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| ID | Type | Description | Link |
|---|---|---|---|
| Y1-DA4006 | Other Grant/Funding Number | NIDA/VA CSP #1030 |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| VA Office of Research and Development | FED |
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The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher than seen in subjects treated with placebo in addition to counseling.
The objective of this 26-28 week study is to demonstrate that the rate of cocaine dependent subjects treated with CPP-109 vigabatrin in addition to counseling, who completely stop use of cocaine in the last 2 weeks of the study's Treatment Phase (Weeks 8 and 9) will be higher than seen in subjects treated with placebo in addition to counseling.
There are 3 Phases to this study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CPP-109 Vigabatrin Tablets | Active Comparator | Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase During treatment, subjects received 3 CPP-109 Vigabatrin 500 mg Tablets, bid, for 9 weeks Subjects were provided with on-site, supervised, standardized, manualized Individual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13) |
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| Placebo | Placebo Comparator | Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during a -2 to -4 week Screening/Baseline Phase During treatment, subjects received Vigabatrin matching placebo tablets, bid, for 9 weeks Subjects were provided with on-site, supervised, standardized, manualized Indivdiual Drug Counseling 1x per week for 9 weeks and the first 4 weeks for the follow-up phase (weeks 10-13) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vigabatrin | Drug | Tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Abstinence | The number of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (Weeks 8 and 9). | Weeks 8-9 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Cocaine Use | Week 3 - 9 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Brady, MD, PhD | Medical University of South Carolina | Principal Investigator |
| Christopher J Stock, PharmD | George E. Wahlen VA Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Matrix Institute on Addictions | Los Angeles | California | 90016 | United States | ||
| Friends Research Institute |
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| ID | Title | Description |
|---|---|---|
| FG000 | CPP-109 Vigabatrin Tablets | Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks. |
| FG001 | Placebo | Participants received Vigabatrin placebo table orally once daily for 7 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Matching Placebo | Drug | Tablets |
|
| Torrance |
| California |
| 90502 |
| United States |
| VA Medical Center | Denver | Colorado | 80220 | United States |
| University of Miami School of Medicine | Miami | Florida | 33136 | United States |
| NeuroPsychiatric Research & Practice Assoc., Ltd. | Oak Brook | Illinois | 60523 | United States |
| Mountain Manor Treatment Center @ Baltimore | Baltimore | Maryland | 21229 | United States |
| Boston University School of Medicine | Boston | Massachusetts | 02118 | United States |
| Pacific Institute for Research and Evaluation | Albuquerque | New Mexico | 87102 | United States |
| Western Psychiatric Inst. and Clinic | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29403 | United States |
| Pillar Clinical Research, LLC | Dallas | Texas | 75243 | United States |
| University of Texas Health Science Center at Houston | Houston | Texas | 77054 | United States |
| George E Wahlen VA Medical Center | Salt Lake City | Utah | 84148 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | CPP-109 Vigabatrin Tablets | Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks. |
| BG001 | Placebo | Participants received Vigabatrin placebo table orally once daily for 7 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 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 | The number of subjects in each treatment group who are cocaine abstinent during the last 2 weeks of the Treatment Phase (Weeks 8 and 9). | Posted | Number | participants | Weeks 8-9 |
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| Secondary | Number of Participants With Cocaine Use | Posted | Number | participants | Week 3 - 9 |
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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 | CPP-109 Vigabatrin Tablets | Participants received Vigabatrin 3.0 gm tablet orally once daily for 7 weeks. | 6 | 103 | 84 | 103 | ||
| EG001 | Placebo | Participants received Vigabatrin placebo table orally once daily for 7 weeks. | 3 | 104 | 89 | 104 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | General disorders | Systematic Assessment |
| ||
| Depression suicidal | Psychiatric disorders | Systematic Assessment |
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| Psychiatric symptom | Psychiatric disorders | Systematic Assessment |
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| Blood pressure increased | Investigations | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Loss of conciousness | Nervous system disorders | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
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| Insomnia | Psychiatric disorders | Systematic Assessment |
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| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | Systematic Assessment |
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| Photopsia | Eye disorders | Systematic Assessment |
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| Blood pressure increased | Investigations | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Hypertension | Vascular disorders | Systematic Assessment |
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| Dysmenorrhoea | Reproductive system and breast disorders | Systematic Assessment |
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| Increased appetite | Metabolism and nutrition disorders | Systematic Assessment |
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| Immune system disorders | Renal and urinary disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David McCann, Ph.D. | National Institute on Drug Abuse | 301-443-2999 | dmccann@nida.nih.gov |
| 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 |
|---|---|
| D020888 | Vigabatrin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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