NCT06526208

Investigating a Marijuana-based Compound as a Treatment for Anxiety in Autistic Adults

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)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: Southwest Autism Research & Resource Center · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The marijuana-based investigation medical product (MB-IMP) in this study is 23 parts CBD and 1 part THC. The placebo is medium chain triglyceride oil. MB-IMP or placebo will be taken orally. DSM-5 diagnosis of autism spectrum disorder will be confirmed with Autism Diagnostic Observation Schedule, version 2, and review of medical records. History of psychosis, suicidality, cardiac or hepatocellular issues may be exclusionary. The participant must have a study partner who will complete observational assessments regarding the participant\'s behavior. The screening period is 3 weeks to allow for lab results and medical records to be obtained. The active phase of the study (on drug or placebo) is 8 weeks, and their will be one follow-up visit after 14 days off drug.

Conditions

• Autism Spectrum Disorder
• Anxiety

Interventions

Type	Name	Description
DRUG	MB-IMP	MB-IMP is a marijuana-based investigational medical product. It contains a 23:1 ratio of CBD to THC, is an oil-based tincture that is taken orally.
OTHER	Placebo	Does not contain CBD or THC

Timeline

• Start date: 2025-05-28
• Primary completion: 2026-09-30
• Completion: 2027-09-30
• First posted: 2024-07-29
• Last updated: 2026-03-30

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study