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Cannabinoid

CBD for Autism

Phase 1
Recruiting
Led By Elizabeth Wise, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and six weeks
Awards & highlights

Study Summary

This trialis researching if CBD can help adults with autism, who have psychiatric problems, to improve their anxiety, mood, sleep and agitation. Participants will receive CBD and placebo pills for 14 weeks and be monitored for changes.

Who is the study for?
Adults with Autism Spectrum Disorder (ASD) experiencing mood disorders, sleep disturbances, or agitation can join this trial. They must meet DSM-5 criteria for ASD and have symptoms affecting their life quality. Excluded are those with substance abuse history, positive THC tests, pregnancy or lactation plans soon after the trial, unstable liver disease, or on certain medications.Check my eligibility
What is being tested?
The study is testing Cannabidiol (CBD)'s effectiveness in treating psychiatric issues in adults with ASD over a 14-week period. Participants will take CBD pills for six weeks, no treatment for two weeks, then placebo pills for another six weeks while undergoing regular assessments.See study design
What are the potential side effects?
Potential side effects of CBD may include tiredness, diarrhea changes in appetite/weight but specific side effects related to this trial haven't been listed; they'll be monitored through regular visits and assessments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and six weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and six weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Aberrant Behaviors as assessed by the Aberrant Behavior Checklist
Secondary outcome measures
Change in Adverse Effects- Drug Effect Questionnaire (DEQ) Informant
Change in Adverse Effects- Drug Effect Questionnaire (DEQ) Subjective
Change in Adverse Effects- Medication Side-Effects Questionnaire
+7 more

Side effects data

From 2022 Phase 2 & 3 trial • 90 Patients • NCT04387617
38%
Tiredness
24%
Drowsiness
24%
Poor sleep
22%
Constipation
18%
Poor Appetite
16%
Dizziness
9%
Headache
7%
Diarrhea
7%
Nausea
4%
Itching
100%
80%
60%
40%
20%
0%
Study treatment Arm
CBD Oil Group
Control Group

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: CannabidiolExperimental Treatment1 Intervention
Participants will receive cannabidiol, starting at 100 mg twice daily, and increased to 200 mg twice daily by week 3. This arm will last six weeks.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive six weeks of placebo.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cannabidiol
2021
Completed Phase 3
~1010

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,263 Previous Clinical Trials
14,823,125 Total Patients Enrolled
Canopy Growth CorporationIndustry Sponsor
13 Previous Clinical Trials
1,114 Total Patients Enrolled
Elizabeth Wise, MDPrincipal InvestigatorJohns Hopkins University

Media Library

Cannabidiol (Cannabinoid) Clinical Trial Eligibility Overview. Trial Name: NCT05015439 — Phase 1
Autism Research Study Groups: Placebo, Cannabidiol
Autism Clinical Trial 2023: Cannabidiol Highlights & Side Effects. Trial Name: NCT05015439 — Phase 1
Cannabidiol (Cannabinoid) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05015439 — Phase 1
Autism Patient Testimony for trial: Trial Name: NCT05015439 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted authorization for Cannabidiol usage?

"With limited clinical data supporting Cannabidiol's safety and efficacy, we rate its security a modest 1 on the risk scale."

Answered by AI

What is the aggregate figure for participants in this research effort?

"Yes, perusal of clinicaltrials.gov reveals that this trial is currently searching for suitable patients to enrol in its study. The posting was initiated on December first 2022 and updated lastly on November twenty-ninth the same year. A total of 40 people will be enrolled at a single site."

Answered by AI

Has Cannabidiol been explored in other scientific research?

"At present, 79 trials for Cannabidiol are in motion with 16 of those experiments currently occupying Phase 3. Despite the bulk of the studies taking place in Ribeirao Preto, Sao Paulo, there exists a total number of 290 sites which conducting these clinical tests."

Answered by AI

Are there any remaining vacancies for participants to join this research?

"Confirmed, this research has been posted to clinicaltrials.gov and is actively seeking enrollees. It was initially uploaded on December 1st 2022 and the information was most recently modified on November 29th 2022."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
What site did they apply to?
JHBMC
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

Application made by medical POA. Continues to struggle with anxiety and would like to improve of alleviate symptoms.
PatientReceived no prior treatments
Recent research and studies
clinicaltrials.govStudy
Cannabidiol (CBD) in Adults With ASD
2023. "Cannabidiol (CBD) in Adults With ASD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05015439.
All > Asd > Epidiolex
~13 spots leftby Nov 2024
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