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| Name | Class |
|---|---|
| Forest Laboratories | INDUSTRY |
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This clinical trial will compare 10 week treatment with acamprosate (2 gr/day) versus placebo, combined with weekly abstinence oriented individual counseling, in methamphetamine dependent patients, 72 subjects will be enrolled, with an interim analysis scheduled after 36 enrolled. Primary outcome is methamphetamine absitience over the 10 week treatment period, and the last 2 weeks of treatment. Abstinence is defined on a weekly basis as no urine positive of methamphetamine (or amphetamine) and self-report of not use for the 7 day period. Secondary measures include treatment retention, drug craving, mood, and safety.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acamprosate | Active Comparator |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acamprosate | Drug | 2 gr/day (333 mg, TID) |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Methamphetamine Abstinence | 7 day |
| Measure | Description | Time Frame |
|---|---|---|
| Craving | 7 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Malcolm Reid, PhD | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA New York Harbor Healthcare System, MHAD clinic | New York | New York | 10010 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acamprosate | Acamprosate: 2 gr/day (333 mg, TID) |
| FG001 | Placebo | placebo: matching placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acamprosate | Acamprosate: 2 gr/day (333 mg, TID) |
| BG001 | Placebo | placebo: matching placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | PI passed away, and there is no access to data. Although the total number of subjects enrolled is known, information regarding baseline characteristics is unavailable. |
| 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 | Methamphetamine Abstinence | PI passed away, data is unavailable. | Posted | 7 day |
|
|
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PI passed away, and there is no access to data. Information regarding adverse and serious adverse events is unavailable.
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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 | Acamprosate | Acamprosate: 2 gr/day (333 mg, TID) |
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Sadly, the PI of this study passed away on 4/20/2010. Data was not analyzed and is unavailable.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| The Office of Clinical Trials | NYU Langone Medical Center | 212.263.4210 | clinicaltrials@nyumc.org |
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| ID | Term |
|---|---|
| D000077443 | Acamprosate |
| ID | Term |
|---|---|
| D013654 | Taurine |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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| placebo | Drug | matching placebo |
|
| BG002 |
| Total |
Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | PI passed away, and there is no access to data. Although the total number of subjects enrolled is known, information regarding baseline characteristics is unavailable. | Count of Participants | Participants |
|
| Secondary | Craving | PI passed away, data is unavailable | Posted | 7 day |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Placebo | placebo: matching placebo | 0 | 0 | 0 | 0 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |