RecruitingPhase 2NCT06526208

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)


Sponsor

Southwest Autism Research & Resource Center

Enrollment

108 participants

Start Date

May 28, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called MB-IMP and Placebo for people with anxiety and autism spectrum disorder. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMB-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.

OTHERPlacebo

Does not contain CBD or THC


Locations(1)

Southwest Autism Research and Resource Center

Phoenix, Arizona, United States

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NCT06526208


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