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Autism Spectrum DisorderPhase 2NCT06526208

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

A Phase 2 study testing MB-IMP in people with Autism Spectrum Disorder and Anxiety, run by Southwest Autism Research & Resource Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 45 years
Conditions the study is for
Autism Spectrum Disorder, Anxiety
What is being tested?
MB-IMP
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
108 participants
Where
1 siteUnited States
Study dates
28 May 2025to 30 Sep 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.
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  • 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 Study Termination visit.
  • 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.
  • 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 interventional 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.

Who cannot join

  • 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.
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  • 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 allowed to rescreen (maximum twice) after a 1-month cessation of cannabis use.
  • 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 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.
  • 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.
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Christopher J Smith, Ph.D. contact

602-218-8192

csmith@autismcenter.org

Brian Shaw contact

602-340-8717

bshaw@autismcenter.org

United States1 site, 1 recruiting

  • Southwest Autism Research and Resource Center

    Phoenix, Arizona, 85006

    Christopher J Smith, Ph.D., 602-218-8192, csmith@autismcenter.org

    Brian Shaw, 602-340-8717, bshaw@autismcenter.org

    Recruiting

Other trials in United States

About this study

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)

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?

Read more

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.

Read the 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 participant\'s 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.

Being tested
MB-IMP, Placebo
Keywords
Autism, Anxiety, marijuana, cannabis, CBD, THC
Medical subject headings
Autism Spectrum Disorder, Anxiety Disorders, Autistic Disorder, Marijuana Abuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MB-IMPDrug

    Also called MCT oil

    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.

  • PlaceboOther

    Also called Medium Chain Triglyceride (MCT) oil

    Does not contain CBD or THC

Study groups in NCT06526208
Study groupRoleWhat they receive
MB-IMP GroupActive comparatorParticipants in this group will receive the MB-IMP, an oil-based solution that will contain CBD and THC (23:1 ratio, respectively) and be taken orally. Participants or study partners will dispense the daily dose with an eye dropper according to instructions from the Principal Investigator or delegated study coordinator. Dosing will start at 0.25 ml per day (50 mg of CBD and 2.18 mg of THC). The dose will gradually increase to 1.0 ml per day (200 mg of CBD, and 8.7 mg of TCH) by week 4. Weeks 5 through 8 will be at the maximum dose, 2 ml per day (400 mg of CBD and 17.4 mg of THC). With the exception of week 1 at the lowest dose (0.25 ml), participants will dose in the morning and evening to reach the maximum dose for that time period.
Receives: Drug: MB-IMP
Placebo GroupPlacebo comparatorParticipants will follow the same dosing instructions for the MB-IMP group, but will take only MCT oil.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in baseline on reported anxiety related symptoms

    The Clinical Global Impression Scale for Severity will be used to measure the change in anxiety related symptoms. We hypothesize a two point reduction in severity and

    Measured: 8 weeks

Secondary outcomes (3)

  1. Change in socialization

    We will measure the Change in behaviors related to socialization with the Social Responsiveness Scale

    Measured: 8 weeks

  2. Change in repetitive behaviors from baseline to the end of study

    We will measure the amount of repetitive behaviors with the Repetitive Behavior Scale- Revised

    Measured: 8 weeks.

  3. We will measure the change in a variety of aberrant behaviors from baseline to end of study

    Study partners will complete the Aberrant Behavior Checklist at every clinic visit.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jul 2024
  2. Study start28 May 2025
  3. Primary completion30 Sep 2026 (estimated)
  4. Study completion30 Sep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
108 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06526208
Sponsor's protocol ID
168788
Other IDs
RFGA2022-009-001
Status last verified
Mar 2026
First submitted
23 Jul 2024
Last updated
30 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MB-IMP in people with Autism Spectrum Disorder and Anxiety, run by Southwest Autism Research & Resource Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Christopher J Smith, Ph.D. (602-218-8192, csmith@autismcenter.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in baseline on reported anxiety related symptoms (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06526208.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.

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