TerminatedPhase 2

A Pilot Trial of Nabilone for the Treatment of Obesity

Stopped: Poor tolerability of medication and no preliminary efficacy

Canada18 participantsStarted 2021-09-17

Plain-language 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.

Who can participate

Age range25 Years – 45 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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, *…

What they're measuring

Number of SAEs Per Treatment Arm

Timeframe: 12 weeks of treatment

Number of Dropouts Per Treatment Arm

Timeframe: 12 weeks of treatment

Trial details

NCT IDNCT04801641

SponsorCentre for Addiction and Mental Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-14

Results submitted2024-09-30