Petitions

Dec 29, 2017 | Uncategorized

LARA has approved 11 conditions to be added to the Michigan Medical Marijuana Act.

The following conditions were approved by Edgerton after a majority of the Medical Marihuana Review Panel members recommended approval:

• Arthritis
• Autism
• Chronic Pain
• Colitis
• Inflammatory Bowel Disease
• Obsessive Compulsive Disorder
• Parkinson’s
• Rheumatoid Arthritis
• Spinal Cord Injury
• Tourette’s Syndrome
• Ulcerative Colitis

https://www.michigan.gov/lara/0,4601,7-154-79571_79784-472399–,00.html

After the MMMA was enacted by a vote of 63% of Michigan voters in 2008, the legislature has declined to add any new qualifying conditions to protect patients from arrest.

Senator Rick Jones even attempted to remove Glaucoma from the MMMP’s list of qualifying conditions. Patients , caregivers and other interested parties wrote in opposition to the bill.

A handful of petitions have been submitted over the years. LARA (and the previous MDCH department) have used various reasons and tricks to deny these petitions. Only Post Traumatic Stress Disorder has been added as a qualifying condition to the Michigan Medical Marihuana Act. Autism and Parkinson’s disorder petitions were approved by the Michigan medical marihuana review board (the board consists mostly of physicians). These petitions were denied by the LARA director. The petitions were not deficient in any way and should have been accepted by LARA. We resubmitted the Autism petition again, with 20 additional research studies.

Now, with the help of numerous patients, researchers, Dwight Z. and Dr. Christian Bogner along with the Michigan Medical Marijuana Association and Michael Komorn, we have assembled a massive amount of peer-reviewed medical research and government data to show that these conditions should be approved to protect patients, caregivers and physicians from arrest for the medical use of marijuana to treat their conditions.

This project took months of work. Reading, organizing, searching and collecting thousands of pages of research from all over the world. Including the most up to date medical studies, peer-reviewed patient surveys and the national reviews of all medical marijuana studies by the National Academies of Science. The oldest peer-reviewed medical research paper cited within these petitions was from the first volume of The Lancet in 1889. Birch EA. The use of Indian hemp in the treatment of chronic chloral and chronic opium poisoning. The Lancet. 1889;133:625.

Cannabis, Indian Hemp, Marijuana, whatever you call it, physicians were using this non-toxic plant in 1889 to treat chronic opium poisoning and opium addiction. As opioid based prescriptions are addicting and killing approximately 142 Americans each day in 2017, medical marijuana is a non-lethal non-toxic way to avoid “America enduring a death toll equal to September 11th every three weeks.”

The qualifying condition petitions were based primarily on the following:

• Already approved qualifying conditions in other medical marijuana states.
• Historical and ancient medical books.
• Patient self-reports and surveys.
• US Government Department of Health and Human Services Patent on using marijuana to treat many diseases and injuries, including brain injury on humans.
• Institute of Medicine 1999 report on medical marijuana. This report was the basis for the MMMA, specifically cited within the Michigan law, MCL 333.26422 (b).
• National Academies of Science (formerly the Institute of Medicine) 2017 updated report on medical marijuana.

Included research not only supports each qualifying condition petition, but also answers questions that the LARA directors, physicians and medical marijuana review panel board members had asked of past petitioners. Reports on dosages, safety profiles of marijuana, statistics from the CDC and Poison Control, and information from NIH, FDA and the DEA are presented in the petitions. This information was included in order to compare the safety, effects and side-effects of medical marijuana with FDA approved prescription medications.

All of the patients, caregivers, researchers, the Michigan Medical Marijuana Association and it’s president Michael Komorn fully agree that marijuana should be removed from the Controlled Substances Act. Marijuana should continue to be studied as a treatment for every human and animal disease. Marijuana also should be submitted to the FDA for approval as a medicine. We fully support all clinical trials related to using marijuana as a treatment for any condition, disease or injury. As all of the scientific peer-reviewed published clinical trials show, marijuana is an effective medicine.

The http://www.nih.gov website was heavily utilized throughout this project for locating scientific peer-reviewed published research, reports and information.

The petitions are grouped by similar conditions, symptoms or mechanisms of treatment. Included in this post are some choice quotes from a few studies in each group of petitions. We submitted 115 petitions, 22 were accepted as “complete”.

001.-Anxiety.pdf
004.-depression.pdf
007.-Obsessive-compulsive-disorder.pdf
008.-panic-attacks.pdf
011.-Schizophrenia.pdf
012.-Social-Anxiety-Disorder.pdf

Marijuana and Medicine Assessing the Science Base 1999 report from the Institute of Medicine

Quote

Movement disorders are a group of neurological conditions caused by abnormalities in
the basal ganglia and their subcortical connections through the thalamus with cortical
motor areas. The brain dysfunctions ultimately result in abnormal skeletal muscle
movements in the face, limbs, and trunk. The movement disorders most often considered
for marijuana or cannabinoid therapy are dystonia, Huntington’s disease, Parkinson’s
disease, and Tourette’s syndrome. Movement disorders are often transiently exacerbated
by stress and activity and improved by factors that reduce stress. This is of particular
interest because for many people marijuana reduces anxiety. 

https://directorsblog.nih.gov/2014/04/10/anxiety-reduction-exploring-the-role-of-cannabinoid-receptors/ 

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Relief of anxiety and stress is one of the most common reasons that people give for using marijuana

Medical Cannabis in Arizona: Patient Characteristics, Perceptions, and Impressions of Medical Cannabis Legalization.

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367 medical marijuana patients in Arizona were surveyed.
181 patients reported using medical marijuana to experience relief from Anxiety
164 patients reported using medical marijuana to experience relief from Stress.
General relief from Anxiety symptoms was 82.9% and 87.2% for Stress with medical marijuana,
Relief by medical marijuana compared to other medications was 79.3% for Anxiety and 91.6% for Stress.
Less frequent use of other medications was 85.9% for Anxiety and 79.1% for Stress.

32 patients reported using medical marijuana to experience relief from Attention-deficit/hyperactivity disorder.
General relief from ADHD symptoms was 81.2% with medical marijuana.
Relief by medical marijuana compared to other medications was 65% for ADHD.
Less frequent use of other medications was 84% for ADHD

23 patients reported using medical marijuana to experience relief from Bipolar disorder.
General relief from Bipolar disorder symptoms was 60% with medical marijuana.
Relief by medical marijuana compared to other medications was 90% for Bipolar disorder.
Less frequent use of other medications was 56% for Bipolar Disorder.

106 patients reported using medical marijuana to experience relief from Depression.
General relief from Depression symptoms was 82% with medical marijuana.
Relief by medical marijuana compared to other medications was 86.9% for Depression.
Less frequent use of other medications was 65% for Depression.

17 patients reported using medical marijuana to experience relief from Obsessive Compulsive Disorder..
General relief from OCD symptoms was 64.7% with medical marijuana.
Relief by medical marijuana compared to other medications was 62% for OCD.
Less frequent use of other medications was 33.4% for OCD.

2 patients reported using medical marijuana to experience relief from Schizophrenia.
General relief from Schizophrenia symptoms was 100% with medical marijuana.
Relief by medical marijuana compared to other medications was 100% for Schizophrenia.

28 patients reported using medical marijuana to experience relief from Post Traumatic Stress Disorder.
General relief from PTSD symptoms was 67.9% with medical marijuana.
Relief by medical marijuana compared to other medications was 92% for PTSD.
Less frequent use of other medications was 44.4% for PTSD.

014.-arthritis.pdf
023.-Rheumatoid-Arthritis.pdf

Quote

• Arkansas lists severe arthritis as a qualifying condition.
• California lists arthritis as a qualifying condition.
• Connecticut lists psoriatic arthritis as a qualifying condition.
• Illinois lists rheumatoid arthritis and Lupus as qualifying conditions.
• Hawaii lists rheumatoid arthritis and Lupus as qualifying conditions.
• New Hampshire lists Lupus as a qualifying condition.
• New Mexico lists inflammatory autoimmune-mediated arthritis as a qualifying condition.

 

Preliminary assessment of the efficacy, tolerability and safety of a cannabis-based medicine (Sativex) inthe treatment of pain caused by rheumatoid arthritis

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Statistically significant improvements in pain on movement, pain at rest, quality of sleep, DAS28 and the SF-MPQ pain at present component were seen following CBM ( cannabis based medicine ) in comparison with placebo.

Transdermal cannabidiol reduces inflammation and pain-related behaviours in a rat model of arthritis

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These data indicate that topical CBD application has therapeutic potential for relief of arthritis pain-related behaviours and inflammation without evident side-effects.

025.-brain-injury.pdf
030.-Treatment-of-spinal-cord-injury.pdf

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Connecticut has “damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity” as a qualifying condition in its medical marijuana program.

Illinois lists “Post-Concussion Syndrome”, “Spinal cord disease (including but not limited to arachnoiditis)”, “Spinal cord injury with damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity” and Traumatic Brain Injury as qualifying conditions in its medical marijuana program.

New Hampshire lists “spinal cord injury or disease” and traumatic brain injury as qualifying conditions in its medical marijuana program.

Ohio lists chronic traumatic encephalopathy, “spinal cord disease or injury” and traumatic brain injury as qualifying conditions in its medical marijuana program.

Pennsylvania lists “damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity” as a qualifying condition for its medical marijuana program.

Washington lists Traumatic brain injury as a qualifying condition for its medical marijuana program.

West Virginia lists “Damage to the nervous tissue of the spinal cord with objective neurological indication of intractable spasticity.” as a qualifying condition for its medical marijuana program.

Oregon has added “a degenerative or pervasive neurological condition” to its medical marijuana program qualifying conditions. 

031.-asthma.pdf
Effects of smoked marijuana in experimentally induced asthma.

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After experimental induction of acute bronchospasm in 8 subjects with clinically stable bronchial asthma, effects of 500 mg of smoked marijuana (2.0 per cent delta9-tetrahydrocannabinol) on specific airway conductance and thoracic gas volume were compared with those of 500 mg of smoked placebo marijuana (0.0 per cent delta9-tetrahydrocannabinol), 0.25 ml of aerosolized saline, and 0.25 ml of aerosolized isoproterenol (1,250 mug). After exercise-induced bronchospasm, placebo marijuana and saline were followed by gradual recovery during 30 to 60 min, whereas 2.0 per cent marijuana and isoproterenol caused an immediate reversal of exercise-induced asthma and hyperinflation.

Our present findings and those previously reported demonstrated acute airway dilatation after smoked marijuana.

Effects of cannabis on lung function: a population-based cohort study

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Cumulative cannabis use was associated with higher forced vital capacity, total lung capacity, functional residual capacity and residual volume. Cannabis was also associated with higher airway resistance but not with forced expiratory volume in 1 s, forced expiratory ratio or transfer factor. These findings were similar among those who did not smoke tobacco. 

Newspaper ad from 1876 selling marijuana cigarettes for treating asthma.

You may laugh at a marijuana cigarette as a real medical treatment, but marijuana is a verified bronchodilator similar in strength to albuterol, the standard asthma medication. The medical efficacy of this specific brand of Asthma cigarettes were specifically exempted within the Single Convention on Narcotic Drugs as created by the United Nations. This means these marijuana cigarettes were still able to be sold after each country banned marijuana.

https://www.unodc.org/unodc/en/data-and-analysis/bulletin/bulletin_1951-01-01_4_page002.html

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PREPARATIONS NOTIFIED AS EXEMPTED FROM NARCOTIC CONTROL

5. Indian Cigarettes of Grimault (Dr. Ph. Chapelle) C.L.302.1930.III. Annex I.
Government: Siam
Ingredients:
Belladonna leaves – 0.962 gm
Cannabis indica extract – 0.0005 gm.
Nitrate of potash – 0.033 gm.

https://www.unodc.org/unodc/en/data-and-analysis/bulletin/bulletin_1962-01-01_4_page005.html

Quote

Preparations made from the extract and tincture which are capable only of external use, and a medicinal cigarette called “Indian Cigarettes of Grimault” (Dr. P. H. Chapelle) are exempted from control.

036.-diabetes.pdf
The Health Effects of Cannabis and Cannabinoids The Current State of Evidence and Recommendations for Research (2017)

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Counterintuitively, the majority of the reviewed studies showed that cannabis was associated with a lower BMI or a lower prevalence of obesity, or both (Hayatbakhsh et al., 2010; Le Strat and Le Foll, 2011; Smit and Crespo, 2001; Warren et al., 2005), or to have no association with BMI or obesity (Rodondi et al., 2006).

The Impact of Marijuana Use on Glucose, Insulin, and Insulin Resistance among US Adults

Quote

In this large, cross-sectional study, we found that subjects who reported using marijuana in the past month had lower levels of fasting insulin and HOMA-IR, as well as smaller waist circumference and higher levels of HDL-C. These associations were attenuated among those who reported using marijuana at least once, but not in the past 30 days, suggesting that the impact of marijuana use on insulin and insulin resistance exists during periods of recent use.

In the present study, we demonstrate a significant association between current marijuana use and lower levels of fasting insulin and insulin resistance in multivariable adjusted analyses even after excluding participants with prevalent diabetes mellitus.

With the recent trends in legalization of marijuana in the United States, it is likely that physicians will increasingly encounter patients who use marijuana and should therefore be aware of the effects it can have on common disease processes, such as diabetes mellitus. We found that current marijuana use is associated with lower levels of fasting insulin, lower HOMA-IR, and smaller waist circumference.

044.-colitis.pdf
050.-gastric-ulcer.pdf
055.-Inflammatory-bowel-disease-IBD.pdf
064.-Ulcerative-colitis.pdf
Marijuana Use Patterns Among Patients with Inflammatory Bowel Disease

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Our findings suggest that patients with UC may also benefit from the use of medicinal marijuana although the 11 states that have legalized medical marijuana have only approved its use for only patients with CD. Lawmakers should consider adding this condition to the list of acceptable diseases that may be treated with medicinal marijuana.

Minnesota Medical Cannabis Program: Patient Experiences from the First Program Year by the MN Department of Health 2016.

Quote

Number of liquid/soft stools per day decreased by ≥30% for 51.2% of patients with at least five liquid/soft stools per day at baseline. Among patients who achieved ≥30% reduction, 57% (29.3% of patients included in analysis at baseline) retained that level of improvement over the next four months.

Severity of abdominal pain improved for 53.4% of patients with moderate or severe abdominal pain at baseline. Among patients who reported an improvement in abdominal pain, 36% (19.2% of patients included in analysis at baseline) retained that improvement over the next four months.

General well-being improved for 46.7% of patients who described their baseline well-being as “Very Poor” or “Terrible” at baseline. Among patients who reported an improvement in general well-being, 29% (13.3% of patients included in analysis at baseline) retained that improvement over the next four months.

On the combined Crohn’s activity measure (number of liquid/soft stools, abdominal pain, general well-being), 51.0% of Crohn’s Disease patients achieved ≥30% improvement. Among patients who achieved ≥30% reduction, 42% (21.6% of patients included in analysis at baseline) retained that level of improvement over the next four months. An increase of at least 3% in body weight was reported by 20.6% of patients. Among the patients who achieved ≥3% increase in body weight, 57% (11.8% of patients included in analysis at baseline) retained that increase over the next four months.

Cannabinoids and the Urinary Bladder

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To date, a small number of open-label and placebo-controlled studies have demonstrated that oral administration of cannabinoids may alleviate OAB/DO symptoms as first line. Most of these studies have been carried out on patients with advanced multiple sclerosis using preparations containing Δ9 -THC and/or CBD. One such study using Sativex, showed a reduction in urgency, number of incontinence episodes, frequency and nocturia in patients with multiple sclerosis.

Cannabinoids and gastrointestinal motility: Animal and human studies

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The plant Cannabis has been known for centuries to be beneficial in a variety of gastrointestinal diseases, including emesis, diarrhea, inflammatory bowel disease and intestinal pain.

Medical cannabis – the Canadian perspective

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Case Report

The patient was prescribed 1 g per day of a cannabis strain containing 9% THC and 13% CBD to be administered by a vaporizer. At 60 days of follow-up, the patient’s pain was lowered to a weekly average of 3/10 on a numerical rating scale. The patient also indicated he did not see a need for pregabalin, and had begun the process of lowering his daily dose. Surprisingly, the patient also reported far fewer symptoms of his irritable bowel syndrome, claiming near-remission.

Impact of cannabis treatment on the quality of life, weight and clinical disease activity in inflammatory bowel disease patients: a pilot prospective study.

Quote

Thirteen patients were included. After 3 months’ treatment, patients reported improvement in general health perception, social functioning, ability to work , physical pain  and depression. A schematic scale of health perception showed an improved score. Patients had a weight gain of 4.3 ± 2 kg during treatment and an average rise in BMI of 1.4 . The average Harvey-Bradshaw index was reduced.

CONCLUSIONS:

Three months’ treatment with inhaled cannabis improves quality of life measurements, disease activity index, and causes weight gain and rise in BMI in long-standing IBD patients.

106.-organ-transplant.pdf

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4541500/

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Together, the current study shows, for the first time to our knowledge, that the CB-ligand system may have a critical role in allograft rejection. THC treatment reduced the T cell response in the host by dampening the secretion of proinflammatory cytokines and expression of T cell activation markers. Additionally, THC treatment resulted in delayed graft destruction, even in a MHC disparity model of allogenic skin transplant. Induction of highly immunosuppressive MDSCs following THC treatment proved to be necessary, at least in part, for THC-mediated attenuation of allograft rejection. We also noted that this effect of THC was dependent on activation of CB1 rather than CB2. The current study sets the stage for additional studies on the cannabinoid system in regulating transplant rejection involving potential manipulation of endocannabinoids, receptors, and the use of CB-select agonists that are not psychoactive.

Medical Marijuana and Organ Transplantation: Drug of Abuse, or Medical Necessity?

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The case was in the evening news a few days later and generated much press coverage. Despite this, the transplant team held firm even when other physicians advocated for the patient and noted that there was no scientific literature showing any increased risk of organ damage or rejection from someone using marijuana. Tragically, the patient died of liver failure 3 weeks later, leaving behind his wife and 2 children, ages 8 and 12. In the actual case, the ethics team was never consulted or even formally made aware of this case. This patient was following the state law, allowing him to use marijuana to treat his pain, nausea, and vomiting, which turned out to be the only thing that worked. Despite following state laws, this state funded university hospital turned him down for a liver transplant.

107.-Non-severe-and-non-chronic-Pain.pdf

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3998228/

Quote

In order to discover the benefits and adverse effects perceived by medical cannabis patients, especially with regards to chronic pain, we hand-delivered surveys to one hundred consecutive patients who were returning for yearly re-certification for medical cannabis use in Hawai‘i.

The response rate was 94%. Mean and median ages were 49.3 and 51 years respectively. Ninety-seven per cent of respondents used cannabis primarily for chronic pain. Average pain improvement on a 0–10 pain scale was 5.0 (from 7.8 to 2.8), which translates to a 64% relative decrease in average pain. Half of all respondents also noted relief from stress/anxiety, and nearly half (45%) reported relief from insomnia. Most patients (71%) reported no adverse effects, while 6% reported a cough or throat irritation and 5% feared arrest even though medical cannabis is legal in Hawai‘i. No serious adverse effects were reported.

These results suggest that Cannabis is an extremely safe and effective medication for many chronic pain patients. Cannabis appears to alleviate pain, insomnia, and may be helpful in relieving anxiety. Cannabis has shown extreme promise in the treatment of numerous medical problems and deserves to be released from the current Schedule I federal prohibition against research and prescription.

LARA statistics show the majority of the 250,000+ patients in the MMMA are using cannabis to treat chronic pain. As we know that the medical use of marijuana can treat “severe and chronic pain” already, it can and should be used to treat regular generic pain that is not severe and chronic.

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Severe and Chronic pain 79.99%

Severe and Chronic pain 92.77%

The reports and information from the Minnesota Department of Health on its medical marijuana program are very detailed and informative about patients experiences with medical marijuana.

Minnesota Medical Cannabis Program: Patient Experiences from the First Program Year by the MN Department of Health 2016.

http://www.health.state.mn.us/topics/cannabis/about/appendixa.pdf

Quote

• it works quickly to relieve muscle spasms,,helps control pain during physical work, controls pain to a certain extent, helps give you opportunity to quality of life.
•  [PATIENT]’s mobility has increased.
•  some pain relief
•  Less lower back pain, increased apatite.
•  Less muscle aches and better sleep.
•  Less muscle spasm’s = body not being as fatigued allowing me to perform my physical therapy better.
•  Less muscle spasms!!
•  less mussel spasms and pain
•  less nerve pain
•  Less pain and inflammation in legs and ankles. Didn’t feel so wore out at the end of the day. Was able to relax and sit for long periods with less stiffness and joint pain. Overall I had less pain
•  Less Pain
• Less sleep issues
• More hunger’
• Less mood swings
• All around better feeling of life
•  less petit mal seizures , better sleep at night and , reduced muscles pasms
•  less seizures
•  Less spasms helps me relax.
•  Many fewer spasms. I went from several per hour every day to several per day. Much improvement! I also have less anxiety. My confidence has increased from feeling more relaxed.
•  Much less pain, in my bowel and neurapathy pain. I can tell almost immediately if I forget to take the medication. Within one or two hours, the pain in the gut/bowel area is back. I never realized how terrible I have felt until after I started to feel better. I have had bowel pain as long as I can remember (pre-school) and I thought everyone felt like that. It is all I ever knew and it was getting worse eachyear.
•  much less weakness/pain
• easier sleeping
• not as many spasms in the morning

108.-Parkinsons.pdf

Other states already approve of medical marijuana for Parkinson’s Disease.

Including: Georgia, Vermont, Connecticut, Florida, Illinois, Massachusetts, New Hampshire, Ohio, New Mexico, New York, Pennsylvania, West Virginia and California

http://www.google.com/patents/US6630507

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Original Assignee

The United States Of America As Represented By The Department Of Health And Human Services

The cannabinoids are found to have particular application as neuroprotectants, for example in limiting neurological damage following ischemic insults, such as stroke and trauma, or in the treatment of neurodegenerative diseases, such as Alzheimer’s disease, Parkinson’s disease and HIV dementia.

As used herein, a “cannabinoid” is a chemical compound (such as cannabinol, THC or cannabidiol) that is found in the plant species Cannabis sativa (marijuana)

111.-Tourette’s-Syndromequalifying.pdf

Tourette’s Syndrome is an approved medical marijuana qualifying condition in Arkansas, Illinois, Minnesota and Ohio. While the MMMA covers persistant and severe Muscle Spasms, Tourette’s Syndrome sufferers may not have the severe symptoms that qualify.

The 1999 Institute of Medicine report states that marijuana can be used to treat Tourettes
Syndrome.

Quote

Neurological disorders affect the brain, spinal cord, or peripheral nerves and muscles in
the body. Marijuana has been proposed most often as a source of relief for three general
types of neurological disorders: muscle spasticity, particularly in multiple sclerosis
patients and spinal cord injury victims; movement disorders, such as Parkinson’s
disease, Huntington’s disease, and Tourette’s syndrome; and epilepsy. Marijuana is not
proposed as a cure for such disorders, but it might relieve some associated symptoms.

Clinical reports consist of four case histories indicating that marijuana use can reduce
tics in Tourette’s patients. In three of the four cases the investigators suggest that
beneficial effects of marijuana might have been due to anxiety-reducing properties of
marijuana rather than to a specific anti tic effect.

112.-MMRP-Autism-Petition-2qualifying.pdf

Pennsylvania Medical Marijuana Program lists Autism as a qualifying condition.

There are two clinical trials for Autism and cannabis in 2017:

Cannabinoids for Behavioral Problems in Autism Spectrum Disorder: A Double Blind, Randomized, Placebo-controlled Trial With Crossover.

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Detailed Description:

Disruptive behaviors are very common in children and youth with autism spectrum disorder (ASD). Behavioral problems increase social impairment in children with ASD, make interventions more difficult and place considerable strain on families and caregivers. Current treatment is based on behavioral interventions combined with atypical antipsychotics which often have low tolerability and questionable efficacy.

Cannabis exerts profound effects on human social behavior. Research using animal models of ASD indicate a possible dysregulation of the endocannabinoid system, and stress that it may be a novel target for pharmacological interventions. Anecdotal evidence suggest efficacy of various phytocannabinoids in resistant behavioral problems. However controlled human studies are lacking.

Objective: To assess the safety, tolerability and efficacy of cannabinoids mix [cannabidiol (CBD), Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio] for behavioral problems in children and youth with ASD.

Setting: A double blind randomized placebo-controlled trial with crossover. Methods: One hundred and twenty participants ages 6-30 years, with established ASD diagnosis and moderate to severe refractory behavioral problems will be treated with placebo and cannabinoids mix in a randomized cross-over trial. Each intervention period will be 12 weeks with additional 4 weeks for gradual dose decrease and wash-out. Baseline evaluations will include: Autism diagnostic observation schedule (ADOS-2), Social Communication Questionnaire (SCQ), Vineland II (interview based), Childhood Autism Rating Scale (CARS-2, observation based). Primary outcome measures: Home Situations Questionnaire-Autism Spectrum Disorder (HSQ-ASD), Child Behavior Checklist (CBCL, parent-rated), and Autism Parenting Stress Index (APSI) will be assessed every 4 weeks. Secondary outcome measures: Clinical Global Impression (CGI, improvement and efficacy index items, clinician-rated) and Social Responsiveness Scale (SRS, parent and teacher rated) will be assessed at baseline and termination of each treatment period. Adverse events will be taped every 4 weeks.

Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)

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Sponsor:

Montefiore Medical Center

Collaborator:

United States Department of Defense

Study Description

This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD.

Study Type  :    Interventional  (Clinical Trial)
Estimated Enrollment  :    100 participants
Allocation:    Randomized
Intervention Model:    Parallel Assignment
Intervention Model Description:    Phase 2, 12-week double-blind, randomized, placebo-controlled trial
Masking:    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:    Double-Blind
Primary Purpose:    Treatment

https://nccih.nih.gov/health/autism

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Marijuana hasn’t been studied for ASD, though there’s interest in its use by some patient groups to help with behavioral symptoms associated with ASD.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5473390/

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Behavioral Conditions. Cannabinoids and CBD use in this patient population is a growing interest on social media sites. While the data for these indications are limited to case reports using dronabinol, some of the benefits of CBD on behavior and motor skills reported in the aforementioned retrospective studies in epilepsy may be transferable to this population as well. A 6-year-old patient with early infant autism received enteral dronabinol drops titrated up to 3.62 mg/day. He had improvements in hyperactivity, irritability, lethargy, stereotype, and speech.41 In a published abstract, Kruger et al42 report on the effect of dronabinol use in treating self-injurious behavior in 10 mentally retarded adolescents. The dronabinol dose ranged from 2.5 mg twice daily to 5 mg 4 times a day. Seven of the 10 patients had significant improvement in their self-injurious behavior that lasted through the follow-up at 6 months. Two of the 10 patients experienced agitation and the drug was discontinued. An Israeli single-center, double-blind, placebo-controlled cross-over trial of CBD and THC in a 20:1 mixture for behavioral problems in children with autistic spectrum disorder is scheduled to start in January 2017.43

Safety and Efficacy of Medical Cannabis Oil for Behavioral and Psychological Symptoms of Dementia: An-Open Label, Add-On, Pilot Study.

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RESULTS:

Ten patients completed the trial. Significant reduction in CGI severity score (6.5 to 5.7; p <  0.01) and NPI score were recorded (44.4 to 12.8; p <  0.01). NPI domains of significant decrease were: Delusions, agitation/aggression, irritability, apathy, sleep and caregiver distress.

CONCLUSION:

Adding Medical Cannabis Oil to Alzheimer’s disease patients’ pharmacotherapy is safe and a promising treatment option.

An Open Label Study of the Use of Dronabinol (Marinol) in the Management of Treatment-Resistant Self-Injurious Behavior in 10 Retarded Adolescent Patients

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Conclusions: In a series of patients who presented with treatment-
resistant self-injurious behavior, eight of the 10 showed an improvement
in their behavior when treated with Marinol without serious enough side
effects to merit discontinuing the medication. At 6 month follow-up,
seven of the 10 continued to benefit from the Marinol, and the eighth
patient had discontinued the medicine due to a change in her living
situation. The tolerability of Marinol in this study is consistent with the
experience of Lorenz (2004) whose patients presented with a variety of neurological disorders but not specifically SIB.

 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4648553/

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Anecdotal reports continue to emerge of children with intractable epilepsy and severe autism who show symptomatic improvement after being administered cannabinoids. The call from the public for research on cannabinoids is growing louder and many families are already using marijuana for childhood conditions – this despite very little evidence on efficacy and in the face of known long-term harms. The medical community has an urgent duty to respond. As we face a tide of rapidly changing attitudes and policies on marijuana in the US and elsewhere, it is urgent that we prioritize carefully conducted RCTs to close the current knowledge gap.

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