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

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Southwest Autism Research & Resource Center
Study ID
NCT06526208
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • MB-IMP — DRUG
    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.
  • Placebo — OTHER
    Does not contain CBD or THC

Study Details

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.

Key Dates

Start date
May 28, 2025
Status verified
Mar 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
108 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: MB-IMP Group
    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.
  • Placebo Comparator: Placebo Group
    Participants will follow the same dosing instructions for the MB-IMP group, but will take only MCT oil.

Primary Outcome Measure

Change in baseline on reported anxiety related symptoms [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Southwest Autism Research and Resource CenterPhoenixArizona85006
Christopher J Smith, Ph.D.
[email protected]
602-218-8192
Brian Shaw
[email protected]
602-340-8717
Christopher J Smith, Ph.D. (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By condition
Autism spectrum disorder
By specialty
Pediatrics
By research site
Southwest Autism Research and Resource Center· Phoenix, AZ

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