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Effects of Citicoline on Brain Function and Behavior in Marijuana-Dependent Individuals

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Scott Lukas, Mclean Hospital
ClinicalTrials.gov Identifier:
NCT00158249
First received: September 8, 2005
Last updated: October 15, 2014
Last verified: October 2014
Results First Received: October 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Marijuana Abuse
Interventions: Drug: citicoline
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
Placebo

matched capsules

placebo: matched for physical appearance

Citicoline

2 gm/day

citicoline: 2 gm/day, 8 weeks treatment


Participant Flow:   Overall Study
    Placebo     Citicoline  
STARTED     11     10  
COMPLETED     9     10  
NOT COMPLETED     2     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.
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Reporting Groups
  Description
Placebo

matched capsules

placebo: matched for physical appearance

Citicoline

2 gm/day

citicoline: 2 gm/day, 8 weeks treatment

Total Total of all reporting groups

Baseline Measures
    Placebo     Citicoline     Total  
Number of Participants  
[units: participants]
  11     10     21  
Age  
[units: years]
Mean ± Standard Deviation
  30.4  ± 7.2     27.7  ± 6.9     29.0  ± 7.0  
Gender  
[units: participants]
     
Female     3     0     3  
Male     8     10     18  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     7     4     11  
White     3     5     8  
More than one race     1     1     2  
Unknown or Not Reported     0     0     0  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     2     1     3  
Not Hispanic or Latino     9     9     18  
Unknown or Not Reported     0     0     0  
Region of Enrollment  
[units: participants]
     
United States     11     10     21  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Marijuana Use   [ Time Frame: Measured for 8 weeks of treatment ]

2.  Secondary:   Neurocognitive Function   [ Time Frame: Before and after 8 weeks of treatment ]


  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
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Scott E. Lukas, Ph.D.
Organization: McLean Hospital
phone: 617-855-2767
e-mail: slukas@mclean.harvard.edu


No publications provided by Mclean Hospital

Publications automatically indexed to this study:

Responsible Party: Scott Lukas, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00158249     History of Changes
Other Study ID Numbers: NIDA-19238-1, R01DA019238, DPMC, R01DA024007
Study First Received: September 8, 2005
Results First Received: October 15, 2014
Last Updated: October 15, 2014
Health Authority: United States: Food and Drug Administration