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| ID | Type | Description | Link |
|---|---|---|---|
| 2P50DA009262-16A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This is a phase 2 clinical trial of citalopram pharmacotherapy for treatment of cocaine dependence. Using a double-blind, randomized controlled design, eligible cocaine dependent patients will be assigned equally to one of three medication conditions: placebo or the Selective serotonin re-uptake inhibitor (SSRI) agent, citalopram at either 20 mg per day or 40 mg per day. It is hypothesized that citalopram will reduce cocaine use and increase periods of sustained abstinence substantially more than placebo. Performance on a set of behavioral tasks of impulsivity will be analyzed as potential predictors of treatment response.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Citalopram low dose | Active Comparator | Citalopram 20 mg |
|
| Citalopram high dose | Active Comparator | Citalopram 40 mg |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Citalopram | Drug | 20 mg once per day for 9 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test | Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use. | 9 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Cocaine-positive Urines Per Week | Mean proportion of cocaine-positive urines per week, averaged across 9 weeks, is reported. Urine was collected three times each week over 9 weeks. Missing data is imputed as cocaine use. | 9 weeks |
| Number of Participants With Cocaine-negative Urines Collected During Treatment Period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joy M Schmitz, Ph.D. | University of Texas at Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UT-Houston Behavioral and Biomedical Sciences Building | Houston | Texas | 77054 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39853194 | Derived | de Dios C, Suchting R, Green CE, Webber HE, Moeller FG, Lane SD, Schmitz J. The role of Iowa gambling task performance in response to citalopram treatment for cocaine use disorder. Am J Drug Alcohol Abuse. 2025 Jan 2;51(1):73-84. doi: 10.1080/00952990.2024.2420773. Epub 2025 Jan 24. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Citalopram Low Dose | Citalopram 20 mg Citalopram: 20 mg once per day for 9 weeks |
| FG001 | Citalopram High Dose | Citalopram 40 mg Citalopram: 40 mg per day for 9 weeks |
| FG002 | Placebo | Placebo Placebo: 0 mg per day for 9 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Citalopram Low Dose | Citalopram 20 mg Citalopram: 20 mg once per day for 9 weeks |
| BG001 | Citalopram High Dose | Citalopram 40 mg Citalopram: 40 mg per day for 9 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants Who Are Cocaine Abstinent During the Last 2 Weeks of Treatment (Weeks 8-9), as Assessed by Urine Test | Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use. | Posted | Count of Participants | Participants | 9 weeks |
|
9 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 | Citalopram Low Dose | Citalopram 20 mg Citalopram: 20 mg once per day for 9 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for Suicidal Ideation | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Elevated Blood Pressure | Cardiac disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joy M. Schmitz, PhD, Professor and Director of Center For Neurobehavioral Research On Addictions | The University of Texas Health Science Center at Houston | Joy.M.Schmitz@uth.tmc.edu |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D015283 | Citalopram |
| ID | Term |
|---|---|
| D011437 | Propylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D001572 |
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| Citalopram |
| Drug |
40 mg per day for 9 weeks |
|
| Placebo | Drug | 0 mg per day for 9 weeks |
|
Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use. |
| 9 weeks |
| Retention as Assessed by Number of Participants Remaining in Treatment | 9 weeks |
| BG002 | Placebo | Placebo Placebo: 0 mg per day for 9 weeks |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Number of Years of Education | Mean | Standard Deviation | years |
|
| Number of Days of Cocaine Use in Past 30 Days | Mean | Standard Deviation | days |
|
| Placebo |
Placebo Placebo: 0 mg per day for 9 weeks |
|
|
| Secondary | Proportion of Cocaine-positive Urines Per Week | Mean proportion of cocaine-positive urines per week, averaged across 9 weeks, is reported. Urine was collected three times each week over 9 weeks. Missing data is imputed as cocaine use. | Posted | Mean | Standard Deviation | proportion of cocaine urines per week | 9 weeks |
|
|
|
| Secondary | Number of Participants With Cocaine-negative Urines Collected During Treatment Period | Urine samples were tested for benzoylecgonine, which is a metabolite of cocaine that is excreted in the urine. The presence of benzoylecgonine in the urine indicates cocaine use. | Posted | Count of Participants | Participants | 9 weeks |
|
|
|
| Secondary | Retention as Assessed by Number of Participants Remaining in Treatment | Posted | Count of Participants | Participants | 9 weeks |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 9 |
| 21 |
| EG001 | Citalopram High Dose | Citalopram 40 mg Citalopram: 40 mg per day for 9 weeks | 0 | 44 | 0 | 44 | 20 | 44 |
| EG002 | Placebo | Placebo Placebo: 0 mg per day for 9 weeks | 0 | 43 | 1 | 43 | 10 | 43 |
| Abnormal electrocardiogram (EKG) | Cardiac disorders | Systematic Assessment |
|
| Drowsiness | General disorders | Systematic Assessment |
|
| Not Sleeping Well | General disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Nervousness | General disorders | Systematic Assessment |
|
| Blurry Vision | Eye disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Increased Urination | Renal and urinary disorders | Systematic Assessment |
|
| Change in Sexual Function | General disorders | Systematic Assessment |
|
| Sweating | General disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
|
| Difficulty Walking | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Loss of Appetite | General disorders | Systematic Assessment |
|
| Confusion | General disorders | Systematic Assessment |
|
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| Benzofurans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |