Cannabidiol (CBD) in Adults With ASD

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT05015439
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Cannabidiol — DRUG
    The study intervention will be supplied as a softgel capsule containing cannabidiol.
  • Placebo — DRUG
    The study intervention will be supplied as a softgel capsule containing inert filler.

Study Details

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.

Key Dates

Start date
Apr 20, 2023
Status verified
Nov 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
JHBMCBaltimoreMaryland21224-

Find similar trials in Baltimore, MD

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
JHBMC· Baltimore, MD

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