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The objective of this study is to evaluate the safety and efficacy of Nepicastat in improving the number of subjects that achieve abstinence from cocaine and reducing cocaine use in subjects with cocaine dependence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nepicastat | Active Comparator | Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks |
|
| Placebo | Placebo Comparator | Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nepicastat | Drug | 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence (Weeks 10 - 11) | Number of subjects that abstained from cocaine from weeks 10 through 11 | Weeks 10 - 11 |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in Use (Weeks 1 - 11) | Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11 | Baseline through week 11 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Matrix Institute on Addictions | Los Angeles | California | 90016 | United States | ||
| VA San Diego Healthcare System |
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| ID | Title | Description |
|---|---|---|
| FG000 | Nepicastat | Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks. |
| FG001 | Placebo | Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks. Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nepicastat | Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 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, 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 | Abstinence (Weeks 10 - 11) | Number of subjects that abstained from cocaine from weeks 10 through 11 | Posted | Count of Participants | Participants | Weeks 10 - 11 |
|
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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 | Nepicastat | Nepicastat 120mg and 100mg riboflavin (once per day) for 11 weeks Nepicastat: 120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization for Chest Pain | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Liza Zeinert | National Institute on Drug Abuse | 301-443-1138 | liza.zeinert@nih.gov |
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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 |
|---|---|
| C109487 | nepicastat |
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| Placebo | Drug |
|
| San Diego |
| California |
| 92161 |
| United States |
| VA Medical Center - Denver, CO | Denver | Colorado | 80220 | United States |
| Mountain Manor Treatment Center at Baltimore | Baltimore | Maryland | 21229 | United States |
| Pacific Institute for Research and Evaluation | Albuquerque | New Mexico | 87102 | United States |
| Columbia University Medical Center | New York | New York | 10019 | United States |
| Cincinnati Addiction Research Center | Cincinnati | Ohio | 45220 | United States |
| University of Pennsylvania - Treatment Research Center | Philadelphia | Pennsylvania | 19104 | United States |
| Michael E. DeBakey VA Medical Center | Houston | Texas | 77030 | United States |
| George E. Wahlen VA Medical Center | Salt Lake City | Utah | 84148 | United States |
Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks. Placebo |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Reduction in Use (Weeks 1 - 11) | Proportion of Subjects with a 50% or More Reduction in Cocaine Use from Baseline through week 11 | Posted | Number | participants | Baseline through week 11 |
|
|
|
| 8 |
| 90 |
| 80 |
| 90 |
| EG001 | Placebo | Placebo capsule containing 100mg riboflavin (once per day) for 11 weeks. Placebo | 2 | 89 | 67 | 89 |
| Hospitalization for Concussion | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hospitalization for acute pancreatitis | Gastrointestinal disorders | Systematic Assessment |
|
| Hospitalization for Congestive Heart Failure | Cardiac disorders | Systematic Assessment |
|
| Atrial Flutter | Cardiac disorders | Systematic Assessment |
|
| Hospitalization for depression and suicidality | Psychiatric disorders | Systematic Assessment |
|
| Hospitalization for angioedema secondary to lisinopril | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hospitalization for head wounds and cracked ribs | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Hospitalization for the flu | Infections and infestations | Systematic Assessment |
|
| Hospitalization for stab wound | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | Nervous system disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hypertension | Vascular disorders | Systematic Assessment |
|
| Dizziness | Nervous system disorders | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Abdominal Discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Ear pain | Ear and labyrinth disorders | Systematic Assessment |
|
| Blurred Vision | Eye disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
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