A Pilot Trial of Nabilone for the Treatment of Obesity

Phase 2

Terminated

• Conditions: Obesity
• Interventions: Drug: Placebo; Drug: Nabilone

• Registration Number: NCT04801641
• Lead Sponsor: Centre for Addiction and Mental Health

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-04
• Study First Submitted QC: 2021-03-12
• Study First Posted: 2021-03-17
• Study Start: 2021-09-17
• Primary Completion: 2023-08-14
• Study Completion: 2023-08-14
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
High-Dose Nabilone	Nabilone	pms-nabilone titrated to 6 mg daily
Low-Dose Nabilone	Nabilone	pms-nabilone titrated to 2 mg daily

Primary Outcome Measures

Name	Time	Method
Number of SAEs per treatment arm	12 weeks of treatment	Number of SAEs collected to assess nabilone safety
Number of dropouts per treatment arm	12 weeks of treatment	Number of dropouts collected to assess feasibility of study design and intervention

Secondary Outcome Measures

Name	Time	Method
Blood glucose levels	Blood drawn at baseline, Week 5, Week 9, and Week 12	Change in metabolic biomarker (blood levels of glucose)
Blood leptin levels	Blood drawn at baseline, Week 5, Week 9, and Week 12	Change in hunger-related hormones (blood levels of leptin)
Neural reactivity to food vs. control stimuli	Baseline, Week 12	Task-based fMRI to determine differences in neural reactivity to food vs. control pictures
Abdominal fat	One scan at baseline and one scan at Week 12	Change in abdominal fat, as measured by abdominal MRI
Blood ghrelin levels	Blood drawn at baseline, Week 5, Week 9, and Week 12	Change in hunger-related hormones (blood levels of ghrelin)
Body weight	Baseline, then weekly for 12 weeks of treatment	Change in body weight
Blood insulin levels	Blood drawn at baseline, Week 5, Week 9, and Week 12	Change in metabolic biomarker (blood levels of insulin)
Blood triglyceride levels	Blood drawn at baseline, Week 5, Week 9, and Week 12	Change in metabolic biomarker (blood triglyceride levels)
Blood cholesterol levels	Blood drawn at baseline, Week 5, Week 9, and Week 12	Change in metabolic biomarker (blood levels of HDL and LDL)
Gut microbiota	Baseline, Week 12	Stool samples collected for quantification of gut microbiome composition
Blood PYY levels	Blood drawn at baseline, Week 5, Week 9, and Week 12	Change in hunger-related hormones (blood levels of PYY)

Trial Locations

Locations (1)

Center for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada