Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526208
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-23
Brief Title:
Investigating a Marijuana-based Compound as a Treatment for Anxiety in Autistic Adults
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 2 Randomized Placebo-controlled Double-blind Parallel Study to Assess the Safety and Efficacy of an Oral Marijuana-Based Investigational Medical Product to Treat Anxiety in Adults With Autism Spectrum Disorder ASD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
The marijuana-based investigation medical product MB-IMP in this study is 23 parts CBD and 1 part THC The placebo is medium chain triglyceride oil MB-IMP or placebo will be taken orally DSM-5 diagnosis of autism spectrum disorder will be confirmed with Autism Diagnostic Observation Schedule version 2 and review of medical records History of psychosis suicidality cardiac or hepatocellular issues may be exclusionary The participant must have a study partner who will complete observational assessments regarding the participant39s behavior
The screening period is 3 weeks to allow for lab results and medical records to be obtained The active phase of the study on drug or placebo is 8 weeks and their will be one follow-up visit after 14 days off drug
The screening period is 3 weeks to allow for lab results and medical records to be obtained The active phase of the study on drug or placebo is 8 weeks and their will be one follow-up visit after 14 days off drug
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None