Obesity is a serious health problem which increases the likelihood of developing other life-changing medical conditions. Despite increasing knowledge about the neural and metabolic basis of obesity, the development of effective anti-obesity treatment strategies has been a challenge. Evidence shows an association between cannabis consumption and body weight. However, to date, no human trials have assessed the potential of cannabis-like compounds to reduce body weight in individuals who are obese. This pilot trial aims to determine the safety and feasibility of administering nabilone (a cannabinoid drug similar to the active component of cannabis) to patients who are obese. Our secondary aims are to determine if nabilone is effective in reducing weight in this population, and to probe potential mechanisms of the weight-loss-promoting effects of nabilone, such as neural reactivity to food stimuli, changes in gut bacteria, and changes in metabolic biomarkers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
18
Six placebo capsules taken orally twice daily
Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
Center for Addiction and Mental Health
Toronto, Ontario, Canada
Number of SAEs Per Treatment Arm
Number of SAEs collected to assess nabilone safety
Time frame: 12 weeks of treatment
Number of Dropouts Per Treatment Arm
Number of dropouts collected to assess feasibility of study design and intervention
Time frame: 12 weeks of treatment
Body Weight
Change in body weight
Time frame: Baseline, one weekly visit for Weeks 1-12, then one discharge visit (Week 13)
Abdominal Fat
Change in abdominal fat, as measured by abdominal MRI
Time frame: One scan at baseline and one scan at Week 12
Blood Glucose Levels
Change in metabolic biomarker (blood levels of glucose)
Time frame: Blood drawn at baseline, Week 5, Week 9, and Week 12
Blood Insulin Levels
Change in metabolic biomarker (blood levels of insulin)
Time frame: Blood drawn at baseline, Week 5, Week 9, and Week 12
Blood Triglyceride Levels
Change in metabolic biomarker (blood triglyceride levels)
Time frame: Blood drawn at baseline, Week 5, Week 9, and Week 12
Blood Cholesterol Levels
Change in metabolic biomarker (blood levels of HDL and LDL \[total cholesterol\])
Time frame: Blood drawn at baseline, Week 5, Week 9, and Week 12
Blood Leptin Levels
Change in hunger-related hormones (blood levels of leptin)
Time frame: Blood drawn at baseline, Week 5, Week 9, and Week 12
Blood Ghrelin Levels
Change in hunger-related hormones (blood levels of ghrelin)
Time frame: Blood drawn at baseline, Week 5, Week 9, and Week 12
Blood PYY Levels
Change in hunger-related hormones (blood levels of PYY)
Time frame: Blood drawn at baseline, Week 5, Week 9, and Week 12
Gut Microbiota
Stool samples collected for quantification of gut microbiome composition; outcome measure is change in beta diversity (Bray-Curtis dissimilarity metric) from baseline to Week 12. The Bray-Curtis dissimilarity is bounded between 0 and 1, where 0 means the two sites have the same composition (i.e., pre and post samples share all the species), and 1 means the two sites do not share any species.
Time frame: Baseline, Week 12
Neural Reactivity to Food vs. Control Stimuli
Task-based fMRI to determine differences in neural reactivity to food vs. control pictures
Time frame: Baseline, Week 12
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