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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a marijuana-based drug (MB-IMP) can reduce anxiety in autistic adults, potentially making socializing and working easier. Participants will take either the drug, which mainly contains CBD with a little THC, or a placebo daily for eight weeks. The trial aims to determine the drug's safety and effectiveness in easing anxiety symptoms. Individuals diagnosed with autism who experience severe anxiety affecting social functioning might be suitable candidates for participation. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important early findings.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that CBD-rich medical cannabis can help with symptoms related to autism spectrum disorder (ASD) and is usually well-tolerated. One study found that many users experienced improvement with only a few side effects. However, the long-term safety of these treatments remains unclear.

This trial involves a specific cannabis-based drug called MB-IMP, primarily composed of CBD with a small amount of THC. THC is the component of cannabis that can cause a "high." The trial aims to determine if this combination is safe and effective for reducing anxiety in autistic adults. Participants will begin with a low dose, gradually increasing it to assess their tolerance to the treatment.

While earlier studies suggest that CBD is generally safe, individual reactions may vary. This trial will provide more detailed information on safety for this specific group. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for anxiety in autism, which often involve medications like SSRIs or behavioral therapies, MB-IMP is derived from marijuana, specifically using a combination of CBD and THC. Researchers are particularly excited about this treatment because it targets the endocannabinoid system, which is not the focus of most conventional anxiety medications. Additionally, the unique delivery method of MB-IMP, using an oral oil-based solution, allows for precise dosing adjustments, potentially leading to more personalized and effective management of anxiety symptoms.

What evidence suggests that this marijuana-based drug is effective for anxiety in autism?

Research has shown that cannabis-based treatments may help with autism symptoms. In one study, 90% of individuals with Autism Spectrum Disorders who used full-spectrum cannabis extracts for six months showed improvement. Another study found that about 68% of patients experienced fewer outbursts and less self-injury after using cannabis. Additionally, some countries have successfully used CBD-rich products to manage autism symptoms. In this trial, participants in the MB-IMP group will receive a marijuana-based drug containing CBD and a small amount of THC, which could help reduce anxiety in autistic adults. ^{1 2 3 5 6}

Who Is on the Research Team?

Christopher J Smith, Ph.D.

Principal Investigator

SARRC

Are You a Good Fit for This Trial?

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

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

Participant meets DSM-5 criteria for ASD

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

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)

I weigh less than 100 lbs.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. withpower.com withpower.com/trial/phase-2-anxiety-9-2024-32520

Marijuana-based Drug for Anxiety in Autism 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9418362/

Safety and Efficacy of Medical Cannabis in Autism Spectrum ... Outbursts and self-injury were experienced by 34 patients at study initiation and were found to be improved in 67.6%, no change in 23.5%, and worsened in 8.8% ...

3. accp1.onlinelibrary.wiley.com accp1.onlinelibrary.wiley.com/doi/full/10.1002/jcph.70068

Therapeutic Use of Cannabis Derivatives and Their Analogs ... Studies have found promising results regarding the effects of cannabis on autism. We conducted a systematic review of randomized clinical trials ...

4. lrl.mn.gov lrl.mn.gov/archive/minutes/senate/2023/health/20230221/Health_20230221_KaylaFearing-SF73-Letter.pdf

Austism Spectrum Disorder, and Benefits of Cannabis Use: Cannabidiol (CBD) rich products are successfully used in some countries for treating symptoms associated with autism spectrum disorder (ASD).

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05212493

The Effects of Medical Cannabis in Children With Autistic ... The aim of this study is to investigate if oral cannabinoids treatment to children and young adults with ASD affect the comorbidities of autism.

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0006160

Autism Spectrum Disorder (DBCOND0006160) A Clinical Trial of a New Computer Based Intervention for Children With Autism. No drug interventions, treatment, 0, completed. NCT05509309. Promoting Inclusive ...