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Trial Will Test Synthetic Cannabinoid for Weight Loss in ObesityJanuary 20, 2022 by Editorial staff
Researchers are about to enroll the first patient in a pilot study for potential weight loss with nabilone – a synthetic drug similar to the active ingredient in the marijuana plant (hemp).
Although cannabis has been linked to “beverages,” paradoxically, people who use cannabis regularly have a lower body mass index (BMI), lower risk of obesity, and a lower risk of developing diabetes than people who don’t use cannabis,” Justin Matheson, Ph.D., University of Toronto, Ontario, Canada, in an article in UT News.
Matheson, a postdoctoral research fellow at the Center for Addiction and Mental Health, said in an interview with Medscape Medical News.
“Unfortunately, the drugs that have been tried before, cannabinoid receptor antagonists,” such as rimonabant, “already have serious psychological adverse effects,” he noted.
However, nabilone, which is approved to treat nausea, has an acceptable safety profile, and animal studies suggest that it may be effective for weight loss in obese patients.
Therefore, the researchers, led by Bernard Le Foll, PhD, and chair of addiction psychiatry at Timerte School of Medicine, University of Toronto, designed a preliminary feasibility and safety study to test this hypothesis.
“Hope to see [weight-loss] “Effects without those serious psychological adverse effects,” Matheson said.
First human study of Nabilone for weight loss in obesityDelta-9-tetrahydrocannabinol (Δ9-THC), commonly known as THC, is the primary psychoactive compound found in the marijuana plant and is one of several cannabinoids.
Le Foll was part of a research group that published a study that showed that Δ9-THC reduced weight gain in mice with diet-induced obesity but not in lean mice.
The current feasibility study will investigate the potential weight loss effect of nabilone, a synthetic cannabinoid similar to naturally occurring Δ9-THC, in obese people.
Sold under the brand name Cesamet in the United States, nabilone is approved by the U.S. Food and Drug Administration to treat nausea and vomiting caused by cancer chemotherapy. Nabilone has various brand names in Canada, where it is also available as the generic drug.
In clinical trials, the most common side effects of nabilone were drowsiness, dizziness, dry mouth, and euphoria.
The researchers plan to enroll 60 men and women aged 25-45 with a BMI >30 kg/m2 who have not used cannabis in the past
Patients will be randomized to receive a placebo, low-dose nabilone (titrated to 2 mg daily), or high-dose nabilone (titrated to 6 mg daily) for 12 weeks.
Generic Nabilone capsules are at a dose of 0.5 mg twice daily.
Primary outcomes are safety (serious and adverse events) and feasibility (study dropouts).
Secondary outcomes include effective weight loss (changes in body weight and abdominal fat).
Other secondary outcomes include:
- Changes in the gut microbiome (based on analysis of stool samples at baseline and week 12).
- Blood levels of metabolic markers such as glucose, insulin, cholesterol, leptin and ghrelin (at baseline and weeks 5, 9 and 12).
- Neural activity of the brain in response to images of food versus images of control (seen by functional magnetic resonance imaging).