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Nabilone for Cannabis Dependence: A Pilot Study (NAB CAN)

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ClinicalTrials.gov Identifier: NCT01347762
Recruitment Status : Completed
First Posted : May 4, 2011
Results First Posted : June 1, 2018
Last Update Posted : June 1, 2018
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Kevin P. Hill, MD, MHS, Mclean Hospital

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Cannabis Dependence
Marijuana Dependence
Interventions Drug: Nabilone
Drug: Placebo
Enrollment 84
Recruitment Details  
Pre-assignment Details 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
Arm/Group Title Nabilone Titrated 2 mg Daily (Phase 1) Placebo (Phase 1) Nabilone Titrated to 4 mg Daily (Phase 2) Placebo (Phase 2)
Hide Arm/Group Description

nabilone titrated to 2 mg daily

Nabilone: nabilone titrated to 1 mg by mouth twice daily

Placebo

Placebo: one placebo capsule by mouth twice daily

nabilone titrated to 4 mg daily

Nabilone: nabilone titrated to 2 mg by mouth twice daily

Placebo

Placebo: one placebo capsule by mouth twice daily

Period Title: Overall Study
Started 10 8 16 18
Completed 6 6 7 10
Not Completed 4 2 9 8
Reason Not Completed
Lost to Follow-up             0             1             6             5
Withdrawal by Subject             4             1             3             3
Arm/Group Title Nabilone Titrated 2 mg Daily (Phase 1) Placebo (Phase 1) Nabilone Titrated to 4 mg Daily (Phase 2) Placebo (Phase 2) Total
Hide Arm/Group Description

nabilone titrated to 2 mg daily

Nabilone: nabilone titrated to 1 mg by mouth twice daily

Placebo

Placebo: one placebo capsule by mouth twice daily

nabilone titrated to 4 mg daily

Nabilone: nabilone titrated to 2 mg by mouth twice daily

Placebo

Placebo: one placebo capsule by mouth twice daily

Total of all reporting groups
Overall Number of Baseline Participants 10 8 16 18 52
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 8 participants 16 participants 18 participants 52 participants
24.40  (5.17) 28.88  (7.53) 27.81  (6.81) 28.11  (7.26) 27.42  (6.79)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 16 participants 18 participants 52 participants
Female
3
  30.0%
3
  37.5%
11
  68.8%
11
  61.1%
28
  53.8%
Male
7
  70.0%
5
  62.5%
5
  31.3%
7
  38.9%
24
  46.2%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 8 participants 16 participants 18 participants 52 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
1
   5.6%
1
   1.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
3
  30.0%
2
  25.0%
6
  37.5%
2
  11.1%
13
  25.0%
White
6
  60.0%
6
  75.0%
9
  56.3%
15
  83.3%
36
  69.2%
More than one race
1
  10.0%
0
   0.0%
1
   6.3%
0
   0.0%
2
   3.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Baseline Urine THC/Creatinine Ratio  
Mean (Standard Deviation)
Unit of measure:  Ratio
Number Analyzed 10 participants 8 participants 16 participants 18 participants 52 participants
491.6  (283.0) 458.7  (568.9) 633.2  (728.5) 371.0  (265.4) 489.8  (496.1)
Average Number of Inhales of Marijuana Per Day  
Mean (Standard Deviation)
Unit of measure:  Inhales per day
Number Analyzed 10 participants 8 participants 16 participants 18 participants 52 participants
50.1  (43.8) 27.1  (13.2) 28.9  (31.8) 16.53  (29.13) 30.52  (33.65)
1.Primary Outcome
Title Change From Baseline in Cannabis Use at 10 Weeks
Hide Description Quantitative cannabis urine screens (THC-COOH:Creatinine ratio)
Time Frame baseline and 10 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nabilone Titrated 2 mg Daily (Phase 1) Placebo (Phase 1) Nabilone Titrated to 4 mg Daily (Phase 2) Placebo (Phase 2)
Hide Arm/Group Description:

nabilone titrated to 2 mg daily

Nabilone: nabilone titrated to 1 mg by mouth twice daily

Placebo

Placebo: one placebo capsule by mouth twice daily

nabilone titrated to 4 mg daily

Nabilone: nabilone titrated to 2 mg by mouth twice daily

Placebo

Placebo: one placebo capsule by mouth twice daily

Overall Number of Participants Analyzed 6 6 8 10
Mean (Standard Deviation)
Unit of Measure: Ratio
268.8  (183.0) 286.7  (349.7) 490.3  (615.0) 216.9  (188.5)
2.Primary Outcome
Title Number of Marijuana Inhales Per Day
Hide Description Average # of marijuana inhales per day during baseline compared to after 10 weeks of treatment.
Time Frame Week 10
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nabilone Titrated 2 mg Daily (Phase 1) Placebo (Phase 1) Nabilone Titrated to 4 mg Daily (Phase 2) Placebo (Phase 2)
Hide Arm/Group Description:

nabilone titrated to 2 mg daily

Nabilone: nabilone titrated to 1 mg by mouth twice daily

Placebo

Placebo: one placebo capsule by mouth twice daily

nabilone titrated to 4 mg daily

Nabilone: nabilone titrated to 2 mg by mouth twice daily

Placebo

Placebo: one placebo capsule by mouth twice daily

Overall Number of Participants Analyzed 6 6 8 10
Mean (Standard Deviation)
Unit of Measure: Inhales per day
33.8  (31.0) 22.6  (30.6) 15.8  (35.6) 10.6  (14.6)
3.Secondary Outcome
Title Change From Baseline Neuropsychological Performance at 4 Weeks
Hide Description performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner
Time Frame baseline and 4 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to funding and the principal investigator's change in institutions, this data was not analyzed and is no longer available to the investigator.
Arm/Group Title Nabilone Titrated 2 mg Daily (Phase 1) Placebo (Phase 1) Nabilone Titrated to 4 mg Daily (Phase 2) Placebo (Phase 2)
Hide Arm/Group Description:

nabilone titrated to 2 mg daily

Nabilone: nabilone titrated to 1 mg by mouth twice daily

Placebo

Placebo: one placebo capsule by mouth twice daily

nabilone titrated to 4 mg daily

Nabilone: nabilone titrated to 2 mg by mouth twice daily

Placebo

Placebo: one placebo capsule by mouth twice daily

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Change From Baseline Cannabis Use at 14 Weeks
Hide Description 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 14 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Nabilone Titrated 2 mg Daily (Phase 1) Placebo (Phase 1) Nabilone Titrated to 4 mg Daily (Phase 2) Placebo (Phase 2)
Hide Arm/Group Description:

nabilone titrated to 2 mg daily

Nabilone: nabilone titrated to 1 mg by mouth twice daily

Placebo

Placebo: one placebo capsule by mouth twice daily

nabilone titrated to 4 mg daily

Nabilone: nabilone titrated to 2 mg by mouth twice daily

Placebo

Placebo: one placebo capsule by mouth twice daily

Overall Number of Participants Analyzed 6 6 8 10
Mean (Standard Deviation)
Unit of Measure: Ratio
524.2  (466.2) 326.7  (403.7) 297.7  (291.8) 222  (186.53)
5.Secondary Outcome
Title Change From Baseline in Neuropsychological Performance at 10 Weeks
Hide Description performance on neuropsychological tests administered inside of the fMRI scanner and outside of the fMRI scanner
Time Frame baseline and 10 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Due to funding and the principal investigator's change in institutions, this data was not analyzed and is no longer available to the investigator.
Arm/Group Title Nabilone Titrated 2 mg Daily (Phase 1) Placebo (Phase 1) Nabilone Titrated to 4 mg Daily (Phase 2) Placebo (Phase 2)
Hide Arm/Group Description:

nabilone titrated to 2 mg daily

Nabilone: nabilone titrated to 1 mg by mouth twice daily

Placebo

Placebo: one placebo capsule by mouth twice daily

nabilone titrated to 4 mg daily

Nabilone: nabilone titrated to 2 mg by mouth twice daily

Placebo

Placebo: one placebo capsule by mouth twice daily

Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame 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.
Adverse Event Reporting Description 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
 
Arm/Group Title Nabilone Titrated 2 mg Daily (Phase 1) Placebo (Phase 1) Nabilone Titrated to 4 mg Daily (Phase 2) Placebo (Phase 2)
Hide Arm/Group Description

nabilone titrated to 2 mg daily

Nabilone: nabilone titrated to 1 mg by mouth twice daily

Placebo

Placebo: one placebo capsule by mouth twice daily

nabilone titrated to 4 mg daily

Nabilone: nabilone titrated to 2 mg by mouth twice daily

Placebo

Placebo: one placebo capsule by mouth twice daily

All-Cause Mortality
Nabilone Titrated 2 mg Daily (Phase 1) Placebo (Phase 1) Nabilone Titrated to 4 mg Daily (Phase 2) Placebo (Phase 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/8 (0.00%)   0/16 (0.00%)   0/18 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Nabilone Titrated 2 mg Daily (Phase 1) Placebo (Phase 1) Nabilone Titrated to 4 mg Daily (Phase 2) Placebo (Phase 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/8 (0.00%)   0/16 (0.00%)   0/18 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Nabilone Titrated 2 mg Daily (Phase 1) Placebo (Phase 1) Nabilone Titrated to 4 mg Daily (Phase 2) Placebo (Phase 2)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)   0/8 (0.00%)   0/16 (0.00%)   0/18 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Kevin P. Hill, M.D., M.H.S., Principal Investigator
Organization: Beth Israel Deaconess Medical Center
Phone: 617 667 1597
Responsible Party: Kevin P. Hill, MD, MHS, Mclean Hospital
ClinicalTrials.gov Identifier: NCT01347762     History of Changes
Other Study ID Numbers: 2010-P-000096
1K99DA029115-01 ( U.S. NIH Grant/Contract )
First Submitted: April 26, 2011
First Posted: May 4, 2011
Results First Submitted: May 30, 2018
Results First Posted: June 1, 2018
Last Update Posted: June 1, 2018