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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00158249
First Posted: September 12, 2005
Last Update Posted: October 22, 2014
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.
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Scott Lukas, Mclean Hospital
Results First Submitted: October 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, 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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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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


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.
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

Total Total of all reporting groups

Baseline Measures
   Placebo   Citicoline   Total 
Overall Participants Analyzed 
[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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Scott Lukas, Mclean Hospital
ClinicalTrials.gov Identifier: NCT00158249     History of Changes
Other Study ID Numbers: NIDA-19238-1
R01DA019238 ( U.S. NIH Grant/Contract )
DPMC ( Other Identifier: NIDA )
R01DA024007 ( U.S. NIH Grant/Contract )
First Submitted: September 8, 2005
First Posted: September 12, 2005
Results First Submitted: October 15, 2014
Results First Posted: October 22, 2014
Last Update Posted: October 22, 2014