Health TrialsbyHealthPanel

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

ConditionsAutism Spectrum DisorderAnxiety
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-45
SponsorSouthwest Autism Research & Resource Center

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Male or female age 18 to 45 years old with an autism diagnosis.

Participant is ≥ 100 lbs.

Participant or a legally authorized representative provides informed consent/assent for participation in the trial.

Participant/caregiver is willing and able to comply with all study procedures.

Disqualifiers

Participant weighs < 100 lbs.

Participant is sexually active and does not practice two effective forms of birth control.

Participant is pregnant, lactating, or planning pregnancy during the study period or within 12 weeks thereafter.

Participant has a current or historical psychotic features/disorder assessed via the Mini-International Neuropsychiatric Interview (MINI).

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

    Does not contain CBD or THC

Treatment groups

108 Participants
are divided into 2 treatment groups
Group A: MB-IMP GroupActive comparator 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in baseline on reported anxiety related symptoms

The Clinical Global Impression Scale for Severity will be used to measure the change in anxiety related symptoms. We hypothesize a two point reduction in severity and

Time frame
8 weeks

Secondary outcomes

1

Change in socialization

We will measure the Change in behaviors related to socialization with the Social Responsiveness Scale

Time frame
8 weeks
2

Change in repetitive behaviors from baseline to the end of study

We will measure the amount of repetitive behaviors with the Repetitive Behavior Scale- Revised

Time frame
8 weeks.
3

We will measure the change in a variety of aberrant behaviors from baseline to end of study

Study partners will complete the Aberrant Behavior Checklist at every clinic visit.

Time frame
8 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Southwest Autism Research & Resource Center

Lead sponsor

Source ClinicalTrials.gov
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