Investigating a Marijuana-based Compound as a Treatment for Anxiety in Autistic Adults (NCT06526208) | Clinical Trial Compass
RecruitingPhase 2
Investigating a Marijuana-based Compound as a Treatment for Anxiety in Autistic Adults
United States108 participantsStarted 2025-05-28
Plain-language summary
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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or female age 18 to 45 years old with an autism diagnosis.
. Participant is ≥ 100 lbs.
. Participant or a legally authorized representative provides informed consent/assent for participation in the trial.
. Participant/caregiver is willing and able to comply with all study procedures.
. Participant meets ADOS-2 criteria for Autism or Autism Spectrum
. Participant meets DSM-5 criteria for ASD.
. Participant has a minimum CGI-S (Anxiety) score ≥ 5 based on anxiety related social functional impairment.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in baseline on reported anxiety related symptoms
Timeframe: 8 weeks
Trial details
NCT IDNCT06526208
SponsorSouthwest Autism Research & Resource Center
. Participant has a FSIQ ≥ 65 at screening measured with the WASI- II, or within 1 year of screening with a comparable assessment.
Exclusion criteria
. Participant weighs \< 100 lbs.
. Participant is sexually active and does not practice two effective forms of birth control.
. Participant is pregnant, lactating, or planning pregnancy during the study period or within 12 weeks thereafter.
. Participant has a current or historical psychotic features/disorder assessed via the Mini-International Neuropsychiatric Interview (MINI).
. Participant has a current or historical DSM-5 diagnosis of dissociative identity disorder, positive family history (first-degree relative) of psychotic disorder or bipolar disorder type 1.
. At high risk of suicide or suicide attempts.
. Individuals presenting current serious suicide risk, as determined through psychiatric interview, responses to the Columbia Suicide Severity Rating Scale (C-SSRS), and/or clinical judgment of the investigator.
. History of suicide attempts within 12 months prior to study enrollment.