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| ID | Type | Description | Link |
|---|---|---|---|
| CDP-1212 |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citicoline | Experimental | In a double-blind randomization design, subjects with methamphetamine dependence will be treated with citicoline or placebo for 8-9 weeks. |
|
| Placebo | Placebo Comparator | In a double-blind randomization design, subjects with methamphetamine dependence will be treated with citicoline or placebo for 8-9 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citicoline | Drug | Subjects will be given 1g citicoline twice daily for a total of 8-9 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Methamphetamine Dependent Subjects Treated With Citicoline vs Placebo | Total Amount of Methamphetamine consumed by the participants after 8-9 weeks of treatment. Methamphetamine was assessed twice weekly. | 8 weeks, assessed twice weekly starting week1 |
| Measure | Description | Time Frame |
|---|---|---|
| Testing if Citicoline Administration Will be Associated With Significant Improvements in Neuropsychological Performance. | Cognitive measurement tests will be employed. | Neuropsychological testing will occur at week 0 and week 8/9 |
| Testing if Neuroimaging Measures Will Show Significant Improvements in Brain Chemical and Structural Parameters After 8-9 Weeks of Citicoline Treatment in Methamphetamine Dependent Subjects. |
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Methamphetamine Dependent Subject Eligibility:
Inclusion Criteria:
Exclusion Criteria:
Healthy Control Subject Eligibility:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Perry F Renshaw, MD, PhD, MBA | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Brain Institute of the University of Utah | Salt Lake City | Utah | 84108 | United States |
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| Label | URL |
|---|---|
| The Brain Institute | View source |
| NIDA | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Methamphetamine Dependent Subjects Treated With Citicoline vs Placebo | Total Amount of Methamphetamine consumed by the participants after 8-9 weeks of treatment. Methamphetamine was assessed twice weekly. | Posted | Mean | Standard Deviation | total amount consumed in grams | 8 weeks, assessed twice weekly starting week1 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Citicoline |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt | Psychiatric disorders | A 36 year old male study participant had a suicide attempt during the eight week of the study. He ingested five Atenolol tablets (100g). Serious adverse event was unexpected and not related to the study medication (citicholine or placebo). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gatsrointestinal symptoms | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Perry Renshaw, MD, PhD, MBA | The Brain Institute of the University of Utah | 801-587-1216 | perry.renshaw@hsc.utah.edu |
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| ID | Term |
|---|---|
| D003566 | Cytidine Diphosphate Choline |
| ID | Term |
|---|---|
| D002794 | Choline |
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
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| Placebo | Drug | 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. |
|
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. |
| Neuroimaging will occur at week 0 and week 8/9 |
| Testing if Improvements in Cognitive Function as Well as Brain Chemical and Structural Parameters Will be Associated With Greater Reductions in Drug Use. | 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. | Throughout the course of the study |
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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Testing if Citicoline Administration Will be Associated With Significant Improvements in Neuropsychological Performance. | Cognitive measurement tests will be employed. | Not Posted | Neuropsychological testing will occur at week 0 and week 8/9 |
| Secondary | Testing if Neuroimaging Measures Will Show Significant Improvements in Brain Chemical and Structural Parameters After 8-9 Weeks of Citicoline Treatment in Methamphetamine Dependent Subjects. | 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. | Not Posted | Neuroimaging will occur at week 0 and week 8/9 |
| Secondary | Testing if Improvements in Cognitive Function as Well as Brain Chemical and Structural Parameters Will be Associated With Greater Reductions in Drug Use. | 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. | Not Posted | Throughout the course of the study |
| 2 |
| 72 |
| 10 |
| 72 |
| EG001 | Placebo | 0 | 32 | 14 | 32 |
|
| Sepsis | Infections and infestations | Subject was hospitalized for sepsis due to an untreated UTI. The serious adverse event was unexpected and not related to the study medication (citicholine or placebo) |
|
| General (Weight loss, Headache, Cold/flu-lie symptoms, fatigue, pulmonary) | General disorders | Symptoms were assessed as "General" irrespective of the actual event |
|
| Psychiatric | Psychiatric disorders |
|
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| D009930 |
| Organic Chemicals |
| D009861 | Onium Compounds |
| D003565 | Cytidine Diphosphate |
| D003597 | Cytosine Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |