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ObesityPhase 2NCT04801641

A Pilot Trial of Nabilone for the Treatment of Obesity

A Phase 2 study testing Nabilone in people with Obesity, run by Centre for Addiction and Mental Health at 1 site in Canada.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 25 to 45 years
Conditions the study is for
Obesity
What is being tested?
Nabilone
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteCanada
Study dates
17 Sep 2021to 14 Aug 2023
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 45 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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,
Show all 18Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Center for Addiction and Mental Health

    Toronto, Ontario, M5S 2S1

Other trials in Canada

About this study

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

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.

Conditions
Obesity
Being tested
Placebo, Nabilone
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboDrug

    Six placebo capsules taken orally twice daily

  • NabiloneDrug

    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)

Study groups in NCT04801641
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo
Low-Dose NabiloneExperimentalpms-nabilone titrated to 2 mg daily
Receives: Drug: Nabilone
High-Dose NabiloneExperimentalpms-nabilone titrated to 6 mg daily
Receives: Drug: Nabilone

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of SAEs Per Treatment Arm

    Number of SAEs collected to assess nabilone safety

    Measured: 12 weeks of treatment

  2. Number of Dropouts Per Treatment Arm

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

    Measured: 12 weeks of treatment

Secondary outcomes (11)

  1. Body Weight

    Change in body weight

    Measured: Baseline, one weekly visit for Weeks 1-12, then one discharge visit (Week 13)

  2. Abdominal Fat

    Change in abdominal fat, as measured by abdominal MRI

    Measured: One scan at baseline and one scan at Week 12

  3. Blood Glucose Levels

    Change in metabolic biomarker (blood levels of glucose)

    Measured: Blood drawn at baseline, Week 5, Week 9, and Week 12

  4. Blood Insulin Levels

    Change in metabolic biomarker (blood levels of insulin)

    Measured: Blood drawn at baseline, Week 5, Week 9, and Week 12

  5. Blood Triglyceride Levels

    Change in metabolic biomarker (blood triglyceride levels)

    Measured: Blood drawn at baseline, Week 5, Week 9, and Week 12

  6. Blood Cholesterol Levels

    Change in metabolic biomarker (blood levels of HDL and LDL [total cholesterol])

    Measured: Blood drawn at baseline, Week 5, Week 9, and Week 12

  7. Blood Leptin Levels

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

    Measured: Blood drawn at baseline, Week 5, Week 9, and Week 12

  8. Blood Ghrelin Levels

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

    Measured: Blood drawn at baseline, Week 5, Week 9, and Week 12

  9. Blood PYY Levels

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

    Measured: Blood drawn at baseline, Week 5, Week 9, and Week 12

  10. 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.

    Measured: Baseline, Week 12

  11. Neural Reactivity to Food vs. Control Stimuli

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

    Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Mar 2021
  2. Study start17 Sep 2021
  3. Primary completion14 Aug 2023
  4. Study completion14 Aug 2023

Why it stopped: Poor tolerability of medication and no preliminary efficacy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04801641
Sponsor's protocol ID
084/2018
Status last verified
Sep 2024
First submitted
4 Mar 2021
Last updated
9 Apr 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Matheson J, Tertigas D, Malik S, Taylor V, Chavez S, Sharkey KA, Silvestri C, Surette M, Le Foll B. Feasibility and Tolerability of Nabilone for the Treatment of Obesity: A Randomized Controlled Pilot Trial. Cannabis Cannabinoid Res. 2025 Oct;10(5):640-651. doi: 10.1089/can.2025.0034. Epub 2025 May 12.

    PubMed 40353878

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Nabilone in people with Obesity, run by Centre for Addiction and Mental Health at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of SAEs Per Treatment Arm (time frame: 12 weeks of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04801641, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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