Placebo
Six placebo capsules taken orally twice daily
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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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2026-04-09
What this record can show
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Registry facts
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
Six placebo capsules taken orally twice daily
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)
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Number of SAEs collected to assess nabilone safety
Population: 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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebo | 6 | 0 | - |
| Low-Dose Nabilone | 5 | 0 | - |
| High-Dose Nabilone | 4 | 0 | - |
Number of dropouts collected to assess feasibility of study design and intervention
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebo | 7 | 3 | - |
| Low-Dose Nabilone | 6 | 2 | - |
| High-Dose Nabilone | 5 | 5 | - |
Change in body weight
Population: 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
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebo | 6 | 112.2 | 16.4 |
| Low-Dose Nabilone | 5 | 114.0 | 25.9 |
| High-Dose Nabilone | 4 | 90.8 | 17.9 |
| Placebo | 6 | 113.9 | 17.7 |
| Low-Dose Nabilone | 5 | 112.8 | 22.9 |
| High-Dose Nabilone | 4 | 90.8 | 17.2 |
| Placebo | 6 | 113.3 | 16.6 |
| Low-Dose Nabilone | 5 | 114.2 | 23.2 |
| High-Dose Nabilone | 4 | 93.8 | 16.7 |
| Placebo | 6 | 113.1 | 17.3 |
| Low-Dose Nabilone | 5 | 113.0 | 22.8 |
| High-Dose Nabilone | 4 | 99.5 | 20.5 |
| Placebo | 6 | 113.4 | 17.2 |
| Low-Dose Nabilone | 5 | 113.4 | 23.1 |
| Placebo | 6 | 117.7 | 17.7 |
| Low-Dose Nabilone | 5 | 111.7 | 22.1 |
| Placebo | 6 | 116.7 | 16.9 |
| Low-Dose Nabilone | 5 | 111.5 | 22.3 |
| Placebo | 6 | 120.8 | 12.2 |
| Low-Dose Nabilone | 5 | 111.2 | 22.2 |
| Placebo | 6 | 124.4 | 15.0 |
| Low-Dose Nabilone | 5 | 111.7 | 22.6 |
| Placebo | 6 | 122.2 | 15.2 |
| Low-Dose Nabilone | 5 | 111.5 | 21.8 |
| Placebo | 6 | 122.1 | 15.1 |
| Low-Dose Nabilone | 5 | 110.9 | 23.0 |
| Placebo | 6 | 123.4 | 16.0 |
| Low-Dose Nabilone | 5 | 110.5 | 21.6 |
| Placebo | 6 | 123.0 | 17.0 |
| Low-Dose Nabilone | 5 | 113.8 | 22.8 |
| Placebo | 6 | 124.5 | 17.6 |
| Low-Dose Nabilone | 5 | 111.5 | 21.7 |
Change in abdominal fat, as measured by abdominal MRI
Population: 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).
Change in metabolic biomarker (blood levels of glucose)
Population: 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
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebo | 6 | 6.5 | 1.3 |
| Low-Dose Nabilone | 5 | 5.9 | 0.6 |
| High-Dose Nabilone | 4 | 5.0 | 0.4 |
| Placebo | 6 | 5.2 | 0.5 |
| Low-Dose Nabilone | 5 | 5.3 | 0.5 |
| Placebo | 6 | 5.6 | 0.9 |
| Low-Dose Nabilone | 5 | 5.4 | 0.2 |
| Placebo | 6 | 5.9 | 1.2 |
| Low-Dose Nabilone | 5 | 5.5 | 0.2 |
Change in metabolic biomarker (blood levels of insulin)
Population: 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)
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebo | 4 | 425.8 | 386.4 |
| Low-Dose Nabilone | 3 | 243.0 | 116.0 |
| High-Dose Nabilone | 3 | 89.7 | 53.4 |
| Placebo | 4 | 174.3 | 200.0 |
| Low-Dose Nabilone | 3 | 76.3 | 40.7 |
| Placebo | 4 | 247.8 | 204.6 |
| Low-Dose Nabilone | 3 | 88.5 | 5.0 |
| Placebo | 4 | 456.3 | 343.8 |
| Low-Dose Nabilone | 3 | 89.7 | 83.4 |
Change in metabolic biomarker (blood triglyceride levels)
Population: 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)
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebo | 4 | 1.5 | 0.8 |
| Low-Dose Nabilone | 3 | 2.1 | 1.2 |
| High-Dose Nabilone | 3 | 2.6 | 0.7 |
| Placebo | 4 | 1.0 | 0.4 |
| Low-Dose Nabilone | 3 | 1.8 | 1.0 |
| Placebo | 4 | 1.5 | 0.6 |
| Low-Dose Nabilone | 3 | 1.1 | 0.9 |
| Placebo | 4 | 1.5 | 0.5 |
| Low-Dose Nabilone | 3 | 1.8 | 0.8 |
Change in metabolic biomarker (blood levels of HDL and LDL \[total cholesterol\])
Population: 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)
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebo | 4 | 4.5 | 1.0 |
| Low-Dose Nabilone | 3 | 4.9 | 0.7 |
| High-Dose Nabilone | 3 | 5.6 | 0.06 |
| Placebo | 4 | 4.5 | 0.9 |
| Low-Dose Nabilone | 3 | 4.6 | 0.6 |
| Placebo | 4 | 4.8 | 0.9 |
| Low-Dose Nabilone | 3 | 4.0 | 0.1 |
| Placebo | 4 | 4.9 | 0.9 |
| Low-Dose Nabilone | 3 | 4.5 | 0.5 |
Change in hunger-related hormones (blood levels of leptin)
Population: Blood samples were lost in an unfortunate shipment mistake; no data was salvageable
Change in hunger-related hormones (blood levels of ghrelin)
Population: Blood samples were lost in an unfortunate shipment mistake; no data was salvageable
Change in hunger-related hormones (blood levels of PYY)
Population: Blood samples were lost in an unfortunate shipment mistake; no data was salvageable
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.
Population: 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)
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Placebo | 4 | 0.238556962 | 0.034479085 |
| Low-Dose Nabilone | 5 | 0.405623381 | 0.104184176 |
Task-based fMRI to determine differences in neural reactivity to food vs. control pictures
Population: Participation in the imaging procedures in this trial was optional; no participants have data for any imaging measures
| Milestone | Placebo | Low-Dose Nabilone | High-Dose Nabilone |
|---|---|---|---|
| STARTED | 7 | 6 | 5 |
| COMPLETED | 4 | 4 | 0 |
| NOT COMPLETED | 3 | 2 | 5 |
| Event | System | Groups: affected / at risk |
|---|---|---|
| Dry mouth | General disorders | Placebo: 3 / 6 · Low-Dose Nabilone: 5 / 5 · High-Dose Nabilone: 3 / 4 |
| Drowsiness | Nervous system disorders | Placebo: 0 / 6 · Low-Dose Nabilone: 3 / 5 · High-Dose Nabilone: 4 / 4 |
| Increased appetite | Nervous system disorders | Placebo: 2 / 6 · Low-Dose Nabilone: 2 / 5 · High-Dose Nabilone: 3 / 4 |
| Decreased appetite | Nervous system disorders | Placebo: 2 / 6 · Low-Dose Nabilone: 3 / 5 · High-Dose Nabilone: 1 / 4 |
| Dizziness | Nervous system disorders | Placebo: 0 / 6 · Low-Dose Nabilone: 3 / 5 · High-Dose Nabilone: 3 / 4 |
| Headache | Nervous system disorders | Placebo: 1 / 6 · Low-Dose Nabilone: 1 / 5 · High-Dose Nabilone: 2 / 4 |
| Insomnia | Nervous system disorders | Placebo: 2 / 6 · Low-Dose Nabilone: 2 / 5 · High-Dose Nabilone: 0 / 4 |
| Intoxication | Nervous system disorders | Placebo: 0 / 6 · Low-Dose Nabilone: 1 / 5 · High-Dose Nabilone: 3 / 4 |
| Lightheadedness | Nervous system disorders | Placebo: 1 / 6 · Low-Dose Nabilone: 2 / 5 · High-Dose Nabilone: 1 / 4 |
| Diarrhea | Gastrointestinal disorders | Placebo: 0 / 6 · Low-Dose Nabilone: 2 / 5 · High-Dose Nabilone: 1 / 4 |
| Nausea | Gastrointestinal disorders | Placebo: 1 / 6 · Low-Dose Nabilone: 1 / 5 · High-Dose Nabilone: 1 / 4 |
| Constipation | Gastrointestinal disorders | Placebo: 0 / 6 · Low-Dose Nabilone: 1 / 5 · High-Dose Nabilone: 1 / 4 |
| Difficulty concentrating | Nervous system disorders | Placebo: 0 / 6 · Low-Dose Nabilone: 2 / 5 · High-Dose Nabilone: 0 / 4 |
| Anxiety | Psychiatric disorders | Placebo: 0 / 6 · Low-Dose Nabilone: 1 / 5 · High-Dose Nabilone: 0 / 4 |
| Back pain | Musculoskeletal and connective tissue disorders | Placebo: 0 / 6 · Low-Dose Nabilone: 1 / 5 · High-Dose Nabilone: 0 / 4 |
| Blurred vision | Eye disorders | Placebo: 0 / 6 · Low-Dose Nabilone: 1 / 5 · High-Dose Nabilone: 0 / 4 |
| Dry throat | General disorders | Placebo: 1 / 6 · Low-Dose Nabilone: 0 / 5 · High-Dose Nabilone: 0 / 4 |
| Fast heartbeat | Cardiac disorders | Placebo: 1 / 6 · Low-Dose Nabilone: 0 / 5 · High-Dose Nabilone: 0 / 4 |
| Frequent urination | Renal and urinary disorders | Placebo: 0 / 6 · Low-Dose Nabilone: 0 / 5 · High-Dose Nabilone: 1 / 4 |
| Loss of appetite | Nervous system disorders | Placebo: 0 / 6 · Low-Dose Nabilone: 1 / 5 · High-Dose Nabilone: 0 / 4 |
| Menarche (unexpected period) | Reproductive system and breast disorders | Placebo: 0 / 6 · Low-Dose Nabilone: 0 / 5 · High-Dose Nabilone: 1 / 4 |
| Muscle weakness | Musculoskeletal and connective tissue disorders | Placebo: 1 / 6 · Low-Dose Nabilone: 0 / 5 · High-Dose Nabilone: 0 / 4 |
| Nightmares | Psychiatric disorders | Placebo: 0 / 6 · Low-Dose Nabilone: 0 / 5 · High-Dose Nabilone: 1 / 4 |
| Poor memory | Nervous system disorders | Placebo: 0 / 6 · Low-Dose Nabilone: 1 / 5 · High-Dose Nabilone: 0 / 4 |
| Shakiness | General disorders | Placebo: 1 / 6 · Low-Dose Nabilone: 0 / 5 · High-Dose Nabilone: 0 / 4 |
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Placebo: 1 / 6 · Low-Dose Nabilone: 0 / 5 · High-Dose Nabilone: 0 / 4 |
Eligibility
primary outcomes
Time frame: 12 weeks of treatment
Number of SAEs collected to assess nabilone safety
Time frame: 12 weeks of treatment
Number of dropouts collected to assess feasibility of study design and intervention
secondary outcomes
Time frame: Baseline, one weekly visit for Weeks 1-12, then one discharge visit (Week 13)
Change in body weight
Time frame: One scan at baseline and one scan at Week 12
Change in abdominal fat, as measured by abdominal MRI
Time frame: Blood drawn at baseline, Week 5, Week 9, and Week 12
Change in metabolic biomarker (blood levels of glucose)
Time frame: Blood drawn at baseline, Week 5, Week 9, and Week 12
Change in metabolic biomarker (blood levels of insulin)
Time frame: Blood drawn at baseline, Week 5, Week 9, and Week 12
Change in metabolic biomarker (blood triglyceride levels)
Time frame: Blood drawn at baseline, Week 5, Week 9, and Week 12
Change in metabolic biomarker (blood levels of HDL and LDL \[total cholesterol\])
Time frame: Blood drawn at baseline, Week 5, Week 9, and Week 12
Change in hunger-related hormones (blood levels of leptin)
Time frame: Blood drawn at baseline, Week 5, Week 9, and Week 12
Change in hunger-related hormones (blood levels of ghrelin)
Time frame: Blood drawn at baseline, Week 5, Week 9, and Week 12
Change in hunger-related hormones (blood levels of PYY)
Time frame: Baseline, Week 12
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.
Time frame: Baseline, Week 12
Task-based fMRI to determine differences in neural reactivity to food vs. control pictures
Publications
No exact PMID-linked public article is currently readable locally.