Status:
TERMINATED
A Pilot Trial of Nabilone for the Treatment of Obesity
Lead Sponsor:
Centre for Addiction and Mental Health
Conditions:
Obesity
Eligibility:
All Genders
25-45 years
Phase:
PHASE2
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, t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 17 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 14 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT04801641
Start Date
September 17 2021
End Date
August 14 2023
Last Update
January 29 2024
Active Locations (1)
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1
Center for Addiction and Mental Health
Toronto, Ontario, Canada, M5S 2S1