Fixed or Self-Titrated Dosages of Sativex on Cannabis Users

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Bernard Le Foll, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier:
NCT01748799
First received: December 8, 2012
Last updated: December 30, 2015
Last verified: October 2015
Results First Received: August 14, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Cannabis Dependence
Interventions: Drug: Sativex
Drug: Placebo

  Participant Flow
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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
No text entered.

Reporting Groups
  Description
Sequence 1 Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
Sequence 2 Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
Sequence 3 Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
Sequence 4 Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
Sequence 5 Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
Sequence 6 Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
Sequence 7 Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
Sequence 8 Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo

Participant Flow:   Overall Study
    Sequence 1     Sequence 2     Sequence 3     Sequence 4     Sequence 5     Sequence 6     Sequence 7     Sequence 8  
STARTED     6     1     1     2     1     2     2     1  
Completed SAU of Fixed Dose Placebo     2     1     1     2     1     1     1     1  
Completed Fixed Dose Placebo     2     1     1     2     1     1     1     1  
Completed SAU of Fixed Dose Sativex     1     1     1     2     1     1     1     1  
Completed Fixed Dose Sativex     1     1     1     2     1     1     1     1  
Completed SAU of Self-titrated Placebo     5     1     1     2     1     2     1     1  
Completed Self-titrated Placebo     4     1     1     2     1     2     1     1  
Completed SAU of Self-titrated Sativex     2     1     1     2     1     2     1     1  
Completed Self-titrated Sativex     1     1     1     2     1     1     1     1  
COMPLETED     1     1     1     2     1     1     1     1  
NOT COMPLETED     5     0     0     0     0     1     1     0  



  Baseline Characteristics
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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
Sequence 1 Self-titrated placebo - Self-titrated Sativex - Fixed dose Sativex - Fixed dose placebo
Sequence 2 Fixed dose placebo - Fixed dose Sativex - Self-titrated Sativex - Self-titrated placebo
Sequence 3 Fixed dose placebo - Fixed dose Sativex - Self-titrated placebo - Self-titrated Sativex
Sequence 4 Fixed dose Sativex - Fixed dose placebo - Self-titrated placebo - Self-titrated Sativex
Sequence 5 Self-titrated Sativex - Self-titrated placebo - Fixed dose Sativex - Fixed dose placebo
Sequence 6 Self-titrated Sativex - Self-titrated placebo - Fixed dose placebo - Fixed dose Sativex
Sequence 7 Self-titrated placebo - Self-titrated Sativex - Fixed dose placebo - Fixed dose Sativex
Sequence 8 Fixed dose Sativex - Fixed dose placebo - Self-titrated Sativex - Self-titrated placebo
Total Total of all reporting groups

Baseline Measures
    Sequence 1     Sequence 2     Sequence 3     Sequence 4     Sequence 5     Sequence 6     Sequence 7     Sequence 8     Total  
Number of Participants  
[units: participants]
  6     1     1     2     1     2     2     1     16  
Age  
[units: years]
Mean (Standard Deviation)
  35.7  (8.6)     24.0  (0.0)     19.0  (0.0)     46.5  (6.4)     36.0  (0.0)     41.5  (6.4)     43.0  (5.6)     22.0  (0.0)     34.8  (10.5)  
Gender  
[units: participants]
                 
Female     2     1     0     0     0     0     1     0     4  
Male     4     0     1     2     1     2     1     1     12  
Region of Enrollment  
[units: participants]
                 
Canada     6     1     1     2     1     2     2     1     16  



  Outcome Measures
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1.  Primary:   Feasibility   [ Time Frame: 12 months ]

2.  Secondary:   Tolerability of Sativex in Persons That Are Cannabis Dependent   [ Time Frame: 8 weeks ]

3.  Secondary:   Cannabis Withdrawal   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
The main limitation is the small sample size. Also our study did not include experimental conditions containing THC alone and CBD alone for comparison. The short duration of the experimental condition is also a limitation.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Bernard Le Foll
Organization: Centre for Addiction and Mental Health (CAMH)
phone: 416.535.8501 ext 34772
e-mail: bernard.lefoll@camh.ca


No publications provided


Responsible Party: Bernard Le Foll, Centre for Addiction and Mental Health
ClinicalTrials.gov Identifier: NCT01748799     History of Changes
Other Study ID Numbers: 103/2011
243152 ( Other Grant/Funding Number: Canadian Institutes of Health Research )
Study First Received: December 8, 2012
Results First Received: August 14, 2015
Last Updated: December 30, 2015
Health Authority: Canada: Health Canada