Cannabidiol (CBD) in Adults With ASD

NCT05015439 | Recruiting Phase 1 FDA Drug

• 1 other identifier: IRB00267739
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• Change in Aberrant Behaviors as assessed by the Aberrant Behavior Checklist

  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/noncompliance consists of 16 items, and inappropriate speech consists of 4 items. The total score can range from a minimum of 0 (no problem behaviors) to a maximum of 174, with higher numbers indicating worse symptoms.

  baseline and six weeks

Secondary Outcomes (10)

• Change in Anxiety as assessed by the Hamilton Anxiety Rating Scale

  baseline and six weeks

• Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS)

  baseline and six weeks

• Change in Clinical Global Impression Scale-Improvement (CGI)

  baseline and six weeks

• Change in neuropsychiatric symptomatology as assessed by the Neuropsychiatric Inventory Questionnaire (NPI-Q)

  baseline and six weeks

• Change in Waisman Activities of Daily Living scale

  baseline and six weeks

Study Arms (2)

Cannabidiol

EXPERIMENTAL

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.

Drug: Cannabidiol

Placebo

PLACEBO COMPARATOR

Participants will receive six weeks of placebo.

Drug: Placebo

Interventions

Cannabidiol DRUG

The study intervention will be supplied as a softgel capsule containing cannabidiol.

Also known as: CBD

Cannabidiol

Placebo DRUG

The study intervention will be supplied as a softgel capsule containing inert filler.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASD based on Diagnostic Statistical Manual 5 (DSM-5) criteria
• a significant mood disorder, sleep disturbance, or exhibit agitation, aggression, or other aberrant behavior that is interfering with function and quality of life, as determined by their psychiatric interview

You may not qualify if:

• history of alcohol or substance use disorder
• positive urine tetrahydrocannabinol screen at onset of study
• individuals who are pregnant, lactating, or planning pregnancy during or within three months of completing the trial
• individuals with unstable liver disease
• individuals taking medications where CBD interaction might significantly alter drug levels, such as clobazam

Sponsors & Collaborators

• Johns Hopkins University: lead
• Charlotte's Web, Inc: collaborator

Study Sites (1)

JHBMC

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Cannabidiol

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Elizabeth Wise, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Wise, MD

CONTACT

410-550-6207; ewise11@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2021
• First Posted: August 20, 2021
• Study Start: April 20, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)