Israeli investigators intend to evaluate the potential anti-tumoral effects of the canabinoid cannabidiol (CBD) in select cancer patients.
Researchers at the Hassadah Medical Center in Jerusalem will conduct a Phase II clinical trial to assess the impact of CBD as single treatment in cancer patients who have failed to respond to conventional therapies. Participants in the trial will receive CBD therapy for a period of eight weeks.
Data documenting the potent anti-cancer activity of various cannabinoids – including THC, CBD, and CBG – both in culture and in animals dates back to the mid-1970s. To date, however, virtually no clinical trials exist reproducing these results in human subjects.
In August, pharmaceutical provider Insys Therapeutics announced that it had received orphan drug status for its proprietary formulation of CBD for the treatment of glioblastoma, a hard-to-treat, aggressive form of brain cancer.
Organic CBD remains classified under federal law as a schedule I controlled substance.
Further details of the forthcoming Israeli trial are available online from the clinicaltrials.gov website here. Patient recruitment has yet to begin for this study.
The administration of a single dose of whole-plant cannabis via a thermal-metered inhaler is effective and well tolerated among patients suffering from neuropathy (nerve pain), according to clinical trial data published online ahead of print in the Journal of Pain and Palliative Care Pharmacotherapy.
Israeli investigators assessed the efficacy of a novel, portable metered-dose cannabis inhaler in eight subjects diagnosed with chronic neuropathic pain. Researchers reported that the device administered an efficient, consistent, and therapeutically effective dosage of cannabinoids to all participants.
They concluded, “This trial suggests the potential use of the Syqe Inhaler device as a smokeless delivery system of medicinal cannabis, producing a delta-9-THC pharmacokinetic profile with low inter-individual variation of (maximum drug/plasma concentrations), achieving pharmaceutical standards for inhaled drugs.”
A series of clinical trials conducted by investigators affiliated with the Center for Medicinal Cannabis Research at the University of California, San Diego previously determined that the inhalation of whole-plant cannabis is efficacious in the treatment of neuropathic pain.
Full text of the study, “The pharmacokinetics, efficacy, safety, and ease of use of a novel portable metered-dose cannabis inhaler in patients with chronic neuropathic pain: A phase 1a study,” will appear in the Journal of Pain and Palliative Care Pharmacotherapy.
The administration of oral THC mitigates symptoms of post-traumatic stress syndrome (PTSD), according to clinical trial data published online ahead of print in the journal Clinical Drug Investigation.
Investigators at the Hebrew University Medical Center in Jerusalem assessed the safety and efficacy of oral THC as an adjunct treatment in ten subjects with chronic PTSD.
Researchers reported, “The intervention caused a statistically significant improvement in global symptom severity, sleep quality, frequency of nightmares, and PTSD hyperarousal symptoms.”
They concluded, “Orally absorbable delta-9-THC was safe and well tolerated by patients with chronic PTSD.”
Separate clinical trial data has previously reported that the administration of nabilone, a synthetic endocannabinoid agonist, can reduce the severity and frequency of nightmares in patients with PTSD.
In 2013, researchers at the New York University School of Medicine published findings indicating that PTSD subjects experience a decrease in their natural production of anandamide, an endogenous cannabinoid neurotransmitter. They hypothesized that an increase in the body’s production of cannabinoids would likely restore subjects’ natural brain chemistry and psychological balance. “[Our] findings substantiate, at least in part, emerging evidence that … plant-derived cannabinoids such as marijuana may possess some benefits in individuals with PTSD by helping relieve haunting nightmares and other symptoms of PTSD,” they concluded.
Full text of the study, “Preliminary, open-label, pilot study of add-on oral delta-9-tetrahydrocannabinol in chronic post-traumatic stress disorder,” will appear in Clinical Drug Investigation.
Inhaling whole-plant cannabis provides symptomatic relief in patients with Parkinson’s disease (PD), according to observational trial data published in the March/April edition of the journal Clinical Neuropharmacology. Parkinson’s is a progressive disorder of the central nervous system that results in tremor, slowed movement, and muscle rigidity.
Investigators at Tel Aviv University, Department of Neurology evaluated Parkinson’s disease symptoms in 22 patients at baseline and 30-minutes after inhaling cannabis.
Researchers reported that inhaled cannabis was associated with “significant improvement after treatment in tremor, rigidity, and bradykinsea (slowness of movement). There was also significant improvement of sleep and pain scores. No significant adverse effects of the drug were observed.”
They concluded: “[T]his observational study is the first to report an amelioration of both motor and non–motor symptoms in patients with PD treated with cannabis. The study opens new venues for treatment strategies in PD especially in patients refractory to current medications.”
Israel has formally allowed for the licensed production and distribution of the substance for therapeutic purposes since 2011.
An abstract of the study, “Cannabis (Medical Marijuana) Treatment for Motor and Non–Motor Symptoms of Parkinson Disease: An Open-Label Observational Study,” is online here.
Inhaling cannabis reduces symptoms of Crohn’s disease compared to placebo in patients non-responsive to traditional therapies, according to clinical trial data published online ahead of print in the journal Clinical Gastroenterology and Hepatology.
Researchers at the Meir Medical Center, Department of Gastroenterology and Hepatology in Israel assessed the safety and efficacy of inhaled cannabis versus placebo in 21 subjects with Crohn’s disease who were nonresponsive to conventional treatments.
Eleven participants smoked standardized cannabis cigarettes containing 23 percent THC and 0.5 percent CBD (cannabidiol) twice daily over a period of eight weeks. The other ten subjects smoked placebo cigarettes containing no active cannabinoids.
Investigators reported, “Our data show that 8-weeks treatment with THC-rich cannabis, but not placebo, was associated with a significant decrease of 100 points in CDAI (Crohn’s Disease and activity index) scores.” (The CDIA is a research tool used to quantify the symptoms of Crohn’s disease patients.) Five of the eleven patients in the study group also reported achieving disease remission (defined as a reduction in patient CDAI score by more than 150 points).
Researchers also reported that “no significant side effects” were associated with cannabis inhalation. Subjects in the study group reported improvements in appetite and sleep compared to those in the placebo group. Cannabis inhalation was also associated with “significantly less pain” among the participants.
The study is the first placebo-controlled clinical trial to assess the consumption of cannabis for the treatment of Crohn’s.
Israeli researchers had previously published observational trial data reporting that Crohn’s patients require fewer disease-related surgeries following their use of cannabis.
According to survey data published in 2011 in the European Journal of Gastroenterology and Hepatology, some one-half of Crohn’s disease patients acknowledge having used cannabis to mitigate their disease symptoms.