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Cannabidiol (CBD) in Adults With ASD

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05015439
Recruitment Status : Not yet recruiting
First Posted : August 20, 2021
Last Update Posted : October 24, 2022
Sponsor:
Collaborator:
Canopy Growth Corporation
Information provided by (Responsible Party):
Johns Hopkins University

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.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Drug: Cannabidiol Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Crossover Trial of Cannabidiol (CBD) Versus Placebo for Psychiatric Presentations in Adults With Autism Spectrum Disorder
Estimated Study Start Date : November 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : March 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arm Intervention/treatment
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.
Drug: Cannabidiol
The study intervention will be supplied as a softgel capsule containing cannabidiol.
Other Name: CBD

Placebo Comparator: Placebo
Participants will receive six weeks of placebo.
Drug: Placebo
The study intervention will be supplied as a softgel capsule containing inert filler.




Primary Outcome Measures :
  1. Change in Aberrant Behaviors as assessed by the Aberrant Behavior Checklist [ Time Frame: baseline and six weeks ]
    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.


Secondary Outcome Measures :
  1. Change in Anxiety as assessed by the Hamilton Anxiety Rating Scale [ Time Frame: baseline and six weeks ]
    Change from baseline and end of six-week arm on Hamilton Anxiety Rating Scale (HAM-A), which is a 14-item clinician-rated scale to measure severity of anxiety, with higher scores indicating higher anxiety. Each question is ranked on a scale of 0, indicating not present, to 4, indicating very severe. Total scores range from 0-56 with higher scores indicating greater anxiety

  2. Change in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) [ Time Frame: baseline and six weeks ]
    Change from baseline and end of six-week arm on Yale-Brown Obsessive Compulsive Scale (Y-BOCS). The Y-BOCS is a 10-item clinician-rated scale to measure obsessions and compulsions. The Y-BOCS includes five rating dimensions for obsessions and compulsions: time spent or occupied; interference with functioning or relationships; degree of distress; resistance; and control. The 10 Y-BOCS items are each scored on a four-point scale from 0 indicating "no symptoms" to 4 indicating "extreme symptoms." The sum of the first five items is a severity index for obsessions, and the sum of the last five an index for compulsions. Total scores range from 0-40 with higher scores indicating greater obsessive compulsiveness.

  3. Change in Clinical Global Impression Scale-Improvement (CGI) [ Time Frame: baseline and six weeks ]
    Change from baseline and end of six-week arm on Clinical Global Impression Scale (CGI). The CGI is a clinician-rated assessment of global improvement. The CGI-Improvement measures change from the initiation of treatment on a seven-point scale. The CGI-Improvement has the clinician compare the individual's overall clinical condition to the one week period just prior to the initiation of treatment. The score ranges from 1, very much improved, to 7 very much worse since initiation of treatment, with lower scores indicating more improvement.

  4. Change in neuropsychiatric symptomatology as assessed by the Neuropsychiatric Inventory Questionnaire (NPI-Q) [ Time Frame: baseline and six weeks ]
    Change from baseline and end of six-week arm on Neuropsychiatric Inventory Questionnaire (NPI-Q). The NPI-Q measures severity and caregiver distress related to 12 different neuropsychiatric symptoms. Each of the 12 NPI-Q domains contains a survey question to reflect cardinal symptoms of that domain. Initial responses to each domain question are "Yes" (present) or "No" (absent). If "Yes", the informant rates both the Severity of the symptoms present within the last month on a 3-point scale (1 is mild, 3 is severe) and the associated impact of the symptom manifestations on them (i.e. Caregiver Distress) using a 5-point scale (0 not distressing, 5 extreme or very severe). The NPI-Q provides symptom Severity and Distress ratings for each symptom reported, and total Severity and Distress scores reflecting the sum of individual domain scores. The total score ranges from 0 to 36.

  5. Change in Waisman Activities of Daily Living scale [ Time Frame: baseline and six weeks ]
    Change from baseline and end of six-week arm on Waisman Activities of Daily Living scale, which was developed for adolescents and adults with developmental disabilities. The Waisman Activities of Daily Living scale rates the participant's level of independence in 17 different daily living tasks, such as making his/her own bed to banking and managing finances. Each task is rated 0, does not do at all, to 2, independent/does on own. Scale ranges from 0 (no independence in daily living skills) to 34 (independent in daily living skills), with higher scores reflecting more independence in daily living skills.

  6. Change in Social Communication Questionnaire [ Time Frame: baseline and six weeks ]
    Change from baseline and end of six-week arm on Social Communication Questionnaire (SCQ). The SCQ is a 40-item yes/no questionnaire that screens for ASD. ASD is suspected with a score of 15 or higher.

  7. Change in Mini Mental State Examination (MMSE) [ Time Frame: baseline and six weeks ]
    Change from baseline on cognition using the Mini Mental State Examination (MMSE). The MMSE examines cognitive domains of orientation, memory, language, attention, and visuospatial. The score ranges from 0 as most cognitively impaired to 30 as no cognitive impairment detected on the screen, with lower scores reflecting more cognitive impairment.

  8. Change in Adverse Effects- Drug Effect Questionnaire (DEQ) Subjective [ Time Frame: baseline and six weeks ]
    Change from baseline on frequency of adverse effects using the Drug Effect Questionnaire (DEQ). The DEQ, through 18 questions, determines subjective ratings of cannabis intoxication using a 100-mm visual analog scale anchored with "not at all" at one end and "extremely" at the other end. This method is sensitive to detecting acute effects of cannabis. The score is determined by the distance between the left anchor point and the participant's mark on the line. Each item is scored separately. The score ranges from 0 to 1800, with higher scores indicating a more acute drug effect.

  9. Change in Adverse Effects- Drug Effect Questionnaire (DEQ) Informant [ Time Frame: baseline and six weeks ]
    Change from baseline on frequency of adverse effects using the Drug Effect Questionnaire (DEQ). The DEQ, through 18 questions, determines ratings of cannabis intoxication using a 100-mm visual analog scale anchored with "not at all" at one end and "extremely" at the other end. The score is determined by the distance between the left anchor point and the participant's mark on the line. Each item is scored separately. The informant answers for the participant, indicating how acutely affected the participant appears. The score ranges from 0 to 1800, with higher scores indicating a more acute drug effect.

  10. Change in Adverse Effects- Medication Side-Effects Questionnaire [ Time Frame: baseline and six weeks ]
    Change from baseline on frequency of adverse effects using the Medication Side-Effects Questionnaire. The Questionnaire lists potential side effects of CBD rated on a four-point scale (none, mild, moderate, strong). Based on the list of potential side effects from trials of CBD, items will include diarrhea, somnolence, fever, decreased appetite, vomiting, dry mouth, restlessness, irritability, and coughing. The scores range from 0 to 36 with higher scores indicating more severe medication side effects.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05015439


Contacts
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Contact: Elizabeth Wise, MD 410-550-6207 ewise11@jhmi.edu

Sponsors and Collaborators
Johns Hopkins University
Canopy Growth Corporation
Investigators
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Principal Investigator: Elizabeth Wise, MD Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT05015439    
Other Study ID Numbers: IRB00267739
First Posted: August 20, 2021    Key Record Dates
Last Update Posted: October 24, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Cannabidiol
Anticonvulsants