Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00158249
Status:
COMPLETED
Last Update Posted:
2014-10-22
First Post:
2005-09-08
Brief Title:
Effects of Citicoline on Brain Function and Behavior in Marijuana-Dependent Individuals
Sponsor:
Mclean Hospital
Organization:
Mclean Hospital
Study Overview
Official Title:
Cannabis Dependence Imaging and Medication Development - 1
Status:
COMPLETED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The Three Aims of this study are only studies for Aim 1 were completed
1 Measure the impact of citicoline on marihuana use patterns in subjects individualized natural settings and responses to marihuana challenge using functional brain MRI scans
Hypothesis - 2 gday citicoline will produce greater reductions in marihuana use and craving in heavy marihuana users than placebo citicoline over a 8-week treatment period as measured in their natural environments The same participants will experience greater improved brain activation patterns and an improvement in cognitive functioning compared to placebo controlled subjects
2 Measure the effects of citicoline on marihuana absorption and metabolism and determine if these changes parallel changes in subjective and physiological responses in a laboratory setting
Hypothesis - Chronic 8 weeks treatment with 2 gday citicoline will produce increases in subjective and physiological effects of both acute marihuana smoking and placebo marihuana smoking compared to chronic placebo citicoline Citicoline will have no effect on marihuana pharmacokinetics
3 Measure the effects of citicoline on marijuana-induced cue-induced craving and brain electrical activity EEG
Hypothesis - Chronic 8 weeks treatment with 2 gday citicoline will reduce objective measures of marijuana cue-reactivity and subjective reports of craving in response to marihuana cues will also be attenuated compared to chronic placebo citicoline treatment
1 Measure the impact of citicoline on marihuana use patterns in subjects individualized natural settings and responses to marihuana challenge using functional brain MRI scans
Hypothesis - 2 gday citicoline will produce greater reductions in marihuana use and craving in heavy marihuana users than placebo citicoline over a 8-week treatment period as measured in their natural environments The same participants will experience greater improved brain activation patterns and an improvement in cognitive functioning compared to placebo controlled subjects
2 Measure the effects of citicoline on marihuana absorption and metabolism and determine if these changes parallel changes in subjective and physiological responses in a laboratory setting
Hypothesis - Chronic 8 weeks treatment with 2 gday citicoline will produce increases in subjective and physiological effects of both acute marihuana smoking and placebo marihuana smoking compared to chronic placebo citicoline Citicoline will have no effect on marihuana pharmacokinetics
3 Measure the effects of citicoline on marijuana-induced cue-induced craving and brain electrical activity EEG
Hypothesis - Chronic 8 weeks treatment with 2 gday citicoline will reduce objective measures of marijuana cue-reactivity and subjective reports of craving in response to marihuana cues will also be attenuated compared to chronic placebo citicoline treatment
Detailed Description:
Marijuana dependence is an important public health problem in the United States yet still no effective therapies are available It is unclear how marijuana affects brain function after acute or chronic use Knowing about the changes in brain function during marijuana dependence would aid in the understanding of the neurobiological basis of marijuana abuse and serve as a foundation for the development of new treatment medications for this disorder New and improved brain imaging techniques such as functional MRI fMRI and magnetic resonance spectroscopy MRS allow the viewing of these subtle yet important changes in brain function
Citicoline is used to treat victims of head trauma and neurodegenerative disorders It has been found to be effective in reducing cocaine use and craving and it has no known side effects It has also been shown to reduce marijuana use This is likely due to citicolines ability to reduce insomnia and craving act as a mild antidepressant and improve cognitive function How citicoline reduces drug use may be related to effects on cerebral blood flow andor brain phospholipid metabolism in the reward areas of the brain
This study will determine whether citicoline alters marijuana use patterns reduces craving and affects brain phospholipids and metabolism in marijuana-dependent people The outcome of the study could offer important insights into the pathophysiology and course of marijuana dependence Furthermore this studys outcome could potentially relate to other drug dependence disorders
Citicoline is used to treat victims of head trauma and neurodegenerative disorders It has been found to be effective in reducing cocaine use and craving and it has no known side effects It has also been shown to reduce marijuana use This is likely due to citicolines ability to reduce insomnia and craving act as a mild antidepressant and improve cognitive function How citicoline reduces drug use may be related to effects on cerebral blood flow andor brain phospholipid metabolism in the reward areas of the brain
This study will determine whether citicoline alters marijuana use patterns reduces craving and affects brain phospholipids and metabolism in marijuana-dependent people The outcome of the study could offer important insights into the pathophysiology and course of marijuana dependence Furthermore this studys outcome could potentially relate to other drug dependence disorders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA024007 | NIH | NIDA | httpsreporternihgovquickSearchR01DA024007 |
| R01DA019238 | NIH | None | None |
| DPMC | OTHER | None | None |