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

NCT06526208 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2026-03-30

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Southwest Autism Research & Resource Center

    lead OTHER

Principal Investigators

  • Christopher J Smith, Ph.D. · SARRC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-28
Primary Completion
2026-09-30
Completion
2027-09-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06526208 on ClinicalTrials.gov