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New treatment option for Autism Spectrum Disorder
Official title Investigating a Marijuana-based Compound as a Treatment for Anxiety in Autistic Adults
ClinicalTrials.gov ID: NCT06526208
What this study is testing
What is MB-IMP?
MB-IMP is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for autism spectrum disorder.
Also referred to as MCT oil.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45
You may be able to join if
- 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.
- Participant meets ADOS-2 criteria for Autism or Autism Spectrum
You likely can't join if
- 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).
- Participant has a current or historical DSM-5 diagnosis of dissociative identity disorder, positive family history (first-degree relative) of...
- At high risk of suicide or suicide attempts.
See the full eligibility criteria
- 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.
- Participant meets ADOS-2 criteria for Autism or Autism Spectrum
- Participant meets DSM-5 criteria for ASD.
- Participant has a minimum CGI-S (Anxiety) score ≥ 5 based on anxiety related social functional impairment.
- Participant has a FSIQ ≥ 65 at screening measured with the WASI- II, or within 1 year of screening with a comparable assessment.
- Participant must have a negative pregnancy test (urine and serum) at Screening, and a negative urine test at Baseline, Active Phase Visits, and EoS visits, see Table 1. Schedule of Activities.
- Sexually active participants agree to use two methods of effective birth control, as described in Appendix B: Contraceptive and Barrier Guidance during the study intervention period and for at least 14 days after the...
- Participant must be stable on any pre-study medications and/or psychotherapy for 6-weeks prior to study enrollment, agree to inform prescribing clinician(s) about participation in the study, and agree to maintain...
- Participant must be able to ingest MB-IMP (or placebo) and be willing to commit to medication dosing and completing the dosing diary.
- Participant/caregiver agrees to keep all study medication provided by site staff securely stored at home and not to share/distribute study medication to any other individual.
- Participant agrees not to participate in any other treatment clinical trials during the study period.
- Participant agrees to inform the investigators within 48- hours of any side-effects, medical conditions, and procedures.
- Participant agrees to abstain from alcohol use during the study.
- 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).
- Participant has a current or historical DSM-5 diagnosis of dissociative identity disorder, positive family history (first-degree relative) of psychotic disorder or bipolar disorder type 1.
- At high risk of suicide or suicide attempts.
- Individuals presenting current serious suicide risk, as determined through psychiatric interview, responses to the Columbia Suicide Severity Rating Scale (C-SSRS), and/or clinical judgment of the investigator.
- History of suicide attempts within 12 months prior to study enrollment.
- Participant has a current substance use disorder within the 12 months prior to enrollment as determined by the MINI Kid56.
- Participant's urine drug screen is positive for opiates, methamphetamine, cocaine, THC, and amphetamines (unless prescribed). Participants with positive THC urine analysis tests are excluded from the study but will be...
- Participant has a history of arrhythmia, other than occasional premature atrial contractions (PACs) and premature ventricular contractions (PVCs) without ischemic heart disease, within 12 months of screening.
- Participant with a history of atrial fibrillation, atrial tachycardia, atrial flutter or paroxysmal supraventricular tachycardia, or any other arrhythmia associated with a bypass tract, may be enrolled only if they have...
- Participant has a current diagnosis or evidence of significant or uncontrolled hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal, renal, immunocompromising, or neurological...
- Evidence of existing hepatocellular injury defined as alanine transaminase (ALT) and aspertate aminotranferase (AST) elevations of greater than 3 times upper limit normal (ULN) and bilirubin elevation of greater than 2...
- The PI or medical monitor deems the participant inappropriate for the study for any reason.
- Any known allergies/sensitivities to cannabis (in the opinion of the investigator).
- Not able to attend required face-to-face visits or those who plan to move out of the area within the treatment period.
The study team makes the final eligibility decision.
Where it's taking place
- Phoenix, Arizona, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 45 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Phoenix, Arizona, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.