A Pilot Trial of Nabilone for the Treatment of Obesity

NCT04801641 | Terminated Phase 2 Results

• 1 other identifier: 084/2018
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Outcome Measures

Primary Outcomes (2)

• Number of SAEs Per Treatment Arm

  Number of SAEs collected to assess nabilone safety

  12 weeks of treatment

• Number of Dropouts Per Treatment Arm

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

  12 weeks of treatment

Secondary Outcomes (11)

• Body Weight

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

• Abdominal Fat

  One scan at baseline and one scan at Week 12

• Blood Glucose Levels

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

• Blood Insulin Levels

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

• Blood Triglyceride Levels

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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Low-Dose Nabilone

EXPERIMENTAL

pms-nabilone titrated to 2 mg daily

Drug: Nabilone

High-Dose Nabilone

EXPERIMENTAL

pms-nabilone titrated to 6 mg daily

Drug: Nabilone

Interventions

Placebo DRUG

Six placebo capsules taken orally twice daily

Placebo

Nabilone DRUG

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)

High-Dose Nabilone; Low-Dose Nabilone

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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:

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Center for Addiction and Mental Health

Toronto, Ontario, M5S 2S1, Canada

Location

MeSH Terms

Conditions

Obesity

Interventions

nabilone

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Bernard Le Foll
• Organization: Centre for Addiction and Mental Health

bernard.lefoll@camh.ca

416-535-8501

Study Officials

• Bernard Le Foll, MD, PhD

  Centre for Addiction and Mental Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 17, 2021
• Study Start: September 17, 2021
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: April 9, 2026
• Results First Posted: April 9, 2026

Record last verified: 2024-09

Locations

CA (1)