ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    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 
Lost to Follow-up                0                1                6                5 
Withdrawal by Subject                4                1                3                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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

Total Total of all reporting groups

Baseline Measures
   Nabilone Titrated 2 mg Daily (Phase 1)   Placebo (Phase 1)   Nabilone Titrated to 4 mg Daily (Phase 2)   Placebo (Phase 2)   Total 
Overall Participants Analyzed 
[Units: Participants]
 10   8   16   18   52 
Age 
[Units: Years]
Mean (Standard Deviation)
 24.40  (5.17)   28.88  (7.53)   27.81  (6.81)   28.11  (7.26)   27.42  (6.79) 
Sex: Female, Male 
[Units: Participants]
Count of 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) 
[Units: Participants]
Count of 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 
[Units: Ratio]
Mean (Standard Deviation)
 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 
[Units: Inhales per day]
Mean (Standard Deviation)
 50.1  (43.8)   27.1  (13.2)   28.9  (31.8)   16.53  (29.13)   30.52  (33.65) 


  Outcome Measures

1.  Primary:   Change From Baseline in Cannabis Use at 10 Weeks   [ Time Frame: baseline and 10 weeks ]

2.  Primary:   Number of Marijuana Inhales Per Day   [ Time Frame: Week 10 ]

3.  Secondary:   Change From Baseline Neuropsychological Performance at 4 Weeks   [ Time Frame: baseline and 4 weeks ]

4.  Secondary:   Change From Baseline Cannabis Use at 14 Weeks   [ Time Frame: baseline and 14 weeks ]

5.  Secondary:   Change From Baseline in Neuropsychological Performance at 10 Weeks   [ Time Frame: baseline and 10 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

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
e-mail: khill1@bidmc.harvard.edu



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