Cannabinoid treatment for autism: a proof-of-concept randomized trial
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BACKGROUND: Endocannabinoid dysfunction in animal models of autism spectrum disorder (ASD) and accumulating, albeit anecdotal, evidence for efficacy in humans motivated this placebo-controlled double-blind comparison of two oral cannabinoid solutions in 150 participants (age 5-21 years) with ASD. METHODS: We tested (1) BOL-DP-O-01-W, a whole-plant cannabis extract containing cannabidiol and Δ9-tetrahydrocannabinol at a 20:1 ratio and (2) BOL-DP-O-01, purified cannabidiol and Δ9-tetrahydrocannabinol at the same ratio. Participants (N = 150) received either placebo or cannabinoids for 12-weeks (testing efficacy) followed by a 4-week washout and predetermined cross-over for another 12 weeks to further assess tolerability. Registered primary efficacy outcome measures were improvement in behavioral problems (differences between whole-plant extract and placebo) on the Home Situation Questionnaire-ASD (HSQ-ASD) and the Clinical Global Impression-Improvement scale with disruptive behavior anchor points (CGI-I). Secondary measures were Social Responsiveness Scale (SRS-2) and Autism Parenting Stress Index (APSI). RESULTS: Changes in Total Scores of HSQ-ASD (primary-outcome) and APSI (secondary-outcome) did not differ among groups. Disruptive behavior on the CGI-I (co-primary outcome) was either much or very much improved in 49% on whole-plant extract (n = 45) versus 21% on placebo (n = 47; p = 0.005). Median SRS Total Score (secondary-outcome) improved by 14.9 on whole-plant extract (n = 34) versus 3.6 points after placebo (n = 36); p = 0.009). There were no treatment-related serious adverse events. Common adverse events included somnolence and decreased appetite, reported for 28% and 25% on whole-plant extract, respectively (n = 95); 23% and 21% on pure-cannabinoids (n = 93), and 8% and 15% on placebo (n = 94). Limitations Lack of pharmacokinetic data and a wide range of ages and functional levels among participants warrant caution when interpreting the results. CONCLUSIONS: This interventional study provides evidence that BOL-DP-O-01-W and BOL-DP-O-01, administrated for 3 months, are well tolerated. Evidence for efficacy of these interventions are mixed and insufficient. Further testing of cannabinoids in ASD is recommended. Trial registration ClinicalTrials.gov: NCT02956226. Registered 06 November 2016, https://clinicaltrials.gov/ct2/show/NCT02956226.
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A recent randomized controlled trial of an oral preparation of CBD in children and young adults with ASD demonstrated positive improvements in behavior and social communication with CBD.
“Another recent randomized controlled trial (RCT) looking at an oral preparation of CBD in children and young adults with ASD demonstrated positive improvements in behavior and social communication with CBD [125].”
From An Update on Psychopharmacological Treatment of Autism Spectrum Disorder (2022) · cites this paper as [125]
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An Update on Psychopharmacological Treatment of Autism Spectrum Disorder
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Clinical Data on Canabinoids: Translational Research in the Treatment of Autism Spectrum Disorders
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Augmentation of Endogenous 2-Arachidonoylglycerol Mitigates Autistic Behaviors of BTBR Mice
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- Authors
- Aran, A., Harel, M., Cassuto, H., Polyansky, L., Schnapp, A., Wattad, N., Shmueli, D., Golan, D., & Castellanos, F. X.
- Affiliations
- Shaare Zedek Medical Center (IL)
- Clalit Health Services (IL)
- Maccabi Healthcare Services (IL)
- New York University (US)
- Corresponding author
- Aran, Adi
- Venue
- Molecular Autism
- Published
- 2021-02-03
- Volume
- 12
- Issue
- 1
- Pages
- 6-6
- ISSN
- 2040-2392 (ISSN-L)
- PMC
- PMC7860205
- OpenAlex
- W3126959679
- Cited by
- 223
- References
- 43
- Citations by year
- 2026: 21 · 2025: 63 · 2024: 53 · 2023: 30 · 2022: 42 · 2021: 14
- FWCI
- 20.29
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- Molecular Autism (publishedVersion, cc-by)
- Europe PMC (PubMed Central) (publishedVersion, other-oa)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- Funders
- BOL Pharma, Revadim, Israel
- National Institute for Psychobiology in Israel, Hebrew University of Jerusalem (203-17-18)
- Topics
- Health Sciences › Medicine › Pharmacology › Cannabis and Cannabinoid Research
- Life Sciences › Neuroscience › Cognitive Neuroscience › Autism Spectrum Disorder Research
- Health Sciences › Medicine › Psychiatry and Mental health › Child Nutrition and Feeding Issues
- Keywords
- autism spectrum disorder, cannabinoids, cannabidiol, tetrahydrocannabinol, disruptive behavior, social responsiveness, parental stress, treatment tolerability, adverse events, sleepiness, appetite suppression, crossover design, Social Responsiveness Scale
- MeSH terms
- Autism Spectrum Disorder, Adolescent, Adult, Autistic Disorder, Cannabinoids, Child, Child, Preschool, Female, Humans, Male, Social Behavior, Treatment Outcome, Young Adult
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