A Pilot Trial of Nabilone for the Treatment of Obesity

Obesity Clinical Trial

Official title:

Impact of Chronic Nabilone Self-administration on Body Weight, Metabolic Markers, Gut Microbiota, and Neural Circuitry in Human Obesity

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04801641
• Other study ID #: 084/2018
• Status: Terminated
• Phase: Phase 2
• Start date: September 17, 2021
• Est. completion date: August 14, 2023

Study information

• Verified date: January 2024
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: August 14, 2023
• Est. primary completion date: August 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• Obese adults (BMI > 30.0 kg/m2).
• For the optional imaging component of the study, a maximum weight (315 lbs) and a maximum girth in line with capacity of the machine (60 cm horizontal and 45 cm vertical; therefore, circumference of scanner is 166.6 cm)
• For women of reproductive potential (WORP) and men whose sexual partners are WORP: use of adequate methods of contraception (effective barrier methods such as male condoms, female condoms, cervical caps, diaphragms, or contraceptive sponges; and highly effective methods of contraception such as oral hormonal contraceptives, intrauterine devices (IUDs), vasectomy, or tubal ligation)
• AST/ALT, bilirubin, and kidney function tests within normal limits at screening.

Exclusion Criteria:

• Unstable gastrointestinal, respiratory, endocrinological, cardiovascular or cerebrovascular diseases that would prevent participation in the trial at QI (or its delegate) discretion,
• Unstable major psychiatric disorder(s) (i.e. Axis I Disorders) that would prevent participation in the trial at QI (or its delegate) discretion,
• Current substance use disorders (DSM-V) (excluding tobacco and caffeine),
• History of, or current neurological illnesses, that would prevent participation in the trial,
• Current use or use during the previous month of antipsychotic medications,
• Learning disability, amnesia or other conditions that impede memory and attention,
• Visual impairments that prevent participation in the study,
• Personal or family history of schizophrenia, or psychosis (or psychosis-related) disorders,
• Antibiotic use in the last 4 weeks,
• Previous bariatric surgery,
• Current use or use in the past month of other weight-loss pharmaceuticals,
• Cannabis use in last 6 months,
• Known sensitivity to cannabis or other cannabinoid agents,
• Pregnancy or lactation (females), and
• For the optional imaging component of the study:
• Presence of metal implants or objects unsafe for MRI such as cardiac pacemakers, metal fragments in the eye, and aneurysm clips in your brain
• Piercings or jewelry that are unable to be removed
• Tattoos inked with metal dyes

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Placebo
Six placebo capsules taken orally twice daily
• Nabilone
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)

Locations

Country	Name	City	State
Canada	Center for Addiction and Mental Health	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of SAEs per treatment arm	Number of SAEs collected to assess nabilone safety	12 weeks of treatment
Primary	Number of dropouts per treatment arm	Number of dropouts collected to assess feasibility of study design and intervention	12 weeks of treatment
Secondary	Body weight	Change in body weight	Baseline, then weekly for 12 weeks of treatment
Secondary	Abdominal fat	Change in abdominal fat, as measured by abdominal MRI	One scan at baseline and one scan at Week 12
Secondary	Blood glucose levels	Change in metabolic biomarker (blood levels of glucose)	Blood drawn at baseline, Week 5, Week 9, and Week 12
Secondary	Blood insulin levels	Change in metabolic biomarker (blood levels of insulin)	Blood drawn at baseline, Week 5, Week 9, and Week 12
Secondary	Blood triglyceride levels	Change in metabolic biomarker (blood triglyceride levels)	Blood drawn at baseline, Week 5, Week 9, and Week 12
Secondary	Blood cholesterol levels	Change in metabolic biomarker (blood levels of HDL and LDL)	Blood drawn at baseline, Week 5, Week 9, and Week 12
Secondary	Blood leptin levels	Change in hunger-related hormones (blood levels of leptin)	Blood drawn at baseline, Week 5, Week 9, and Week 12
Secondary	Blood ghrelin levels	Change in hunger-related hormones (blood levels of ghrelin)	Blood drawn at baseline, Week 5, Week 9, and Week 12
Secondary	Blood PYY levels	Change in hunger-related hormones (blood levels of PYY)	Blood drawn at baseline, Week 5, Week 9, and Week 12
Secondary	Gut microbiota	Stool samples collected for quantification of gut microbiome composition	Baseline, Week 12
Secondary	Neural reactivity to food vs. control stimuli	Task-based fMRI to determine differences in neural reactivity to food vs. control pictures	Baseline, Week 12