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Cannabis-based Therapy

Marijuana-based Drug for Anxiety in Autism

Phase 2
Waitlist Available
Led By Christopher J Smith, Ph.D.
Research Sponsored by Southwest Autism Research & Resource Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Male or female age 18 to 45 years old with an autism diagnosis
Participant is ≥ 100 lbs
Must not have
Participant weighs < 100 lbs
Participant is sexually active and does not practice two effective forms of birth control
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Summary

This trial aims to study if a marijuana-based drug can help reduce anxiety in autistic adults. Participants will take the drug or a placebo for 8 weeks and keep a daily diary of their feelings. The

Who is the study for?
This trial is for adults with autism who experience anxiety. Participants should be willing to take a daily oral medication and keep a diary of their feelings. They must commit to regular checkups every two weeks. Specific inclusion and exclusion criteria details are not provided, but typically involve meeting diagnostic criteria for the conditions being studied.
What is being tested?
Researchers are testing MB-IMP, a marijuana-based compound high in CBD with some THC, against a placebo to see if it reduces anxiety symptoms in autistic adults. The study involves taking the substance daily for 8 weeks with regular follow-ups.
What are the potential side effects?
While specific side effects aren't listed here, common ones from similar compounds include drowsiness, dry mouth, changes in appetite or mood, and possible discomfort at higher doses of THC.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 45 years old and have been diagnosed with autism.
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I weigh at least 100 pounds.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I weigh less than 100 lbs.
Select...
I am sexually active and do not use two forms of birth control.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in baseline on reported anxiety related symptoms
Secondary study objectives
Change in repetitive behaviors from baseline to the end of study
Change in socialization
We will measure the change in a variety of aberrant behaviors from baseline to end of study

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: MB-IMP GroupActive Control1 Intervention
Participants in this group will receive the MB-IMP, an oil-based solution that will contain CBD and THC (23:1 ratio, respectively) and be taken orally. Participants or study partners will dispense the daily dose with an eye dropper according to instructions from the Principal Investigator or delegated study coordinator. Dosing will start at 0.25 ml per day (50 mg of CBD and 2.18 mg of THC). The dose will gradually increase to 1.0 ml per day (200 mg of CBD, and 8.7 mg of TCH) by week 4. Weeks 5 through 8 will be at the maximum dose, 2 ml per day (400 mg of CBD and 17.4 mg of THC). With the exception of week 1 at the lowest dose (0.25 ml), participants will dose in the morning and evening to reach the maximum dose for that time period.
Group II: Placebo GroupPlacebo Group1 Intervention
Participants will follow the same dosing instructions for the MB-IMP group, but will take only MCT oil.

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Who is running the clinical trial?

Southwest Autism Research & Resource CenterLead Sponsor
8 Previous Clinical Trials
878 Total Patients Enrolled
Christopher J Smith, Ph.D.Principal InvestigatorSARRC
~72 spots leftby Sep 2026
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