Trial Outcomes & Findings for Citicoline Treatment of Methamphetamine Dependence (NCT NCT00950352)

Results Overview

Total Amount of Methamphetamine consumed by the participants after 8-9 weeks of treatment. Methamphetamine was assessed twice weekly.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

104 participants

Primary outcome timeframe

8 weeks, assessed twice weekly starting week1

Results posted on

2015-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	Citicoline 74 subjects with methamphetamine dependence were treated with citicoline for 8-9 weeks. Citicoline: Subjects were given 1g citicoline twice daily for a total of 8-9 weeks.	Placebo 32 subjects with methamphetamine dependence were treated with placebo for 8-9 weeks. Placebo: Subjects were given 1 g of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group.
Overall Study STARTED	72	32
Overall Study COMPLETED	30	21
Overall Study NOT COMPLETED	42	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Citicoline Treatment of Methamphetamine Dependence

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Citicoline n=72 Participants 74 subjects with methamphetamine dependence were treated with citicoline for 8-9 weeks. Citicoline: Subjects were given 1g citicoline twice daily for a total of 8-9 weeks.	Placebo n=32 Participants 32 subjects with methamphetamine dependence were treated with citicoline for 8-9 weeks. Placebo: Subjects were given 1 capsule of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group.	Total n=104 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	72 Participants n=93 Participants	32 Participants n=4 Participants	104 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	32.9 years STANDARD_DEVIATION 6.8 • n=93 Participants	31.4 years STANDARD_DEVIATION 7.1 • n=4 Participants	32.4 years STANDARD_DEVIATION 6.89 • n=27 Participants
Sex: Female, Male Female	33 Participants n=93 Participants	14 Participants n=4 Participants	47 Participants n=27 Participants
Sex: Female, Male Male	39 Participants n=93 Participants	18 Participants n=4 Participants	57 Participants n=27 Participants
Region of Enrollment United States	72 participants n=93 Participants	32 participants n=4 Participants	104 participants n=27 Participants

PRIMARY outcome

Timeframe: 8 weeks, assessed twice weekly starting week1

Total Amount of Methamphetamine consumed by the participants after 8-9 weeks of treatment. Methamphetamine was assessed twice weekly.

Outcome measures

Outcome measures
Measure	Citicoline n=30 Participants Subjects will be given 1g citicoline twice daily for a total of 8-9 weeks.	Placebo n=21 Participants Subjects will be given 1 g of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group.
Methamphetamine Dependent Subjects Treated With Citicoline vs Placebo	0.3025 total amount consumed in grams Standard Deviation 0.16498	0.3850 total amount consumed in grams Standard Deviation 0.34547

SECONDARY outcome

Timeframe: Neuropsychological testing will occur at week 0 and week 8/9

Cognitive measurement tests will be employed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Neuroimaging will occur at week 0 and week 8/9

Phosphorus-31 ((31)P) magnetic resonance spectroscopy (MRS) was used to evaluate changes in mitochondrial high energy phosphates, including phosphocreatine (PCr) and β-nucleoside triphosphate (β-NTP, primarily ATP in brain) levels.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Throughout the course of the study

Self report drug use and mood will be evaluated at each study visit throughout the course of the study. Also, urine samples will be collected twice a week for drugs of abuse testing.

Outcome measures

Outcome data not reported

Adverse Events

Citicoline

Serious events: 2 serious events

Other events: 10 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Citicoline n=72 participants at risk	Placebo n=32 participants at risk
Psychiatric disorders Suicide attempt	1.4% 1/72 • Number of events 1	0.00% 0/32
Infections and infestations Sepsis	1.4% 1/72 • Number of events 1	0.00% 0/32

Other adverse events

Other adverse events
Measure	Citicoline n=72 participants at risk	Placebo n=32 participants at risk
Gastrointestinal disorders Gatsrointestinal symptoms	2.8% 2/72 • Number of events 2	12.5% 4/32 • Number of events 4
General disorders General (Weight loss, Headache, Cold/flu-lie symptoms, fatigue, pulmonary)	8.3% 6/72 • Number of events 6	18.8% 6/32 • Number of events 6
Psychiatric disorders Psychiatric	2.8% 2/72 • Number of events 2	12.5% 4/32 • Number of events 4

Additional Information

Perry Renshaw, MD, PhD, MBA

The Brain Institute of the University of Utah

Phone: 801-587-1216

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place