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Nabilone & Marijuana Addiction

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: NCT01025700
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : February 17, 2011
Sponsor:
Information provided by:
University of British Columbia

Tracking Information
First Submitted Date  ICMJE December 2, 2009
First Posted Date  ICMJE December 3, 2009
Last Update Posted Date February 17, 2011
Study Start Date  ICMJE June 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 2, 2009)
Safety and tolerability to Nabilone
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01025700 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 2, 2009)
Marijuana craving questionnaire
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nabilone & Marijuana Addiction
Official Title  ICMJE A Double-Blind Placebo Control Study on the Use of Nabilone for Outpatient Management of Acute Marijuana Withdrawal
Brief Summary Safety of Nabilone in reducing marijuana craving
Detailed Description Randomized double blind trial into the safety and efficacy of Cesemat for the treatment of marijuana use
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Marijuana Smoking
Intervention  ICMJE Drug: Cesemat
1 mg capsule per day for 21 days
Other Name: Nabilone
Study Arms  ICMJE
  • Experimental: Cesemat
    Intervention: Drug: Cesemat
  • No Intervention: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: December 2, 2009)
35
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 19 years or older
  • History of marijuana use
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01025700
Other Study ID Numbers  ICMJE H08-01999
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shaohua Lu, MD, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shaohua Lu, MD University of British Columbia
PRS Account University of British Columbia
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP