Trial · NCT00950352
Citicoline Treatment of Methamphetamine Dependence
NCT00950352, Phase 3, Completed, Perry Renshaw; results first posted 2015-02-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Citicoline Treatment of Methamphetamine Dependence. Trials, record NCT00950352. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00950352
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Citicoline Treatment of Methamphetamine Dependence
- NCT number
- NCT00950352
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 104 participants, actual
- Lead sponsor
- Perry Renshaw
- Conditions
- Methamphetamine Dependence
- Interventions
- Citicoline, Placebo
- First posted
- 2009-07-31
- Last updated
- 2015-02-11
- Results first posted
- 2015-02-11
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Methamphetamine Dependent Subjects Treated With Citicoline vs Placebo | 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. |
| Secondary | Testing if Citicoline Administration Will be Associated With Significant Improvements in Neuropsychological Performance. | Neuropsychological testing will occur at week 0 and week 8/9 | Cognitive measurement tests will be employed. |
| 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. | 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. |
| Secondary | Testing if Improvements in Cognitive Function as Well as Brain Chemical and Structural Parameters Will be Associated With Greater Reductions in Drug Use. | 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. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Methamphetamine Dependent Subjects Treated With Citicoline vs Placebo | 8 weeks, assessed twice weekly starting week1 | total amount consumed in grams | MEAN | |
| SECONDARY | Testing if Citicoline Administration Will be Associated With Significant Improvements in Neuropsychological Performance. | 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. | 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. | Throughout the course of the study |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Methamphetamine Dependent Subjects Treated With Citicoline vs Placebo | Citicoline | 0.3025 | Standard Deviation 0.16498 | total amount consumed in grams | |
| Methamphetamine Dependent Subjects Treated With Citicoline vs Placebo | Placebo | 0.3850 | Standard Deviation 0.34547 | total amount consumed in grams |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Citicoline | 72 | |
| Overall Study | STARTED | Placebo | 32 | |
| Overall Study | COMPLETED | Citicoline | 30 | |
| Overall Study | COMPLETED | Placebo | 21 | |
| Overall Study | NOT COMPLETED | Citicoline | 42 | |
| Overall Study | NOT COMPLETED | Placebo | 11 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gatsrointestinal symptoms | Gastrointestinal disorders | Citicoline | 2 | 72 | 2 |
| other | Gatsrointestinal symptoms | Gastrointestinal disorders | Placebo | 4 | 32 | 4 |
| other | General (Weight loss, Headache, Cold/flu-lie symptoms, fatigue, pulmonary) | General disorders | Citicoline | 6 | 72 | 6 |
| other | General (Weight loss, Headache, Cold/flu-lie symptoms, fatigue, pulmonary) | General disorders | Placebo | 6 | 32 | 6 |
| other | Psychiatric | Psychiatric disorders | Citicoline | 2 | 72 | 2 |
| other | Psychiatric | Psychiatric disorders | Placebo | 4 | 32 | 4 |
| serious | Suicide attempt | Psychiatric disorders | Citicoline | 1 | 72 | 1 |
| serious | Suicide attempt | Psychiatric disorders | Placebo | 0 | 32 | 0 |
| serious | Sepsis | Infections and infestations | Citicoline | 1 | 72 | 1 |
| serious | Sepsis | Infections and infestations | Placebo | 0 | 32 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Citicoline | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Citicoline | 10 | 72 |
| Total, other adverse events | Placebo | 14 | 32 |
| Total, serious adverse events | Citicoline | 2 | 72 |
| Total, serious adverse events | Placebo | 0 | 32 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Citicoline vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00950352
GET https://conductscience.org/api/trials/v1/NCT00950352/registered