Investigating a Marijuana-based Compound as a Treatment for Anxiety in Autistic Adults
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. Rese
| Condition(s) | Autism Spectrum Disorder, Anxiety |
|---|---|
| Status | Recruiting |
| Phase | Phase 2 |
| Study type | Interventional |
| 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 |
| Who can participate | Inclusion Criteria: 1. Male or female age 18 to 45 years old with an autism diagnosis. 2. Participant is ≥ 100 lbs. 3. Participant or a legally authorized representative provides informed consent/assent for participation in the trial. 4. Participant/caregiver is willing and able to comply with all study procedures. 5. Participant meets ADOS-2 criteria for Autism or Autism Spectrum 6. Participant meets DSM-5 criteria for ASD. 7. Participant has a minimum CGI-S (Anxiety) score ≥ 5 based on anxiety related social functional impairment. 8. Participant has a FSIQ ≥ 65 at screening measured with the WASI- II, or within 1 year of screening with a comparable assessment. 9. Participant must have a negative pregnancy test (urine and serum) at Screening, and a negative urine test at Baseline, Active |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Lead sponsor | Southwest Autism Research & Resource Center |
| Locations | Phoenix, Arizona, United States |
| Start date | 2025-05-28 |
| NCT ID | NCT06526208 |
| Official listing | https://clinicaltrials.gov/study/NCT06526208 |