Trial Outcomes & Findings for Effects of Citicoline on Brain Function and Behavior in Marijuana-Dependent Individuals (NCT NCT00158249)

NCT ID: NCT00158249

Last Updated: 2014-10-22

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

21 participants

Primary outcome timeframe

Measured for 8 weeks of treatment

Results posted on

2014-10-22

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo matched capsules placebo: matched for physical appearance	Citicoline 2 gm/day citicoline: 2 gm/day, 8 weeks treatment
Overall Study STARTED	11	10
Overall Study COMPLETED	9	10
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=11 Participants matched capsules placebo: matched for physical appearance	Citicoline n=10 Participants 2 gm/day citicoline: 2 gm/day, 8 weeks treatment	Total n=21 Participants Total of all reporting groups
Age, Continuous	30.4 years STANDARD_DEVIATION 7.2 • n=99 Participants	27.7 years STANDARD_DEVIATION 6.9 • n=107 Participants	29.0 years STANDARD_DEVIATION 7.0 • n=206 Participants
Sex: Female, Male Female	3 Participants n=99 Participants	0 Participants n=107 Participants	3 Participants n=206 Participants
Sex: Female, Male Male	8 Participants n=99 Participants	10 Participants n=107 Participants	18 Participants n=206 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Asian	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race (NIH/OMB) Black or African American	7 Participants n=99 Participants	4 Participants n=107 Participants	11 Participants n=206 Participants
Race (NIH/OMB) White	3 Participants n=99 Participants	5 Participants n=107 Participants	8 Participants n=206 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants	1 Participants n=107 Participants	2 Participants n=206 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=99 Participants	1 Participants n=107 Participants	3 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	9 Participants n=99 Participants	9 Participants n=107 Participants	18 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment United States	11 participants n=99 Participants	10 participants n=107 Participants	21 participants n=206 Participants

PRIMARY outcome

Timeframe: Measured for 8 weeks of treatment

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants matched capsules placebo: matched for physical appearance	Citicoline n=10 Participants 2 gm/day citicoline: 2 gm/day, 8 weeks treatment
Marijuana Use	2.5 Reported uses per day Standard Error .71	3.9 Reported uses per day Standard Error 1.1

SECONDARY outcome

Timeframe: Before and after 8 weeks of treatment

Multiple Source Interference Test (MSIT)

Outcome measures

Outcome measures
Measure	Placebo n=9 Participants matched capsules placebo: matched for physical appearance	Citicoline n=10 Participants 2 gm/day citicoline: 2 gm/day, 8 weeks treatment
Neurocognitive Function	32.45 Accuracy percent improvement Standard Error 18.8	16.08 Accuracy percent improvement Standard Error 7.9

Adverse Events

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Citicoline

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Placebo n=9 participants at risk matched capsules placebo: matched for physical appearance	Citicoline n=10 participants at risk 2 gm/day citicoline: 2 gm/day, 8 weeks treatment
General disorders Migraine headache	11.1% 1/9 • Number of events 1	0.00% 0/10
Gastrointestinal disorders NAusea/Vomiting	0.00% 0/9	10.0% 1/10 • Number of events 1

Additional Information

Scott E. Lukas, Ph.D.

McLean Hospital

Phone: 617-855-2767

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place