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

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)

Investigating a Marijuana-based Compound as a Treatment for Anxiety in Autistic Adults (NCT06526208) is a Phase 2 interventional studying Autism Spectrum Disorder and Anxiety, sponsored by Southwest Autism Research & Resource Center. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Autism Spectrum Disorder and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 108 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Autism Spectrum Disorder subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Male or female age 18 to 45 years old with an autism diagnosis. 2. Participant is ≥ 100 lbs. 3. Participant or a legally authorized representative provides willing to sign a consent form/assent for participation in the trial. 4. Participant/caregiver is willing and able to comply with all study procedures. 5. Participant meets ADOS-2 criteria for Autism or Autism Spectrum 6. Participant meets DSM-5 criteria for ASD. 7. Participant has a minimum CGI-S (Anxiety) score ≥ 5 based on anxiety related social functional impairment. 8. Participant has a FSIQ ≥ 65 at screening measured with the WASI- II, or within 1 year of screening with a comparable assessment. 9. 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. 10. 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 Study Termination visit. 11. 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 medication or psychotherapy treatment regimen during the study. 12. Participant must be able to ingest MB-IMP (or placebo) and be willing to commit to medication dosing and completing the dosing diary. 13. 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. 14. Participant agrees not to participate in any other interventional clinical trials during the study period. 15. Participant agrees to inform the investigators within 48- hours of any side-effects, medical conditions, and procedures. ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Male or female age 18 to 45 years old with an autism diagnosis. 2. Participant is ≥ 100 lbs. 3. Participant or a legally authorized representative provides informed consent/assent for participation in the trial. 4. Participant/caregiver is willing and able to comply with all study procedures. 5. Participant meets ADOS-2 criteria for Autism or Autism Spectrum 6. Participant meets DSM-5 criteria for ASD. 7. Participant has a minimum CGI-S (Anxiety) score ≥ 5 based on anxiety related social functional impairment. 8. Participant has a FSIQ ≥ 65 at screening measured with the WASI- II, or within 1 year of screening with a comparable assessment. 9. 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. 10. 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 Study Termination visit. 11. 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 medication or psychotherapy treatment regimen during the study. 12. Participant must be able to ingest MB-IMP (or placebo) and be willing to commit to medication dosing and completing the dosing diary. 13. 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. 14. Participant agrees not to participate in any other interventional clinical trials during the study period. 15. Participant agrees to inform the investigators within 48- hours of any side-effects, medical conditions, and procedures. 16. Participant agrees to abstain from alcohol use during the study. Exclusion Criteria: 1. Participant weighs \&amp;lt; 100 lbs. 2. Participant is sexually active and does not practice two effective forms of birth control. 3. Participant is pregnant, lactating, or planning pregnancy during the study period or within 12 weeks thereafter. 4. Participant has a current or historical psychotic features/disorder assessed via the Mini-International Neuropsychiatric Interview (MINI). 5. 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. 6. At high risk of suicide or suicide attempts. 1. 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. 2. History of suicide attempts within 12 months prior to study enrollment. 7. Participant has a current substance use disorder within the 12 months prior to enrollment as determined by the MINI Kid56. 8. 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 allowed to rescreen (maximum twice) after a 1-month cessation of cannabis use. 9. 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. 10. 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 been successfully treated with ablation and have not had a recurrent arrhythmia for at least one year off all antiarrhythmic drugs or are under adequate and stable pharmacologic treatment for atrial fibrillation for at least a year, as confirmed by a cardiologist. 11. Participant has a current diagnosis or evidence of significant or uncontrolled hematological, endocrine, cerebrovascular, cardiovascular, coronary, pulmonary, gastrointestinal, renal, immunocompromising, or neurological disease according to PI's discretion. 12. 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 times ULN. 13. The PI or medical monitor deems the participant inappropriate for the study for any reason. 14. Any known allergies/sensitivities to cannabis (in the opinion of the investigator). 15. Not able to attend required face-to-face visits or those who plan to move out of the area within the treatment period.

Treatments Being Tested

DRUG

MB-IMP

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.

OTHER

Placebo

Does not contain CBD or THC

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Southwest Autism Research and Resource Center

Phoenix, Arizona, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06526208), the sponsor (Southwest Autism Research & Resource Center), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06526208 clinical trial studying?

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… The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06526208?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06526208?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06526208. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06526208. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.