A Pilot Trial of Nabilone for the Treatment of Obesity

Sponsor
Centre for Addiction and Mental Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT04801641
Collaborator
(none)
60
1
3
19.4
3.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
Impact of Chronic Nabilone Self-administration on Body Weight, Metabolic Markers, Gut Microbiota, and Neural Circuitry in Human Obesity
Actual Study Start Date :
Sep 17, 2021
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: Placebo

Placebo

Drug: Placebo
Six placebo capsules taken orally twice daily

Experimental: Low-Dose Nabilone

pms-nabilone titrated to 2 mg daily

Drug: 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)

Experimental: High-Dose Nabilone

pms-nabilone titrated to 6 mg daily

Drug: 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)

Outcome Measures

Primary Outcome Measures

  1. Number of SAEs per treatment arm [12 weeks of treatment]

    Number of SAEs collected to assess nabilone safety

  2. 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

  1. Body weight [Baseline, then weekly for 12 weeks of treatment]

    Change in body weight

  2. Abdominal fat [One scan at baseline and one scan at Week 12]

    Change in abdominal fat, as measured by abdominal MRI

  3. Blood glucose levels [Blood drawn at baseline, Week 5, Week 9, and Week 12]

    Change in metabolic biomarker (blood levels of glucose)

  4. Blood insulin levels [Blood drawn at baseline, Week 5, Week 9, and Week 12]

    Change in metabolic biomarker (blood levels of insulin)

  5. Blood triglyceride levels [Blood drawn at baseline, Week 5, Week 9, and Week 12]

    Change in metabolic biomarker (blood triglyceride levels)

  6. Blood cholesterol levels [Blood drawn at baseline, Week 5, Week 9, and Week 12]

    Change in metabolic biomarker (blood levels of HDL and LDL)

  7. Blood leptin levels [Blood drawn at baseline, Week 5, Week 9, and Week 12]

    Change in hunger-related hormones (blood levels of leptin)

  8. Blood ghrelin levels [Blood drawn at baseline, Week 5, Week 9, and Week 12]

    Change in hunger-related hormones (blood levels of ghrelin)

  9. Blood PYY levels [Blood drawn at baseline, Week 5, Week 9, and Week 12]

    Change in hunger-related hormones (blood levels of PYY)

  10. Gut microbiota [Baseline, Week 12]

    Stool samples collected for quantification of gut microbiome composition

  11. Neural reactivity to food vs. control stimuli [Baseline, Week 12]

    Task-based fMRI to determine differences in neural reactivity to food vs. control pictures

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 45 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Center for Addiction and Mental Health Toronto Ontario Canada M5S 2S1

Sponsors and Collaborators

  • Centre for Addiction and Mental Health

Investigators

  • Principal Investigator: Bernard Le Foll, MD, PhD, Centre for Addiction and Mental Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT04801641
Other Study ID Numbers:
  • 084/2018
First Posted:
Mar 17, 2021
Last Update Posted:
Mar 9, 2022
Last Verified:
Mar 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 9, 2022