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The purpose of this study is to assess the efficacy and safety of topiramate as compared to placebo in reducing methamphetamine use in subjects with methamphetamine dependence.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Topiramate | Active Comparator | Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks. |
|
| Placebo Oral Tablet | Placebo Comparator | After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Topiramate | Drug |
|
| |
| Placebo Oral Tablet |
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence (Weeks 6 - 12) | The number of participants who abstained from methamphetamine from weeks 6 through 12 | weeks 6 through 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Abstinence (Weeks 1 - 12) | Number of participants who abstained from methamphetamine from weeks 1 through 12 | Weeks 1 through 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bankole Johnson | VA Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Matrix Institute on Addictions | Costa Mesa | California | 92627 | United States | ||
| South Bay Treatment Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22221594 | Background | Elkashef A, Kahn R, Yu E, Iturriaga E, Li SH, Anderson A, Chiang N, Ait-Daoud N, Weiss D, McSherry F, Serpi T, Rawson R, Hrymoc M, Weis D, McCann M, Pham T, Stock C, Dickinson R, Campbell J, Gorodetzky C, Haning W, Carlton B, Mawhinney J, Li MD, Johnson BA. Topiramate for the treatment of methamphetamine addiction: a multi-center placebo-controlled trial. Addiction. 2012 Jul;107(7):1297-306. doi: 10.1111/j.1360-0443.2011.03771.x. Epub 2012 Feb 28. | |
| 25495887 |
| Label | URL |
|---|---|
| Link to abstract | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Topiramate | Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks. Topiramate |
| FG001 | Placebo Oral Tablet | After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks. Placebo Oral Tablet |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Topiramate | Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks. Topiramate |
| BG001 | Placebo Oral Tablet | After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks. Placebo Oral Tablet |
| 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 6 - 12) | The number of participants who abstained from methamphetamine from weeks 6 through 12 | Posted | Count of Participants | Participants | weeks 6 through 12 |
|
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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 | Topiramate | Subjects will receive topiramate (in tablet form) up to 200 mg/day for 13 weeks. Topiramate |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Superficial Cutting | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA (8.0) | 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 |
|---|---|
| D000077236 | Topiramate |
| ID | Term |
|---|---|
| D005632 | Fructose |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 |
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| Drug |
|
| San Diego |
| California |
| 92105 |
| United States |
| Torrance Site | Torrance | California | 90502 | United States |
| John A. Burns School of Medicine | Honolulu | Hawaii | 96813 | United States |
| Powell Chemical Dependency Center | Des Moines | Iowa | 50316 | United States |
| University of Missouri - Kansas City | Kansas City | Missouri | 64108 | United States |
| Salt Lake City VA Medical Center | Salt Lake City | Utah | 84148 | United States |
| UVA CARE | Charlottesville | Virginia | 22911 | United States |
| Derived |
| Li MD, Wang J, Niu T, Ma JZ, Seneviratne C, Ait-Daoud N, Saadvandi J, Morris R, Weiss D, Campbell J, Haning W, Mawhinney DJ, Weis D, McCann M, Stock C, Kahn R, Iturriaga E, Yu E, Elkashef A, Johnson BA. Transcriptome profiling and pathway analysis of genes expressed differentially in participants with or without a positive response to topiramate treatment for methamphetamine addiction. BMC Med Genomics. 2014 Dec 12;7:65. doi: 10.1186/s12920-014-0065-x. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
|
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| Secondary | Abstinence (Weeks 1 - 12) | Number of participants who abstained from methamphetamine from weeks 1 through 12 | Posted | Count of Participants | Participants | Weeks 1 through 12 |
|
|
|
| 3 |
| 69 |
| 63 |
| 69 |
| EG001 | Placebo Oral Tablet | After randomization subjects will receive topiramate matched placebo (in tablet form), up to 200 mg/day for 13 weeks. Placebo Oral Tablet | 8 | 71 | 64 | 71 |
| Anemia | Blood and lymphatic system disorders | MedDRA (8.0) | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
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| Infected Boil | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
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| Malignant hypertention (with angina) | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
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| Visual Disturbance | Eye disorders | MedDRA (8.0) | Systematic Assessment |
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| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
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| Assault | Social circumstances | MedDRA (8.0) | Systematic Assessment |
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| Pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (8.0) | Systematic Assessment |
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| Abnormal ECG | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
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| Disorientation | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
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| Fatigue | General disorders | MedDRA (8.0) | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
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| Diarrhea | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
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| Carbohydrates |
| D007661 | Ketoses |
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| Week 12 |
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