Roundup of clinical trials of cannabis and cannabinoids. In this update: autism, PTSD, epilepsy, COPD, postoperative pain, and spasticity.
New Study Starts:
1. Cannabinoids for Behavioral Problems in Children with ASD
This study will assess the use of a cannabinoids in 120 children and youth with autism spectrum disorder (ASD). Using a randomized crossover design, participants will be treated with either placebo or a cannabinoid mix (20:1 ratio of CBD to THC) for 3 months each. The primary outcome is a parent-rated scale of the severity of ASD symptoms.
The study is run by Shaare Zedek Medical Center in Israel and is expected to be complete by July 2019.
2. Study of Four Different Potencies of Smoked Marijuana in 76 Veterans with Chronic, Treatment-Resistant PTSD
This study of military veterans with chronic post-traumatic stress disorder (PTSD) will examine how different types of cannabis affect the severity of their PTSD symptoms. Using a blinded, placebo-controlled, crossover design, each subject will use two of four different types of cannabis for a 3 week period. The four types of cannabis are the following:
- High THC – low CBD
- Low THC – high CBD,
- High THC – high CBD (equal ratio)
- Very low THC – very low CBD (placebo)
The study is sponsored by the Multidisciplinary Association for Psychedelic Studies (of which I’m a long-time fan) and is expected to be complete by January 2019.
3. Cannabinoid Therapy for Pediatric Epilepsy
This open-label Phase 1 study is examining a cannabis extract as adjunct therapy in 20 children with drug-resistant epilepsy due to Dravet Syndrome.
Patients will receive the CBD-rich whole plant extract (TIL-TC150) produced by a Canadian company called Tilray. Although the primary purpose is to establish tolerability of this extract, change in seizure frequency and quality of life will also be measured.
The study is being carried out by The Hospital for Sick Children in Toronto and is expected to be complete by August, 2018.
4. CAN BREATHE in COPD Trial
This Phase 2 study will examine the effects of vaporized cannabis in adults with chronic obstructive pulmonary disease (COPD).
Using a double-blind crossover design, 16 patients will receive 35 mg of of 1% THC/ 1% CBD (placebo) or 18% THC/ 1% CBD cannabis. Perceived breathlessness and endurance time will be measured during an exercise challenge.
This study is being conducted by McGill University in Montreal. It is expected to be completed by April, 2018.
1. Anesthetic Premedication With a Cannabis Extract
This Phase 2/3 trial examined whether a cannabis extract administered prior to surgery can reduce postoperative pain, nausea and vomiting, and pre- and postoperative anxiety.
This was a randomized, parallel-arm trial of 200 participants who received one of 4 different treatments prior to surgical anaesthesia:
- Nabiximols high dose (21.6 mg THC + 20 mg CBD)
- Nabiximols low dose (10.8 mg THC + 10 mg CBD)
- Active placebo (1 mg midazolam + 1 g acetaminophen IV)
- Placebo (no premedication)
This study was conducted by Hadassah Medical Organization in Israel in conjunction with GW Pharmaceuticals. It’s estimated completion date was February 2017, although study details have not been updated since March, 2016.
2. A Safety, Efficacy and Tolerability Study of Sativex for the Treatment of Spasticity in Children Aged 8 to 18 Years
This Phase 3 study examined the effects of Sativex spray on spasticity in 72 children with cerebral palsy or traumatic CNS injury.
This investigation was a double-blind, randomized, parallel group study of placebo versus Sativex spray (variable dose up to 32.4 mg THC + 30 mg CBD). Muscle spasticity was measured over a treatment period of 3 months.
This study was sponsored by GW Research and conducted by Evelina Children’s Hospital in London. It started in December 2013 and it’s anticipated completion date was March, 2017.
All information is from ClinicalTrials.gov
[Featured image: Pixabay]
Last modified: August 7, 2017