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

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ClinicalTrials.gov Identifier: NCT00158249
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : October 22, 2014
Last Update Posted : October 22, 2014
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by (Responsible Party):
Scott Lukas, Mclean Hospital

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
Enrollment 21
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo Citicoline
Hide Arm/Group Description

matched capsules

placebo: matched for physical appearance

2 gm/day

citicoline: 2 gm/day, 8 weeks treatment

Period Title: Overall Study
Started 11 10
Completed 9 10
Not Completed 2 0
Arm/Group Title Placebo Citicoline Total
Hide Arm/Group Description

matched capsules

placebo: matched for physical appearance

2 gm/day

citicoline: 2 gm/day, 8 weeks treatment

Total of all reporting groups
Overall Number of Baseline Participants 11 10 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 10 participants 21 participants
30.4  (7.2) 27.7  (6.9) 29.0  (7.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
Female
3
  27.3%
0
   0.0%
3
  14.3%
Male
8
  72.7%
10
 100.0%
18
  85.7%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
7
  63.6%
4
  40.0%
11
  52.4%
White
3
  27.3%
5
  50.0%
8
  38.1%
More than one race
1
   9.1%
1
  10.0%
2
   9.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 10 participants 21 participants
Hispanic or Latino
2
  18.2%
1
  10.0%
3
  14.3%
Not Hispanic or Latino
9
  81.8%
9
  90.0%
18
  85.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 10 participants 21 participants
11 10 21
1.Primary Outcome
Title Marijuana Use
Hide Description [Not Specified]
Time Frame Measured for 8 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Citicoline
Hide Arm/Group Description:

matched capsules

placebo: matched for physical appearance

2 gm/day

citicoline: 2 gm/day, 8 weeks treatment

Overall Number of Participants Analyzed 9 10
Mean (Standard Error)
Unit of Measure: Reported uses per day
2.5  (.71) 3.9  (1.1)
2.Secondary Outcome
Title Neurocognitive Function
Hide Description Multiple Source Interference Test (MSIT)
Time Frame Before and after 8 weeks of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Placebo Citicoline
Hide Arm/Group Description:

matched capsules

placebo: matched for physical appearance

2 gm/day

citicoline: 2 gm/day, 8 weeks treatment

Overall Number of Participants Analyzed 9 10
Mean (Standard Error)
Unit of Measure: Accuracy percent improvement
32.45  (18.8) 16.08  (7.9)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo Citicoline
Hide Arm/Group Description

matched capsules

placebo: matched for physical appearance

2 gm/day

citicoline: 2 gm/day, 8 weeks treatment

All-Cause Mortality
Placebo Citicoline
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Placebo Citicoline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/9 (0.00%)      0/10 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo Citicoline
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/9 (11.11%)      1/10 (10.00%)    
Gastrointestinal disorders     
NAusea/Vomiting *  0/9 (0.00%)  0 1/10 (10.00%)  1
General disorders     
Migraine headache *  1/9 (11.11%)  1 0/10 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
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
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