What side effects are associated with this type of intervention?

Common treatments for Autism Spectrum Disorder (ASD) that modulate the endocannabinoid system, such as Cannabidiol (CBD), have been studied for their potential to alleviate symptoms like anxiety, mood disturbances, and agitation. Known side effects of CBD include gastrointestinal issues (e.g., nausea, diarrhea), dizziness, sedation, and changes in appetite. Other treatments, such as omega-3 fatty acids, have been associated with mild gastrointestinal distress but are generally well-tolerated. It is important to note that while these treatments may offer some benefits, the evidence is often limited and inconsistent, and they should be used with caution, particularly in patients with specific sensitivities or underlying conditions.

What prior FDA approvals exist?

There are no FDA-approved treatments specifically for autism spectrum disorder (ASD) that modulate the endocannabinoid system, such as cannabidiol (CBD). While CBD is being studied for its potential benefits in treating psychiatric symptoms associated with ASD, including anxiety, mood disturbances, and agitation, it has not yet received FDA approval for this use. Other treatments for ASD typically focus on behavioral therapies and medications targeting specific symptoms, but none are approved that work through the endocannabinoid system.

What other types of research exist?

Promising alternatives to CBD for autism patients include FAAH inhibitors, which prevent the breakdown of anandamide, potentially enhancing its effects on neurotransmitter release. Anandamide modulation itself is another option due to its motivational and reinforcing properties. Gabapentin, known for its different mechanism of action, may also be considered for treating anxiety, mood disturbances, and agitation in autism patients.

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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

Must not have

Individuals with unstable liver disease

Individuals taking medications where CBD interaction might significantly alter drug levels, such as clobazam

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and six weeks

Summary

This trial is testing if cannabidiol (CBD) can help with anxiety, mood issues, sleep problems, and agitation in adults with autism spectrum disorder (ASD). Participants will take CBD pills for a period of time. The study aims to see if CBD is effective and safe for these psychiatric problems. Cannabidiol (CBD) has shown promise in treating psychotic symptoms and anxiety, but there is not enough high-quality evidence for its clinical use in psychiatric disorders.

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My liver disease is not stable.

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I am not on medications like clobazam that CBD could significantly affect.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and six weeks

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Aberrant Behaviors as assessed by the Aberrant Behavior Checklist

Secondary study objectives

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

29%

Tiredness

20%

Constipation

18%

Drowsiness

11%

Poor sleep

11%

Dizziness

Poor Appetite

Headache

Nausea

Itching

Diarrhea

100%

80%

60%

40%

20%

Study treatment Arm

Control Group

CBD Oil 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

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Autism, such as Cannabidiol (CBD), work by modulating the endocannabinoid system, which influences neurotransmitter release and can reduce symptoms of anxiety, mood disturbances, and agitation. This is significant for Autism patients as it addresses some of the core challenges they face. Additionally, therapies like therapeutic horseback riding and animal-assisted therapy improve social behaviors and reduce stress, enhancing overall social cognition and communication.

The histamine H3R antagonist DL77 attenuates autistic behaviors in a prenatal valproic acid-induced mouse model of autism.The effects of anandamide signaling enhanced by the FAAH inhibitor URB597 on coping styles in rats.Lessons from nonmammalian species.