A Pilot Trial of Nabilone for the Treatment of Obesity

Center for Addiction and Mental Health (CAMH)

Status and phase: Terminated; Phase 2

Conditions: Obesity

Treatments: Drug: Placebo; Drug: Nabilone

Study type: Interventional

Funder types: Other

Identifiers

NCT04801641

084/2018

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 25 to 45 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo

Low-Dose Nabilone

Experimental group

Description:

pms-nabilone titrated to 2 mg daily

Treatment:

Drug: Nabilone

High-Dose Nabilone

Experimental group

Description:

pms-nabilone titrated to 6 mg daily

Treatment:

Drug: Nabilone