Phase 2 Autism Spectrum Disorder Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• Adults aged 18 to 45 who have been diagnosed with autism.
• People who weigh at least 100 lbs.
• People (or their legal representative) who are able and willing to give formal written consent to take part in the trial.
• People whose caregiver (if applicable) is willing and able to follow all study procedures throughout the trial.
• People whose autism diagnosis has been confirmed using a specific standardised assessment tool called the ADOS-2.
• People whose autism diagnosis meets the current standard diagnostic guidelines (DSM-5 criteria for ASD).
• People who have a moderate-to-severe level of anxiety-related social difficulties, as measured by a specific rating scale (CGI-S score of 5 or higher).
• People with a general intelligence score (Full Scale IQ) of 65 or above, measured by a specific test (WASI-II) either at the start of the trial or within the past year using a comparable assessment.
• People who test negative for pregnancy at the start of the trial and at scheduled points throughout (confirm with trial site for full testing schedule).
• Sexually active people who agree to use two forms of effective contraception during the trial and for at least 14 days after the final study visit.
• People who have been on a stable dose of any existing medications and/or psychotherapy for at least 6 weeks before joining, who agree to let their prescribing doctor know about their participation, and who agree to keep their current treatment regimen unchanged during the study.
• People who are able to swallow the study medication (or placebo) and are willing to take it as directed and keep a dosing diary.
• People (or their caregiver) who agree to store the study medication safely at home and not share it with anyone else.
• People who agree not to take part in any other interventional clinical trials at the same time.
• People who agree to inform the research team within 48 hours of any side effects, new medical conditions, or medical procedures.
• People who agree to avoid alcohol for the entire duration of the study.

Who may not be able to join:

• People who weigh less than 100 lbs.
• Sexually active people who do not use two effective forms of contraception.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study or within 12 weeks after it ends.
• People who have a current or past history of psychotic symptoms or a psychotic disorder, as assessed through a specific psychiatric interview tool (MINI).
• People who have a current or past diagnosis of dissociative identity disorder, or who have a close family member (parent or sibling) with a history of a psychotic disorder or bipolar disorder type 1.
• People who are considered at high risk of suicide, including those assessed as having a serious current suicide risk or who have attempted suicide in the 12 months before enrolling.
• People who have had a substance use disorder in the 12 months before enrolling, as assessed through a specific interview tool.
• People whose urine drug test at screening is positive for opioids, methamphetamine, cocaine, cannabis (THC), or amphetamines — unless those substances were prescribed by a doctor. People who test positive for cannabis may be able to rescreen (up to two times) after stopping cannabis use for at least one month.
• People who have a history of irregular heart rhythms (arrhythmia) — other than occasional minor irregular beats — in the 12 months before screening, unless specific treatment conditions have been met (confirm with trial site for details on exceptions).
• People with a history of certain specific heart rhythm disorders (such as atrial fibrillation, atrial flutter, or related conditions) may not be eligible unless they have been successfully treated and have had no recurrence for at least one year, as confirmed by a heart specialist (confirm with trial site for full details).
• People who have a current diagnosis of, or evidence of significant or poorly controlled conditions affecting the blood, hormones, brain, heart, blood vessels, lungs, digestive system, kidneys, immune system, or nervous system, as assessed by the study doctor.
• People who have blood test results showing significant liver damage (specifically elevated liver enzyme and bilirubin levels above defined thresholds).
• People whom the lead study doctor or medical monitor considers unsuitable for the trial for any reason.
• People with known allergies or sensitivities to cannabis.
• People who are unable to attend required in-person visits, or who plan to move out of the study area before the treatment period ends.

Important: Always verify eligibility with the trial site directly before applying.