Phase 2 Randomized Placebo-controlled, Double-blind, Parallel Study to Assess the Safety and Efficacy of an Oral Marijuana-Based Investigational Medical Product to Treat Anxiety in Adults With Autism Spectrum Disorder (ASD)
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.
• 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.
• Participant must have a negative pregnancy test (urine and serum) at Screening, and a negative urine test at Baseline, Active Phase Visits, and EoS visits, see Table 1. Schedule of Activities.
⁃ Sexually active participants agree to use two methods of effective birth control, as described in Appendix B: Contraceptive and Barrier Guidance during the study intervention period and for at least 14 days after the Study Termination visit.
⁃ Participant must be stable on any pre-study medications and/or psychotherapy for 6-weeks prior to study enrollment, agree to inform prescribing clinician(s) about participation in the study, and agree to maintain medication or psychotherapy treatment regimen during the study.
⁃ Participant must be able to ingest MB-IMP (or placebo) and be willing to commit to medication dosing and completing the dosing diary.
⁃ Participant/caregiver agrees to keep all study medication provided by site staff securely stored at home and not to share/distribute study medication to any other individual.
⁃ Participant agrees not to participate in any other interventional clinical trials during the study period.
⁃ Participant agrees to inform the investigators within 48- hours of any side-effects, medical conditions, and procedures.
⁃ Participant agrees to abstain from alcohol use during the study.