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| ID | Type | Description | Link |
|---|---|---|---|
| 1K99DA029115-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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Cannabis use disorders are an important public health problem in the United States, but there are no effective medications available to treat these disorders. The investigators intend to test a medication with interesting properties, nabilone, as a treatment for cannabis dependence and to study the relationship of this treatment with the brain using functional MRI brain scans. Nabilone and marijuana have similar effects upon behaviors and the human body, suggesting that nabilone may decrease cannabis withdrawal symptoms while allowing treatment-seeking patients to benefit from behavioral treatments when they are trying to stop using cannabis. The investigators propose to assess the relationship of nabilone, when added to behavioral treatment, on cannabis use patterns in cannabis-dependent patients. The investigators also aim to determine the effects of nabilone on performance on neuropsychological tests and to assess the correlation of neuropsychological performance to brain changes using functional MRI brain scans. The investigators hypothesize that patients receiving nabilone will reduce their use of cannabis more than patients receiving placebo during this 10-week treatment trial.
Cannabis use disorders are an important public health problem in the United States, but no effective pharmacotherapies are available to treat these disorders. The investigators intend to test a novel agonist pharmacotherapy, nabilone, for cannabis dependence and to study the relationship of this treatment with the brain using BOLD fMRI measures. The behavioral and physiological effects of nabilone and Δ9-THC overlap, suggesting that nabilone may ameliorate cannabis withdrawal symptoms while allowing treatment-seeking outpatients to benefit from medical management (MM) sessions when they are trying to stop using cannabis. The investigators propose to assess the relationship of nabilone, when added to MM, on cannabis use patterns in cannabis-dependent patients. The investigators also aim to determine the effects of nabilone on performance on neuropsychological tests and to assess the correlation of neuropsychological performance to brain changes using BOLD fMRI measures.
In this pilot study, subjects will receive either nabilone or placebo in addition to medical management (MM) over a 10-week treatment period. Subjects' responses to neuropsychological testing carried out while the subject is receiving fMRI scans at 3 time points: at baseline, 4 weeks, and 10 weeks. Following treatment completion, subjects will have a follow-up visit at 14 weeks. This pilot study will evaluate the feasibility of nabilone treatment for cannabis dependence and will establish effect sizes for a larger trial in which subjects will receive high-dose nabilone, low-dose nabilone, or placebo in addition to MM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nabilone | Experimental | nabilone titrated to 2 mg daily |
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| Placebo | Placebo Comparator | Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nabilone | Drug | nabilone titrated to 1 mg by mouth twice daily |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Cannabis Use at 10 Weeks | Quantitative cannabis urine screens (THC-COOH:Creatinine ratio) | baseline and 10 weeks |
| Number of Marijuana Inhales Per Day | Average # of marijuana inhales per day during baseline compared to after 10 weeks of treatment. | Week 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline Neuropsychological Performance at 4 Weeks | performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner | baseline and 4 weeks |
| Change From Baseline Cannabis Use at 14 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin P Hill, MD, MHS | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States |
14 potential subjects were screened but did not qualify for Phase 1 and 18 for Phase 2. Reasons included: positive urine screen for opiates or cocaine, lost to follow up after screening visit, withdrew from the study due to time constraints before randomization, met criteria for alcohol dependence or did not test positive for THC urine screen
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| ID | Title | Description |
|---|---|---|
| FG000 | Nabilone Titrated 2 mg Daily (Phase 1) | nabilone titrated to 2 mg daily Nabilone: nabilone titrated to 1 mg by mouth twice daily |
| FG001 | Placebo (Phase 1) | Placebo Placebo: one placebo capsule by mouth twice daily |
| FG002 | Nabilone Titrated to 4 mg Daily (Phase 2) | nabilone titrated to 4 mg daily Nabilone: nabilone titrated to 2 mg by mouth twice daily |
| FG003 | Placebo (Phase 2) | Placebo Placebo: one placebo capsule by mouth twice daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Nabilone Titrated 2 mg Daily (Phase 1) | nabilone titrated to 2 mg daily Nabilone: nabilone titrated to 1 mg by mouth twice daily |
| BG001 | Placebo (Phase 1) | Placebo Placebo: one placebo capsule by mouth twice daily |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Change From Baseline in Cannabis Use at 10 Weeks | Quantitative cannabis urine screens (THC-COOH:Creatinine ratio) | Fewer participants had their THC:creatinine ratios analyzed than were randomized due to a high number of subject drop-out. Any subject who dropped out before completing the 10 weeks of treatment were not analyzed using this measure. | Posted | Mean | Standard Deviation | Ratio | baseline and 10 weeks |
|
Adverse event data was collected from the time the subject was randomized up until the subject's last visit, this encompasses a total of 14 weeks per subject.
During every visit (twice a week) a study staff member would ask the subject if they were experiencing any adverse events from the medication or participation in the study. Furthermore, during the weekly medication management session with the study physician, the physician asked and checked for adverse events as well
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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 | Nabilone Titrated 2 mg Daily (Phase 1) | nabilone titrated to 2 mg daily Nabilone: nabilone titrated to 1 mg by mouth twice daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kevin P. Hill, M.D., M.H.S., Principal Investigator | Beth Israel Deaconess Medical Center | 617 667 1597 | khill1@bidmc.harvard.edu |
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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 | Apr 14, 2017 | Apr 9, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002189 | Marijuana Abuse |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C011941 | nabilone |
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| Placebo | Drug | one placebo capsule by mouth twice daily |
|
quantitative urine screens - Comparing the THC-COOH to creatinine ratio at baseline and at the end of the study (Week 14)
| baseline and 14 weeks |
| Change From Baseline in Neuropsychological Performance at 10 Weeks | performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner | baseline and 10 weeks |
| Withdrawal by Subject |
|
| BG002 | Nabilone Titrated to 4 mg Daily (Phase 2) | nabilone titrated to 4 mg daily Nabilone: nabilone titrated to 2 mg by mouth twice daily |
| BG003 | Placebo (Phase 2) | Placebo Placebo: one placebo capsule by mouth twice daily |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Baseline Urine THC/Creatinine Ratio | Mean | Standard Deviation | Ratio |
|
| Average Number of Inhales of Marijuana Per Day | Mean | Standard Deviation | Inhales per day |
|
| OG002 | Nabilone Titrated to 4 mg Daily (Phase 2) | nabilone titrated to 4 mg daily Nabilone: nabilone titrated to 2 mg by mouth twice daily |
| OG003 | Placebo (Phase 2) | Placebo Placebo: one placebo capsule by mouth twice daily |
|
|
| Primary | Number of Marijuana Inhales Per Day | Average # of marijuana inhales per day during baseline compared to after 10 weeks of treatment. | Fewer participants had their "average number of inhales per day" analyzed than were randomized due to a high number of subject drop-out. Any subject who dropped out before completing the 10 weeks of treatment were not analyzed using this measure. | Posted | Mean | Standard Deviation | Inhales per day | Week 10 |
|
|
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| Secondary | Change From Baseline Neuropsychological Performance at 4 Weeks | performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner | Due to funding and the principal investigator's change in institutions, this data was not analyzed and is no longer available to the investigator. | Posted | baseline and 4 weeks |
|
|
| Secondary | Change From Baseline Cannabis Use at 14 Weeks | quantitative urine screens - Comparing the THC-COOH to creatinine ratio at baseline and at the end of the study (Week 14) | Fewer participants had their THC:creatinine ratios analyzed than were randomized due to a high number of subject drop-out. Any subject who dropped out before completing the 10 weeks of treatment were not analyzed using this measure. | Posted | Mean | Standard Deviation | Ratio | baseline and 14 weeks |
|
|
|
| Secondary | Change From Baseline in Neuropsychological Performance at 10 Weeks | performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner | Due to funding and the principal investigator's change in institutions, this data was not analyzed and is no longer available to the investigator. | Posted | baseline and 10 weeks |
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Placebo (Phase 1) | Placebo Placebo: one placebo capsule by mouth twice daily | 0 | 8 | 0 | 8 | 0 | 8 |
| EG002 | Nabilone Titrated to 4 mg Daily (Phase 2) | nabilone titrated to 4 mg daily Nabilone: nabilone titrated to 2 mg by mouth twice daily | 0 | 16 | 0 | 16 | 0 | 16 |
| EG003 | Placebo (Phase 2) | Placebo Placebo: one placebo capsule by mouth twice daily | 0 | 18 | 0 | 18 | 0 | 18 |
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