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Poor tolerability of medication and no preliminary efficacy
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Placebo |
|
| Low-Dose Nabilone | Experimental | pms-nabilone titrated to 2 mg daily |
|
| High-Dose Nabilone | Experimental | pms-nabilone titrated to 6 mg daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Six placebo capsules taken orally twice daily |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of SAEs Per Treatment Arm | Number of SAEs collected to assess nabilone safety | 12 weeks of treatment |
| Number of Dropouts Per Treatment Arm | Number of dropouts collected to assess feasibility of study design and intervention | 12 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Body Weight | Change in body weight | Baseline, one weekly visit for Weeks 1-12, then one discharge visit (Week 13) |
| Abdominal Fat | Change in abdominal fat, as measured by abdominal MRI |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Le Foll, MD, PhD | Centre for Addiction and Mental Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Addiction and Mental Health | Toronto | Ontario | M5S 2S1 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo Placebo: Six placebo capsules taken orally twice daily |
| FG001 | Low-Dose Nabilone | pms-nabilone titrated to 2 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily |
| FG002 | High-Dose Nabilone | pms-nabilone titrated to 6 mg daily Nabilone: Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline data do not include participants noted as "Withdrew before receiving medication" in the Participant Flow
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo Placebo: Six placebo capsules taken orally twice daily |
| BG001 | Low-Dose Nabilone | pms-nabilone titrated to 2 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of SAEs Per Treatment Arm | Number of SAEs collected to assess nabilone safety | Note that n=1 participant in each arm was randomized but did not actually receive drug (dropped out before the first week of treatment) and thus is not included in the analysis here. | Posted | Count of Participants | Participants | 12 weeks of treatment |
|
Adverse event data were collected over a period of three months for each participant (i.e., while they were enrolled in the trial). There was no additional follow up, unless any participant had an ongoing adverse event at discharge.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo Placebo: Six placebo capsules taken orally twice daily | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bernard Le Foll | Centre for Addiction and Mental Health | 416-535-8501 | 33111 | bernard.lefoll@camh.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 18, 2022 | Sep 27, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C011941 | nabilone |
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| Nabilone |
| Drug |
Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose) |
|
| One scan at baseline and one scan at Week 12 |
| Blood Glucose Levels | Change in metabolic biomarker (blood levels of glucose) | Blood drawn at baseline, Week 5, Week 9, and Week 12 |
| Blood Insulin Levels | Change in metabolic biomarker (blood levels of insulin) | Blood drawn at baseline, Week 5, Week 9, and Week 12 |
| Blood Triglyceride Levels | Change in metabolic biomarker (blood triglyceride levels) | Blood drawn at baseline, Week 5, Week 9, and Week 12 |
| Blood Cholesterol Levels | Change in metabolic biomarker (blood levels of HDL and LDL [total cholesterol]) | Blood drawn at baseline, Week 5, Week 9, and Week 12 |
| Blood Leptin Levels | Change in hunger-related hormones (blood levels of leptin) | Blood drawn at baseline, Week 5, Week 9, and Week 12 |
| Blood Ghrelin Levels | Change in hunger-related hormones (blood levels of ghrelin) | Blood drawn at baseline, Week 5, Week 9, and Week 12 |
| Blood PYY Levels | Change in hunger-related hormones (blood levels of PYY) | Blood drawn at baseline, Week 5, Week 9, and Week 12 |
| Gut Microbiota | Stool samples collected for quantification of gut microbiome composition; outcome measure is change in beta diversity (Bray-Curtis dissimilarity metric) from baseline to Week 12. The Bray-Curtis dissimilarity is bounded between 0 and 1, where 0 means the two sites have the same composition (i.e., pre and post samples share all the species), and 1 means the two sites do not share any species. | Baseline, Week 12 |
| Neural Reactivity to Food vs. Control Stimuli | Task-based fMRI to determine differences in neural reactivity to food vs. control pictures | Baseline, Week 12 |
| BG002 | High-Dose Nabilone | pms-nabilone titrated to 6 mg daily Nabilone: Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose) |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index (BMI) | Mean | Standard Deviation | kg/m^2 |
|
| Body weight | Mean | Standard Deviation | kg |
|
| Waist circumference | Mean | Standard Deviation | cm |
|
| OG002 | High-Dose Nabilone | pms-nabilone titrated to 6 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose) |
|
|
| Primary | Number of Dropouts Per Treatment Arm | Number of dropouts collected to assess feasibility of study design and intervention | Posted | Count of Participants | Participants | 12 weeks of treatment |
|
|
|
| Secondary | Body Weight | Change in body weight | Note that all participants with collected data are included in the analysis; the sample size changes in the Outcome Measure Data Table as participants dropped out at different weeks | Posted | Mean | Standard Deviation | kg | Baseline, one weekly visit for Weeks 1-12, then one discharge visit (Week 13) |
|
|
|
| Secondary | Abdominal Fat | Change in abdominal fat, as measured by abdominal MRI | Participation in the imaging procedures in this trial was optional; no participants have data for any imaging measures (including this measure, which is abdominal MRI). | Posted | Mean | Standard Deviation | One scan at baseline and one scan at Week 12 |
|
|
| Secondary | Blood Glucose Levels | Change in metabolic biomarker (blood levels of glucose) | Note that all participants with collected data are included in the analysis; the sample size changes in the Outcome Measure Data Table as participants dropped out at different weeks | Posted | Mean | Standard Deviation | mmol/L | Blood drawn at baseline, Week 5, Week 9, and Week 12 |
|
|
|
| Secondary | Blood Insulin Levels | Change in metabolic biomarker (blood levels of insulin) | Note that all participants with collected data are included in the analysis; the sample size changes in the Outcome Measure Data Table as participants dropped out at different weeks (for this measure specifically, there was also some missing data from enrolled participants) | Posted | Mean | Standard Deviation | pmol/L | Blood drawn at baseline, Week 5, Week 9, and Week 12 |
|
|
|
| Secondary | Blood Triglyceride Levels | Change in metabolic biomarker (blood triglyceride levels) | Note that all participants with collected data are included in the analysis; the sample size changes in the Outcome Measure Data Table as participants dropped out at different weeks (for this measure specifically, there was also some missing data from enrolled participants) | Posted | Mean | Standard Deviation | mmol/L | Blood drawn at baseline, Week 5, Week 9, and Week 12 |
|
|
|
| Secondary | Blood Cholesterol Levels | Change in metabolic biomarker (blood levels of HDL and LDL [total cholesterol]) | Note that all participants with collected data are included in the analysis; the sample size changes in the Outcome Measure Data Table as participants dropped out at different weeks (for this measure specifically, there was also some missing data from enrolled participants) | Posted | Mean | Standard Deviation | mmol/L | Blood drawn at baseline, Week 5, Week 9, and Week 12 |
|
|
|
| Secondary | Blood Leptin Levels | Change in hunger-related hormones (blood levels of leptin) | Blood samples were lost in an unfortunate shipment mistake; no data was salvageable | Posted | Mean | Standard Deviation | Blood drawn at baseline, Week 5, Week 9, and Week 12 |
|
|
| Secondary | Blood Ghrelin Levels | Change in hunger-related hormones (blood levels of ghrelin) | Blood samples were lost in an unfortunate shipment mistake; no data was salvageable | Posted | Mean | Standard Deviation | Blood drawn at baseline, Week 5, Week 9, and Week 12 |
|
|
| Secondary | Blood PYY Levels | Change in hunger-related hormones (blood levels of PYY) | Blood samples were lost in an unfortunate shipment mistake; no data was salvageable | Posted | Mean | Standard Deviation | Blood drawn at baseline, Week 5, Week 9, and Week 12 |
|
|
| Secondary | Gut Microbiota | Stool samples collected for quantification of gut microbiome composition; outcome measure is change in beta diversity (Bray-Curtis dissimilarity metric) from baseline to Week 12. The Bray-Curtis dissimilarity is bounded between 0 and 1, where 0 means the two sites have the same composition (i.e., pre and post samples share all the species), and 1 means the two sites do not share any species. | Number of participants analyzed reflects participants who returned fecal samples at both baseline and Week 12 visits (with either of these samples missing, it is not possible to calculate a change in beta diversity) | Posted | Mean | Standard Deviation | Proportion | Baseline, Week 12 |
|
|
|
| Secondary | Neural Reactivity to Food vs. Control Stimuli | Task-based fMRI to determine differences in neural reactivity to food vs. control pictures | Participation in the imaging procedures in this trial was optional; no participants have data for any imaging measures | Posted | Mean | Standard Deviation | Baseline, Week 12 |
|
|
| 6 |
| 0 |
| 6 |
| 5 |
| 6 |
| EG001 | Low-Dose Nabilone | pms-nabilone titrated to 2 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose) | 0 | 5 | 0 | 5 | 5 | 5 |
| EG002 | High-Dose Nabilone | pms-nabilone titrated to 6 mg daily Nabilone: Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose) | 0 | 4 | 0 | 4 | 4 | 4 |
| Drowsiness | Nervous system disorders | Systematic Assessment |
|
| Increased appetite | Nervous system disorders | Systematic Assessment |
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| Decreased appetite | Nervous system disorders | Systematic Assessment |
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| Dizziness | Nervous system disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Insomnia | Nervous system disorders | Systematic Assessment |
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| Intoxication | Nervous system disorders | Systematic Assessment |
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| Lightheadedness | Nervous system disorders | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | Systematic Assessment |
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| Difficulty concentrating | Nervous system disorders | Systematic Assessment |
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| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Blurred vision | Eye disorders | Systematic Assessment |
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| Dry throat | General disorders | Systematic Assessment |
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| Fast heartbeat | Cardiac disorders | Systematic Assessment |
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| Frequent urination | Renal and urinary disorders | Systematic Assessment |
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| Loss of appetite | Nervous system disorders | Systematic Assessment |
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| Menarche (unexpected period) | Reproductive system and breast disorders | Systematic Assessment |
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| Muscle weakness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Nightmares | Psychiatric disorders | Systematic Assessment |
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| Poor memory | Nervous system disorders | Systematic Assessment |
|
| Shakiness | General disorders | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
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