Trial Outcomes & Findings for Nabilone for Cannabis Dependence: A Pilot Study (NCT NCT01347762)
NCT ID: NCT01347762
Last Updated: 2018-06-01
Results Overview
Quantitative cannabis urine screens (THC-COOH:Creatinine ratio)
COMPLETED
PHASE2/PHASE3
84 participants
baseline and 10 weeks
2018-06-01
Participant Flow
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
Participant milestones
| Measure |
Nabilone Titrated 2 mg Daily (Phase 1)
nabilone titrated to 2 mg daily
Nabilone: nabilone titrated to 1 mg by mouth twice daily
|
Placebo (Phase 1)
Placebo
Placebo: one placebo capsule by mouth twice daily
|
Nabilone Titrated to 4 mg Daily (Phase 2)
nabilone titrated to 4 mg daily
Nabilone: nabilone titrated to 2 mg by mouth twice daily
|
Placebo (Phase 2)
Placebo
Placebo: one placebo capsule by mouth twice daily
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
10
|
8
|
16
|
18
|
|
Overall Study
COMPLETED
|
6
|
6
|
7
|
10
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
9
|
8
|
Reasons for withdrawal
| Measure |
Nabilone Titrated 2 mg Daily (Phase 1)
nabilone titrated to 2 mg daily
Nabilone: nabilone titrated to 1 mg by mouth twice daily
|
Placebo (Phase 1)
Placebo
Placebo: one placebo capsule by mouth twice daily
|
Nabilone Titrated to 4 mg Daily (Phase 2)
nabilone titrated to 4 mg daily
Nabilone: nabilone titrated to 2 mg by mouth twice daily
|
Placebo (Phase 2)
Placebo
Placebo: one placebo capsule by mouth twice daily
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
6
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
3
|
3
|
Baseline Characteristics
Nabilone for Cannabis Dependence: A Pilot Study
Baseline characteristics by cohort
| Measure |
Nabilone Titrated 2 mg Daily (Phase 1)
n=10 Participants
nabilone titrated to 2 mg daily
Nabilone: nabilone titrated to 1 mg by mouth twice daily
|
Placebo (Phase 1)
n=8 Participants
Placebo
Placebo: one placebo capsule by mouth twice daily
|
Nabilone Titrated to 4 mg Daily (Phase 2)
n=16 Participants
nabilone titrated to 4 mg daily
Nabilone: nabilone titrated to 2 mg by mouth twice daily
|
Placebo (Phase 2)
n=18 Participants
Placebo
Placebo: one placebo capsule by mouth twice daily
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
24.40 years
STANDARD_DEVIATION 5.17 • n=93 Participants
|
28.88 years
STANDARD_DEVIATION 7.53 • n=4 Participants
|
27.81 years
STANDARD_DEVIATION 6.81 • n=27 Participants
|
28.11 years
STANDARD_DEVIATION 7.26 • n=483 Participants
|
27.42 years
STANDARD_DEVIATION 6.79 • n=36 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
11 Participants
n=483 Participants
|
28 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
24 Participants
n=36 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
6 Participants
n=27 Participants
|
2 Participants
n=483 Participants
|
13 Participants
n=36 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=27 Participants
|
15 Participants
n=483 Participants
|
36 Participants
n=36 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
|
Baseline Urine THC/Creatinine Ratio
|
491.6 Ratio
STANDARD_DEVIATION 283.0 • n=93 Participants
|
458.7 Ratio
STANDARD_DEVIATION 568.9 • n=4 Participants
|
633.2 Ratio
STANDARD_DEVIATION 728.5 • n=27 Participants
|
371.0 Ratio
STANDARD_DEVIATION 265.4 • n=483 Participants
|
489.8 Ratio
STANDARD_DEVIATION 496.1 • n=36 Participants
|
|
Average Number of Inhales of Marijuana Per Day
|
50.1 Inhales per day
STANDARD_DEVIATION 43.8 • n=93 Participants
|
27.1 Inhales per day
STANDARD_DEVIATION 13.2 • n=4 Participants
|
28.9 Inhales per day
STANDARD_DEVIATION 31.8 • n=27 Participants
|
16.53 Inhales per day
STANDARD_DEVIATION 29.13 • n=483 Participants
|
30.52 Inhales per day
STANDARD_DEVIATION 33.65 • n=36 Participants
|
PRIMARY outcome
Timeframe: baseline and 10 weeksPopulation: 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.
Quantitative cannabis urine screens (THC-COOH:Creatinine ratio)
Outcome measures
| Measure |
Nabilone Titrated 2 mg Daily (Phase 1)
n=6 Participants
nabilone titrated to 2 mg daily
Nabilone: nabilone titrated to 1 mg by mouth twice daily
|
Placebo (Phase 1)
n=6 Participants
Placebo
Placebo: one placebo capsule by mouth twice daily
|
Nabilone Titrated to 4 mg Daily (Phase 2)
n=8 Participants
nabilone titrated to 4 mg daily
Nabilone: nabilone titrated to 2 mg by mouth twice daily
|
Placebo (Phase 2)
n=10 Participants
Placebo
Placebo: one placebo capsule by mouth twice daily
|
|---|---|---|---|---|
|
Change From Baseline in Cannabis Use at 10 Weeks
|
268.8 Ratio
Standard Deviation 183.0
|
286.7 Ratio
Standard Deviation 349.7
|
490.3 Ratio
Standard Deviation 615.0
|
216.9 Ratio
Standard Deviation 188.5
|
PRIMARY outcome
Timeframe: Week 10Population: 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.
Average # of marijuana inhales per day during baseline compared to after 10 weeks of treatment.
Outcome measures
| Measure |
Nabilone Titrated 2 mg Daily (Phase 1)
n=6 Participants
nabilone titrated to 2 mg daily
Nabilone: nabilone titrated to 1 mg by mouth twice daily
|
Placebo (Phase 1)
n=6 Participants
Placebo
Placebo: one placebo capsule by mouth twice daily
|
Nabilone Titrated to 4 mg Daily (Phase 2)
n=8 Participants
nabilone titrated to 4 mg daily
Nabilone: nabilone titrated to 2 mg by mouth twice daily
|
Placebo (Phase 2)
n=10 Participants
Placebo
Placebo: one placebo capsule by mouth twice daily
|
|---|---|---|---|---|
|
Number of Marijuana Inhales Per Day
|
33.8 Inhales per day
Standard Deviation 31.0
|
22.6 Inhales per day
Standard Deviation 30.6
|
15.8 Inhales per day
Standard Deviation 35.6
|
10.6 Inhales per day
Standard Deviation 14.6
|
SECONDARY outcome
Timeframe: baseline and 4 weeksPopulation: Due to funding and the principal investigator's change in institutions, this data was not analyzed and is no longer available to the investigator.
performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: baseline and 14 weeksPopulation: 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.
quantitative urine screens - Comparing the THC-COOH to creatinine ratio at baseline and at the end of the study (Week 14)
Outcome measures
| Measure |
Nabilone Titrated 2 mg Daily (Phase 1)
n=6 Participants
nabilone titrated to 2 mg daily
Nabilone: nabilone titrated to 1 mg by mouth twice daily
|
Placebo (Phase 1)
n=6 Participants
Placebo
Placebo: one placebo capsule by mouth twice daily
|
Nabilone Titrated to 4 mg Daily (Phase 2)
n=8 Participants
nabilone titrated to 4 mg daily
Nabilone: nabilone titrated to 2 mg by mouth twice daily
|
Placebo (Phase 2)
n=10 Participants
Placebo
Placebo: one placebo capsule by mouth twice daily
|
|---|---|---|---|---|
|
Change From Baseline Cannabis Use at 14 Weeks
|
524.2 Ratio
Standard Deviation 466.2
|
326.7 Ratio
Standard Deviation 403.7
|
297.7 Ratio
Standard Deviation 291.8
|
222 Ratio
Standard Deviation 186.53
|
SECONDARY outcome
Timeframe: baseline and 10 weeksPopulation: Due to funding and the principal investigator's change in institutions, this data was not analyzed and is no longer available to the investigator.
performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner
Outcome measures
Outcome data not reported
Adverse Events
Nabilone Titrated 2 mg Daily (Phase 1)
Placebo (Phase 1)
Nabilone Titrated to 4 mg Daily (Phase 2)
Placebo (Phase 2)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kevin P. Hill, M.D., M.H.S., Principal Investigator
Beth Israel Deaconess Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place