Investigating a Marijuana-based Compound as a Treatment for Anxiety in Autistic Adults
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
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
Treatments tested in this trial
- MB-IMP
- Placebo
Treatment groups
108 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov