Clinical trial NCT04801641: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Obesity
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2021-03-17
Enrollment: 24
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of SAEs per treatment arm
timeFrame: 12 weeks of treatment
measure: Number of dropouts per treatment arm
timeFrame: 12 weeks of treatment
Secondary outcomes:
measure: Body weight
timeFrame: Baseline, then weekly for 12 weeks of treatment
measure: Abdominal fat
timeFrame: One scan at baseline and one scan at Week 12
measure: Blood glucose levels
timeFrame: Blood drawn at baseline, Week 5, Week 9, and Week 12
measure: Blood insulin levels
timeFrame: Blood drawn at baseline, Week 5, Week 9, and Week 12
measure: Blood triglyceride levels
timeFrame: Blood drawn at baseline, Week 5, Week 9, and Week 12
measure: Blood cholesterol levels
timeFrame: Blood drawn at baseline, Week 5, Week 9, and Week 12
measure: Blood leptin levels
timeFrame: Blood drawn at baseline, Week 5, Week 9, and Week 12
measure: Blood ghrelin levels
timeFrame: Blood drawn at baseline, Week 5, Week 9, and Week 12
measure: Blood PYY levels
timeFrame: Blood drawn at baseline, Week 5, Week 9, and Week 12
measure: Gut microbiota
timeFrame: Baseline, Week 12
measure: Neural reactivity to food vs. control stimuli
timeFrame: Baseline, Week 12
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Center for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Bernard Le Foll, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: