Marijuana-based Drug for Anxiety in Autism

Overseen By Brian Shaw

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: Southwest Autism Research & Resource Center

Must not be taking: Opiates, Methamphetamine, Cocaine, others

Disqualifiers: Psychotic disorder, Substance use, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

108 Participants Needed

Trial Summary

Do I have to stop taking my current medications to join the trial?

No, you don't have to stop taking your current medications. You must be stable on them for 6 weeks before joining the study and agree to keep the same treatment during the trial.

What data supports the effectiveness of the marijuana-based drug MB-IMP for anxiety in autism?

Research shows that cannabis extracts, particularly those rich in cannabidiol (CBD), have helped improve symptoms in autism, including anxiety, with mild side effects. Studies indicate that CBD-enriched treatments can enhance quality of life and reduce other medications in autistic patients. ^{1 2 3 4 5}

Is the marijuana-based drug for anxiety in autism safe for humans?

Some studies suggest that cannabis-based treatments for autism may have mild and infrequent side effects, but there are reports of serious effects like mania or psychosis in some individuals. More large-scale studies are needed to confirm safety. ^{1 2 5 6 7}

How does the marijuana-based drug MB-IMP differ from other treatments for anxiety in autism?

MB-IMP is unique because it uses a marijuana-based approach, potentially involving components like cannabidiol (CBD) and tetrahydrocannabinol (THC), which are adjusted individually based on patient response. This personalized dosage regimen aims to improve core and comorbid symptoms of autism with minimal side effects, unlike standard treatments that may not be as tailored or effective for these symptoms. ^{1 2 3 5 8}

What is the purpose of 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.

Research Team

Christopher J Smith, Ph.D.

Principal Investigator

SARRC

Eligibility Criteria

This trial is for adults with autism who experience anxiety. Participants should be willing to take a daily oral medication and keep a diary of their feelings. They must commit to regular checkups every two weeks. Specific inclusion and exclusion criteria details are not provided, but typically involve meeting diagnostic criteria for the conditions being studied.

Inclusion Criteria

Participant meets DSM-5 criteria for ASD

I can take oral medication and am willing to follow the dosing schedule and keep a diary.

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

Exclusion Criteria

I weigh less than 100 lbs.

I am sexually active and do not use two forms of birth control.

Participant is pregnant, lactating, or planning pregnancy during the study period or within 12 weeks thereafter

Timeline

Screening

Participants are screened for eligibility to participate in the trial

3 weeks

Treatment

Participants receive either the marijuana-based investigational medical product or placebo orally for anxiety treatment

8 weeks

Weekly phone or clinic visits, clinic visits every 2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 follow-up visit

Treatment Details

Interventions

• MB-IMP

Trial Overview Researchers are testing MB-IMP, a marijuana-based compound high in CBD with some THC, against a placebo to see if it reduces anxiety symptoms in autistic adults. The study involves taking the substance daily for 8 weeks with regular follow-ups.

Participant Groups

Group I: MB-IMP Group Active Control 1 Intervention

Participants 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.

Group II: Placebo Group Placebo Group 1 Intervention

Participants will follow the same dosing instructions for the MB-IMP group, but will take only MCT oil.

Who Is Running the Clinical Trial?

Southwest Autism Research & Resource Center

Lead Sponsor

Trials

9

Recruited

950+

Findings from Research

In a study of 20 patients with Autism Spectrum Disorders treated with full-spectrum cannabis extracts (FCEs) for at least 6 months, 90% showed improvement in core and comorbid symptoms, as well as quality of life, with only mild and infrequent side effects reported.

The study also found that FCEs could effectively treat allotriophagy (Pica), and many patients were able to reduce or discontinue other medications, suggesting a potential for tailored cannabis-based therapies in managing ASD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individually tailored dosage regimen of full-spectrum Cannabis extracts for autistic core and comorbid symptoms: a real-life report of multi-symptomatic benefits. Montagner, PSS., Medeiros, W., da Silva, LCR., et al.[2023]

In an observational study of 18 autistic patients treated with a CBD-enriched Cannabis sativa extract, most showed significant improvements in various symptoms of Autism Spectrum Disorders after 6-9 months, particularly in areas like seizures, attention deficit/hyperactivity disorder, and communication.

Despite some patients experiencing mild adverse effects leading to discontinuation, the majority of those who adhered to the treatment reported improvements, with many able to reduce or stop other medications while maintaining these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of CBD-Enriched Cannabis sativa Extract on Autism Spectrum Disorder Symptoms: An Observational Study of 18 Participants Undergoing Compassionate Use. Fleury-Teixeira, P., Caixeta, FV., Ramires da Silva, LC., et al.[2020]

Current research indicates that cannabis and cannabidiol may offer potential therapeutic benefits for some individuals with autism spectrum disorder (ASD), particularly for associated noncore symptoms and comorbidities.

The available data suggest that these treatments are generally well tolerated, but further studies are needed to identify which patients might benefit the most and to ensure safety without adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autism Spectrum Disorder and Medical Cannabis: Review and Clinical Experience. Mostafavi, M., Gaitanis, J.[2021]

In a study involving 34 healthy men (17 with autism spectrum disorder and 17 without), the compound cannabidivarin (CBDV) was found to significantly increase levels of glutamate and glutamine (Glx) in the basal ganglia, indicating its potential to modulate brain excitatory-inhibitory systems relevant to autism.

The response to CBDV varied among individuals, particularly in the ASD group, where changes in Glx levels were negatively correlated with baseline concentrations, suggesting that individual biochemistry may influence the effectiveness of CBDV as a treatment for autism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of cannabidivarin (CBDV) on brain excitation and inhibition systems in adults with and without Autism Spectrum Disorder (ASD): a single dose trial during magnetic resonance spectroscopy. Pretzsch, CM., Voinescu, B., Lythgoe, D., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Individually tailored dosage regimen of full-spectrum Cannabis extracts for autistic core and comorbid symptoms: a real-life report of multi-symptomatic benefits. [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of CBD-Enriched Cannabis sativa Extract on Autism Spectrum Disorder Symptoms: An Observational Study of 18 Participants Undergoing Compassionate Use. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Autism Spectrum Disorder and Medical Cannabis: Review and Clinical Experience. [2021]

4. Singapore pubmed.ncbi.nlm.nih.gov

Autism and associated disorders: cannabis as a potential therapy. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Efficacy of cannabinoids in neurodevelopmental and neuropsychiatric disorders among children and adolescents: a systematic review. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Brief Report: Suspected Cannabis-Induced Mania and Psychosis in Young Adult Males with Autism Spectrum Disorder. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Clinical outcome analysis of patients with autism spectrum disorder: analysis from the UK Medical Cannabis Registry. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Effects of cannabidivarin (CBDV) on brain excitation and inhibition systems in adults with and without Autism Spectrum Disorder (ASD): a single dose trial during magnetic resonance spectroscopy. [2021]