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 range18 Years – 45 Years
SexALL
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.
✓. 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.
✕
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 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.