Roundup of clinical trials of cannabis and cannabinoids. In this update: retinitis pigmentosa, Dravet syndrome, cancer anorexia, obesity, and psoriasis.
New Study Starts (3Q 2017):
1. The Effects of Cannabis on Visual Functions in Healthy and Retinitis Pigmentosa Patients
Some evidence suggests that cannabinoids may be beneficial in certain degenerative diseases of the retina. This study of 40 patients will examine how different cannabis formulations affect visual functions in healthy adults and patients with retinitis pigmentosa
All subjects will undergo an ocular examine and visual functions will be assessed before and after a single sublingual dose of cannabis (THC:CBD 1:40). This will be repeated the following day with a higher THC formulation (THC:CBD 1:1).
Study completion is expected in 2020.
2. Effect of Medical Marijuana on Neurocognition and Escalation of Use
There are some concerns that patients who start using medical cannabis will suffer adverse consequences, such as dependence or cognitive impairment. This longitudinal study will compare patients who use medical cannabis with a control group. The study will assess:
- Impact on addiction indices (escalation of use, tolerance, withdrawal)
- Effect on use of other medications and disease symptoms
- Impact of cannabis on neurocognitive performance
- Examine evidence for impact of cannabis on brain structure and function
Study completion is expected in 2022.
Study Completions (3Q 2017):
1. Genetic Analysis Between Charlotte’s Web Responders Versus Non-Responders in a Dravet Population
Dravet Syndrome is a form of epilepsy caused by mutations in the SCN1A gene. Although a high-CBD strain of cannabis known as Charlotte’s Web helped some Dravet patients, not every patient responded.
This study will examine genetic differences between Dravet patient responders and non-responders. This will help identify patients who are likely to respond as well as identify possible mechanisms of how cannabis may exert an antiepileptic effect.
This study started in 2014 and completed in July, 2017.
2. Nabilone Effect on the Attenuation of Anorexia, Nutritional Status and Quality of Life in Lung Cancer Patients
Anorexia is a common symptom in cancer patients. Nabilone (synthetic oral THC) is approved for nausea and vomiting induced by chemotherapy. It is also used to increase appetite in palliative care units, although there were previously no studies in this setting.
This study randomized 78 lung cancer patients to nabilone at 0.5-1 mg/day or placebo for a treatment period of 8 weeks. Anorexia and weight loss were assessed.
This study started in 2014 and its expected completion was July, 2017.
3. CB1 Receptors in Human Brown Adipose Tissue
Endocannabinoids regulate energy balance and metabolism. Cannabinoid CB1 receptors are found in brown adipose tissue, which become metabolically activated when you are cold.
This study will enroll obese subjects and assess CB1 receptor density in brown adipose tissue, white adipose tissue, muscle, and brain under warm conditions and after controlled cold exposure.
This study will help understand endocannabinoid mechanisms of brown adipose tissue activation.
This study started in 2015 and was expected to be complete in July, 2017.
4. Study to Determine the Safety, Tolerability of Topical Cream Containing Medical Grade Cannabis in Healthy Volunteers
This study was meant to assess the safety of a topical cream (3% CBD and 3% THC) applied twice daily for up to 6 weeks. Although the cream is eventually intended for psoriasis patients, the study was to be carried out in healthy subjects.
The study was scheduled to start Feb, 2017 and complete July, 2017. However, no update has been provided to the database since 2016, so it is not confirmed whether the study occurred.
See prior report: Clinical Trials of Cannabinois – 2Q 2017
All information is from ClinicalTrials.gov. Not every trial related to cannabinoids is featured, just selected ones that highlight the therapeutic potential of cannabinoids.
[Featured image: Pixabay]
Last modified: January 4, 2018