Nabilone for Obesity

Phase-Based Estimates
1
Effectiveness
2
Safety
Center for Addiction and Mental Health, Toronto, Canada
Obesity
Nabilone - Drug
Eligibility
18 - 65
All Sexes
Eligible conditions
Obesity

Study Summary

This study is evaluating whether a drug similar to the active component of cannabis can help reduce weight in people who are obese.

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Treatment Effectiveness

Effectiveness Estimate

1 of 3

Compared to trials

Study Objectives

This trial is evaluating whether Nabilone will improve 2 primary outcomes and 11 secondary outcomes in patients with Obesity. Measurement will happen over the course of Baseline, then weekly for 12 weeks of treatment.

12 weeks of treatment
Number of SAEs per treatment arm
Number of dropouts per treatment arm
Baseline, Week 12
Gut microbiota
Neural reactivity to food vs. control stimuli
Week 12
Body weight
Week 12
Blood PYY levels
Blood cholesterol levels
Blood ghrelin levels
Blood glucose levels
Blood insulin levels
Blood leptin levels
Blood triglyceride levels
Week 12
Abdominal fat

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Compared to trials

Trial Design

3 Treatment Groups

Placebo
Low-Dose Nabilone
Placebo group

This trial requires 60 total participants across 3 different treatment groups

This trial involves 3 different treatments. Nabilone is the primary treatment being studied. Participants will be divided into 2 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 2 and have already been tested with other people.

Low-Dose Nabilone
Drug
pms-nabilone titrated to 2 mg daily
High-Dose Nabilone
Drug
pms-nabilone titrated to 6 mg daily
Placebo
Drug
Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nabilone
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: blood drawn at baseline, week 5, week 9, and week 12
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly blood drawn at baseline, week 5, week 9, and week 12 for reporting.

Closest Location

Center for Addiction and Mental Health - Toronto, Canada

Eligibility Criteria

This trial is for patients born any sex between 18 and 65 years old. There are 4 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
is recommended during treatment and for 1 month after the final dose of ipilimumab For pregnant women and women who may become pregnant: ipilimumab may cause fetal harm show original
The tests for AST, ALT, bilirubin, and kidney function within normal limits during the screening. show original
Adults with a BMI of 30 or higher are considered obese. show original
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)

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is obesity?

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Obesity is generally defined as a body mass index (BMI) ≥ 30 kg/m(2). However, the World Health Organization (WHO) and other organizations have proposed defining obesity as a BMI ≥ 35 kg/m(2).

Unverified Answer

How many people get obesity a year in the United States?

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Estimates of the number of obesity cases in the United States range from 8.8 to 18.2 million. This estimate may be an underestimate because of self-reported cases of obesity or a misclassification of obesity.

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What causes obesity?

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Obesity is commonly associated with chronic diseases (e.g., diabetes), and it is known that obesity itself may be an independent risk factor for chronic diseases. Nevertheless, the causes and risk factors for obese individuals are still elusive. Possible causes of obesity include genetic predisposition, environmental factors, and a complex interplay between these factors. It is likely that at least partly, different genetic alleles in several individuals or particular environments interact to cause obesity.

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What are common treatments for obesity?

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At least one in every five patients with epilepsy has been told to lose weight: as many as 25% in some studies. Many medications are only prescribed as a means to reduce seizure severity and reduce the frequency of seizures. A lack of evidence does not necessarily mean that they are ineffective. There are a myriad of other possible reasons for the increase in the use of medications to treat obesity in epileptic patients. However, more research is needed on the topic.

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What are the signs of obesity?

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The presence of the following symptoms should alert physicians to the possible presence of obesity: abdominal pain, abdominal distension, enlarged liver and spleen, weight loss, increased waist circumference, and decreased thigh circumference.

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Can obesity be cured?

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Obesity cannot currently be considered a treatable illness. With appropriate treatment, a small but appreciable percentage of the population may improve body mass index and lead to improved overall health.

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Is nabilone safe for people?

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In contrast to nylbuphine, which caused significantly less euphoria than placebo in a parallel group study with healthy volunteers, there were no clinically meaningful differences in side effects between nabilone and placebo in this study. Thus this data do not support the hypothesis that nabilone causes euphoria. For this reason, it seems safe to take nabilone.

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Have there been any new discoveries for treating obesity?

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We summarize four new concepts that will affect the development of future innovative non-pharmaceutical treatments for obesity: dieting, gene therapy, stem cells, and lifestyle intervention. We argue that dieting should still be the first-line treatment strategy to decrease body weight for many obese people.

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Who should consider clinical trials for obesity?

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Obesity has become an established medical diagnosis that is now recognized by most of the professional associations in the United States. Clinical trials are being conducted on a variety of drugs to treat and prevent obesity. Physicians, however, are not getting the information they need to fully evaluate the benefits versus the risks as they decide whether to invest time in obesity research.

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Has nabilone proven to be more effective than a placebo?

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Results from a recent paper provides evidence of the efficacy of the cannabinoid nabilone and suggests its usefulness as an adjunct therapy in the management of obesity with comorbid conditions.

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How serious can obesity be?

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There is an association of obesity with an increased risk of mortality and an increased likelihood of major complications (diabetic, coronary, stroke, and sleep apnea) after surgical procedures. This association was seen regardless of age, height, BMI, or waist circumference. Obesity is a predictor of long-term mortality and complications after coronary artery bypass graft surgery.

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Does nabilone improve quality of life for those with obesity?

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Individuals with obesity were able to obtain improvement in the quality of life related to both the physical body and mental body. They felt better equipped to manage their own health, with the help of such a natural and efficacious drug, due to an increase in physical activity.

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