NCT00950352

Citicoline Treatment of Methamphetamine Dependence

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: Perry Renshaw · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to determine if citicoline (a nutritional supplement) is effective in helping people reduce their dependence on methamphetamine. The investigators will use neuroimaging to look at the structure and chemical make up of the brain at the start of the study and after 8-9 weeks of treatment of citicoline or placebo.

Detailed description

This is a prospective, randomized, double-blind, placebo-controlled study, in which we will systematically evaluate the therapeutic effects of citicoline, which may both increase dopamine and normalize cognitive and structural deficits in the brains of methamphetamine dependent subjects. Methamphetamine dependent subjects will undergo baseline and repeat cognitive assessments after 8-9 weeks of placebo or oral citicoline as a nutritional supplement. We will also evaluate the chemical and structural changes in brain regions identified by magnetic resonance spectroscopy (MRS), diffusion tension imaging (DTI) and cortical thickness, which in turn are expected to recover after 8-9 weeks of citicoline treatment. Specific brain regions of interest include the prefrontal cortices, temporal cortex, and the caudate/putamen all of which are known to be involved in the pathophysiology of methamphetamine dependence.

Conditions

• Methamphetamine Dependence

Interventions

Type	Name	Description
DRUG	Citicoline	Subjects will be given 1g citicoline twice daily for a total of 8-9 weeks.
DRUG	Placebo	Subjects will be given 1 capsule of placebo twice daily for 8-9 weeks. They will be taking the same quantity as the citicoline group.

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-12-01
• Completion: 2012-12-01
• First posted: 2009-07-31
• Last updated: 2015-02-11
• Results posted: 2015-02-11

Locations

1 site across 1 country: United States