Back to results

A Pilot Trial of Nabilone for the Treatment of Obesity

Primary Purpose

Obesity

Status

Recruiting

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Placebo

Nabilone

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

25 Years - 45 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Center for Addiction and Mental HealthRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Low-Dose Nabilone

High-Dose Nabilone

Arm Description

Placebo

pms-nabilone titrated to 2 mg daily

pms-nabilone titrated to 6 mg daily

Outcomes

Primary Outcome Measures

Number of SAEs per treatment arm

Number of SAEs collected to assess nabilone safety

Number of dropouts per treatment arm

Number of dropouts collected to assess feasibility of study design and intervention

Secondary Outcome Measures

Body weight

Change in body weight

Abdominal fat

Change in abdominal fat, as measured by abdominal MRI

Blood glucose levels

Change in metabolic biomarker (blood levels of glucose)

Blood insulin levels

Change in metabolic biomarker (blood levels of insulin)

Blood triglyceride levels

Change in metabolic biomarker (blood triglyceride levels)

Blood cholesterol levels

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

Blood leptin levels

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

Blood ghrelin levels

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

Blood PYY levels

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

Gut microbiota

Stool samples collected for quantification of gut microbiome composition

Neural reactivity to food vs. control stimuli

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

Full Information

NCT ID

NCT04801641

First Posted

March 4, 2021

Last Updated

March 7, 2022

Sponsor

Centre for Addiction and Mental Health

1. Study Identification

Unique Protocol Identification Number

NCT04801641

Brief Title

A Pilot Trial of Nabilone for the Treatment of Obesity

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 17, 2021 (Actual)

Primary Completion Date

May 2023 (Anticipated)

Study Completion Date

May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Low-Dose Nabilone

Arm Type

Experimental

Arm Description

pms-nabilone titrated to 2 mg daily

Arm Title

High-Dose Nabilone

Arm Type

Experimental

Arm Description

pms-nabilone titrated to 6 mg daily

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Six placebo capsules taken orally twice daily

Intervention Type

Drug

Intervention Name(s)

Nabilone

Intervention Description

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)

Primary Outcome Measure Information:

Title

Number of SAEs per treatment arm

Description

Number of SAEs collected to assess nabilone safety

Time Frame

12 weeks of treatment

Title

Number of dropouts per treatment arm

Description

Number of dropouts collected to assess feasibility of study design and intervention

Time Frame

12 weeks of treatment

Secondary Outcome Measure Information:

Title

Body weight

Description

Change in body weight

Time Frame

Baseline, then weekly for 12 weeks of treatment

Title

Abdominal fat

Description

Change in abdominal fat, as measured by abdominal MRI

Time Frame

One scan at baseline and one scan at Week 12

Title

Blood glucose levels

Description

Change in metabolic biomarker (blood levels of glucose)

Time Frame