Nabilone
nabilone titrated to 1 mg by mouth twice daily
Nabilone (Cesamet), CSA Drug Code 7379, Schedule II, NDC 0037-1221-50Loading study record…
Loading study record…
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.
Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2018-06-01
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
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.
Linked local records
Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.
Interventions
nabilone titrated to 1 mg by mouth twice daily
Nabilone (Cesamet), CSA Drug Code 7379, Schedule II, NDC 0037-1221-50one placebo capsule by mouth twice daily
Source-reported results
Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.
Quantitative cannabis urine screens (THC-COOH:Creatinine ratio)
Population: 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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Nabilone Titrated 2 mg Daily (Phase 1) | 6 | 268.8 | 183.0 |
| Placebo (Phase 1) | 6 | 286.7 | 349.7 |
| Nabilone Titrated to 4 mg Daily (Phase 2) | 8 | 490.3 | 615.0 |
| Placebo (Phase 2) | 10 | 216.9 | 188.5 |
Average # of marijuana inhales per day during baseline compared to after 10 weeks of treatment.
Population: 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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Nabilone Titrated 2 mg Daily (Phase 1) | 6 | 33.8 | 31.0 |
| Placebo (Phase 1) | 6 | 22.6 | 30.6 |
| Nabilone Titrated to 4 mg Daily (Phase 2) | 8 | 15.8 | 35.6 |
| Placebo (Phase 2) | 10 | 10.6 | 14.6 |
performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner
Population: Due to funding and the principal investigator's change in institutions, this data was not analyzed and is no longer available to the investigator.
quantitative urine screens - Comparing the THC-COOH to creatinine ratio at baseline and at the end of the study (Week 14)
Population: 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.
| Group | N | Value | Spread / interval |
|---|---|---|---|
| Nabilone Titrated 2 mg Daily (Phase 1) | 6 | 524.2 | 466.2 |
| Placebo (Phase 1) | 6 | 326.7 | 403.7 |
| Nabilone Titrated to 4 mg Daily (Phase 2) | 8 | 297.7 | 291.8 |
| Placebo (Phase 2) | 10 | 222 | 186.53 |
performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner
Population: Due to funding and the principal investigator's change in institutions, this data was not analyzed and is no longer available to the investigator.
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
| Milestone | Nabilone Titrated 2 mg Daily (Phase 1) | Placebo (Phase 1) | Nabilone Titrated to 4 mg Daily (Phase 2) | Placebo (Phase 2) |
|---|---|---|---|---|
| STARTED | 10 | 8 | 16 | 18 |
| COMPLETED | 6 | 6 | 7 | 10 |
| NOT COMPLETED | 4 | 2 | 9 | 8 |
Eligibility
primary outcomes
Time frame: baseline and 10 weeks
Quantitative cannabis urine screens (THC-COOH:Creatinine ratio)
Time frame: Week 10
Average # of marijuana inhales per day during baseline compared to after 10 weeks of treatment.
secondary outcomes
Time frame: baseline and 4 weeks
performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner
Time frame: baseline and 14 weeks
quantitative urine screens - Comparing the THC-COOH to creatinine ratio at baseline and at the end of the study (Week 14)
Time frame: baseline and 10 weeks
performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner
Publications
No exact PMID-linked public article is currently readable locally.