Recruiting
Phase 1

Cannabidiol

Sponsor:

Johns Hopkins University

Code:

NCT05015439

Conditions

Autism Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cannabidiol

Placebo

Study Details

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

Study ID

NCT05015439

Start date

Apr 20, 2023

Status verified date

Nov, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cannabidiol

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.

placebo comparator: Placebo

Participants will receive six weeks of placebo.

Interventions

Cannabidiol

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

Placebo

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

Primary outcome measure

  • Change in Aberrant Behaviors as assessed by the Aberrant Behavior Checklist [ Time Frame: baseline and six weeks ]

Central Contacts and Locations

Central contacts

Elizabeth Wise, MD

410-550-6207ewise11@jhmi.edu

Locations

JHBMC

Recruiting

Baltimore, Maryland, United States, 21224

More Information

Sponsor

Johns Hopkins University

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2025-11-10.