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| ID | Type | Description | Link |
|---|---|---|---|
| 2P50DA009262-16A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The University of Texas Health Science Center, Houston | OTHER |
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study is to examine the role of brain MRI findings in predicting treatment outcomes among individuals with cocaine dependence.
The Specific Aims of this project are:
Aim 1: To determine whether pretreatment brain activation on fMRI while performing a Go-Nogo task predicts response to pharmacotherapy in cocaine dependent subjects.
Hypothesis related to Aim 1:
Pretreatment fMRI BOLD activation in cocaine dependent subjects during impulsive responding on the Go-Nogo task predicts 8-week outcome from medication known to enhance serotonin function (citalopram). The regression coefficient of TES on pretreatment mean BOLD activation on the Go-Nogo task will be significantly greater for the citalopram group than the placebo group.
Aim 2: To determine whether pretreatment brain activation on fMRI while performing an attentional bias (cocaine Stroop) task predicts response to pharmacotherapy in cocaine dependent subjects.
Hypothesis related to Aim 2:
Pretreatment fMRI BOLD activation in cocaine dependent subjects during cocaine related words on the cocaine Stroop task predicts 8-week outcome from medication known to enhance serotonin function (citalopram). The regression coefficient of TES on pretreatment mean BOLD activation from the cocaine Stroop task will be significantly greater for the citalopram group than the placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medication (Citalopram 20mg) | Experimental | Citalopram (20mg dose) |
|
| Placebo | Placebo Comparator |
| |
| Medication (Citalopram 40mg) | Experimental | Citalopram 40mg dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citalopram | Drug | 20 mg or 40 mg daily for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cocaine Use/Treatment Effectiveness Score (TES) | Number of benzoylecgonine negative urines divided by the total number of urines collected | 8 weeks of treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| fMRI Brain Activation in Right Inferior Frontal Gyrus | Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score. | Baseline |
| fMRI Brain Activation in Right Precentral Gyrus |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frederick G Moeller, M.D. | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
For some consented participants, the imaging scan (MRI) quality was not sufficient to include those participants in the outcome analysis. These participants are captured by the"excluded from analysis by MRI" category. fMRI data was only analyzed from participants who underwent MRI scans at UT Houston which can't be combined with MRI scans at VCU.
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| ID | Title | Description |
|---|---|---|
| FG000 | Medication Citalopram (20mg Dose) | Citalopram (20mg dose) Citalopram: 20 mg daily for 8 weeks |
| FG001 | Placebo | Placebo: Placebo daily for 8 weeks |
| FG002 | Medication Citalopram (40mg Dose) | Citalopram (40mg dose) 40mg daily for 8 weeks |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Medication Citalopram 20mg | Citalopram (20mg dose) Citalopram: 20 mg daily for 8 weeks |
| BG001 | Placebo | Placebo: Placebo daily for 8 weeks |
| 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 | Cocaine Use/Treatment Effectiveness Score (TES) | Number of benzoylecgonine negative urines divided by the total number of urines collected | Posted | Number | percentage of negative urines | 8 weeks of treatment |
|
12 weeks
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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 | Medication (Citalopram 20mg) | Citalopram (20mg dose) Citalopram: 20 mg or 40 mg daily for 8 weeks |
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Results should be viewed with caution due to small sample size. Data was only analyzed from participants who underwent MRI scans at UT Houston as data could not be combined with MRI scans at VCU.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| F. Gerard Moeller, M.D. | VCU | 804-828-4134 | frederick.moeller@vcuhealth.org |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| D019966 | Substance-Related Disorders |
| D007175 | Impulsive Behavior |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Placebo | Drug | Placebo daily for 8 weeks |
|
Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score. |
| Baseline |
| fMRI Brain Activation in Right Orlandic Operculum | Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score. | Baseline |
| BG002 | Medication Citalopram 40mg | Citalopram (40mg dose) 40mg daily for 8 weeks |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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|
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| Other Pre-specified | fMRI Brain Activation in Right Inferior Frontal Gyrus | Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score. | Posted | Number | Percent of significant voxels in cluster | Baseline |
|
|
|
| Other Pre-specified | fMRI Brain Activation in Right Precentral Gyrus | Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score. | Posted | Number | percent of significant voxels in cluster | Baseline |
|
|
|
| Other Pre-specified | fMRI Brain Activation in Right Orlandic Operculum | Brain activation on fMRI while participants undergo a Go/Nogo task. Percent of significant cluster in Statistical Parametric Mapping (SPM) for contrast of Hard Nogo minus Easy Nogo correlation with treatment effectiveness score. | Posted | Number | percent of significant voxels in cluster | Baseline |
|
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| 0 |
| 6 |
| 0 |
| 6 |
| 0 |
| 6 |
| EG001 | Placebo | Placebo: Placebo daily for 8 weeks | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Medication (Citalopram 40mg) | Citalopram 40mg dose Citalopram: 20 mg or 40 mg daily for 8 weeks | 0 | 6 | 0 | 6 | 0 | 6 |
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| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |