Actively Recruiting
Investigating a Marijuana-based Compound as a Treatment for Anxiety in Autistic Adults
Led by Southwest Autism Research & Resource Center · Updated on 2026-03-30
108
Participants Needed
1
Research Sites
122 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Investigating a Marijuana-based Compound as a Treatment for Anxiety in Autistic Adults
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female age 18 to 45 years old with an autism diagnosis.
- Participant weighs at least 100 lbs.
- Participant or legally authorized representative provides informed consent/assent.
- Participant or caregiver is willing and able to follow all study procedures.
- Participant meets Autism Diagnostic Observation Schedule, version 2 (ADOS-2) criteria for autism or autism spectrum.
- Participant meets DSM-5 criteria for autism spectrum disorder.
- Participant has a minimum Clinical Global Impression-Severity (CGI-S) anxiety score of 5 or higher based on social functional impairment.
- Participant has a full scale IQ (FSIQ) of 65 or higher within 1 year of screening.
- Female participants must have negative urine and serum pregnancy tests at screening and negative urine tests at baseline, during treatment, and at end of study visits.
- Sexually active participants agree to use two effective forms of birth control during the study and for at least 14 days after.
- Participant is stable on any pre-study medications or psychotherapy for at least 6 weeks and agrees to maintain treatment during the study.
- Participant is able to take the study drug orally and willing to complete medication dosing and diary.
- Participant or caregiver agrees to keep study medication secure and not share it.
- Participant agrees not to participate in other interventional clinical trials during this study.
- Participant agrees to report any side effects, medical conditions, or procedures within 48 hours.
- Participant agrees to abstain from alcohol use during the study.
You will not qualify if you...
- Participant weighs less than 100 lbs.
- Sexually active participants who do not use two effective forms of birth control.
- Pregnant, lactating, or planning pregnancy during the study or within 12 weeks after.
- Current or past psychotic disorders.
- Current or past diagnosis of dissociative identity disorder or family history of psychotic or bipolar type 1 disorder.
- High risk of suicide or suicide attempts currently or within the past 12 months.
- Current substance use disorder within 12 months prior to enrollment.
- Positive urine drug screen for opiates, methamphetamine, cocaine, THC, or amphetamines unless prescribed (participants with positive THC may rescreen after 1 month of cessation, max twice).
- History of arrhythmia within 12 months unless successfully treated and stable.
- Uncontrolled or significant hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal, renal, immunocompromising, or neurological disease.
- Evidence of liver injury with elevated liver enzymes or bilirubin.
- Known allergies or sensitivities to cannabis.
- Unable to attend required visits or plans to move away during treatment period.
- Investigator or medical monitor deems participant inappropriate for study for any reason.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Southwest Autism Research and Resource Center
Phoenix, Arizona, United States, 85006
Actively Recruiting
Research Team
C
Christopher J Smith, Ph.D.
CONTACT
B
Brian Shaw
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here