RECRUITING

Cannabidiol (CBD) in Adults With ASD

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Crossover Trial of Cannabidiol (CBD) Versus Placebo for Psychiatric Presentations in Adults With Autism Spectrum Disorder

Quick Facts

Study Start:2023-04-20
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05015439

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ASD based on Diagnostic Statistical Manual 5 (DSM-5) criteria
  2. * 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
  1. * history of alcohol or substance use disorder
  2. * positive urine tetrahydrocannabinol screen at onset of study
  3. * individuals who are pregnant, lactating, or planning pregnancy during or within three months of completing the trial
  4. * individuals with unstable liver disease
  5. * individuals taking medications where CBD interaction might significantly alter drug levels, such as clobazam

Contacts and Locations

Study Contact

Elizabeth Wise, MD
CONTACT
410-550-6207
ewise11@jhmi.edu

Principal Investigator

Elizabeth Wise, MD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

JHBMC
Baltimore, Maryland, 21224
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Elizabeth Wise, MD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-04-20
Study Completion Date2025-12

Study Record Updates

Study Start Date2023-04-20
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Autism Spectrum Disorder