The goal of this clinical trial is to learn if drug ABC works to treat severe asthma in adults. It will also learn about the safety of drug ABC. The main questions it aims to answer are: Will a marijuana-based drug help anxiety in autistic adults? Anxiety can make socializing and working more difficult for people. Researchers will compare a marijuana based drug (that is mostly CBD with a small amount of THC) to a placebo (a look-alike substance that contains no drug) to see if the drug makes symptoms of anxiety better. Participants will take the drug (or a placebo) every day for 8 weeks and keep a diary to record the time they took the drug, and their feelings each day. The drug is taken orally in drops once or twice a day. The study staff will speak to the participants weekly either over the phone or in the clinic. Clinic visits once every 2 weeks for checkups and tests. The researchers will make sure participants are healthy and see if there are any changes in anxiety.
The marijuana-based investigation medical product (MB-IMP) in this study is 23 parts CBD and 1 part THC. The placebo is medium chain triglyceride oil. MB-IMP or placebo will be taken orally. DSM-5 diagnosis of autism spectrum disorder will be confirmed with Autism Diagnostic Observation Schedule, version 2, and review of medical records. History of psychosis, suicidality, cardiac or hepatocellular issues may be exclusionary. The participant must have a study partner who will complete observational assessments regarding the participant\'s behavior. The screening period is 3 weeks to allow for lab results and medical records to be obtained. The active phase of the study (on drug or placebo) is 8 weeks, and their will be one follow-up visit after 14 days off drug.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
108
Southwest Autism Research and Resource Center
Phoenix, Arizona, United States
RECRUITINGChange in baseline on reported anxiety related symptoms
The Clinical Global Impression Scale for Severity will be used to measure the change in anxiety related symptoms. We hypothesize a two point reduction in severity and
Time frame: 8 weeks
Change in socialization
We will measure the Change in behaviors related to socialization with the Social Responsiveness Scale
Time frame: 8 weeks
Change in repetitive behaviors from baseline to the end of study
We will measure the amount of repetitive behaviors with the Repetitive Behavior Scale- Revised
Time frame: 8 weeks.
We will measure the change in a variety of aberrant behaviors from baseline to end of study
Study partners will complete the Aberrant Behavior Checklist at every clinic visit.
Time frame: 8 weeks
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