiting participants, sponsored by Johns Hopkins University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
There are no FDA approved treatments for use in adults with autism spectrum disorder (ASD), many of whom have distressing anxiety, mood disturbances, sleep problems, and agitation. Some researchers and individuals with ASD have noted that cannabidiol (CBD) is beneficial for those psychiatric problems. This study is to learn more about the effectiveness and safety of CBD in the treatment of psychiatric problems in adults with ASD. The study will last 14 weeks total, during which six weeks participants will receive a pill containing CBD, two weeks where participants will receive no drug/placebo, and six weeks where participants will receive the placebo, an inactive pill. As part of the study, participants will have regular visits and be asked questions about anxiety, challenging behaviors, daily functioning, cognition, and physical symptoms, on standard assessments.
Primary Outcome
The Aberrant Behavior Checklist (ABC) assesses drug and other treatment effects on individuals with intellectual disability or other developmental disabilities. The ABC consists of a five-factor scale comprising 58 items. Problem behaviors are rated on a categorical scale between 0 (not at all a problem) and 3 (problem is severe in degree). The irritability subscale consists of 15 items, lethargy/social withdrawal consists of 16 items, stereotypic behavior consists of 7 items, hyperactivity/nonc
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Cannabidiol
Study Locations (1)
Maryland
- JHBMC - Baltimore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-04-20 |
| Est. Completion | 2026-12 |
| Phase | Phase 1 |
What NCT05015439 shows while recruiting
NCT05015439 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (70% lower).
The record links to 1 condition, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT05015439 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT05015439 about?
NCT05015439 is a clinical study titled "Cannabidiol (CBD) in Adults With ASD". There are no FDA approved treatments for use in adults with autism spectrum disorder (ASD), many of whom have distressing anxiety, mood disturbances, sleep problems, and agitation. Some researchers and individuals with ASD have noted that cannabidiol (CBD) is beneficial for those psychiatric problem...
What is the current status of trial NCT05015439?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2023-04-20. Estimated completion is 2026-12.
What conditions does trial NCT05015439 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder.
What interventions are being tested in trial NCT05015439?
The interventions under investigation include: Placebo (DRUG), Cannabidiol (DRUG).
Who is sponsoring clinical trial NCT05015439?
This trial is sponsored by Johns Hopkins University, which has 1,448 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05015439 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Autism Spectrum Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05015439's enrollment target sits among peer trials
40 156th of 224 higher than 61 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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