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| ID | Type | Description | Link |
|---|---|---|---|
| P50DA012756 | U.S. NIH Grant/Contract | View source | |
| 2009-013647-10 | EudraCT Number |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| Society of Alcoholism and other Addictions | UNKNOWN |
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Until positive results were found with oral naltrexone, no medication has been effective against amphetamine dependence. The primary aim of this pilot study is to replicate the findings of the Swedish team that showed oral Naltrexone prevented relapse to amphetamine addiction and to extend their results by randomizing treatment-seeking amphetamine addicted patients to a 6 month course of VIVITROL (naltrexone for extended-release injectable suspension) or VIVITROL placebo. Patients in each group will receive drug counseling. VIVITROL is administered monthly and may be a better test of efficacy than tablets that must be taken daily.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended release VIVITROL injection 380 mg, 24 weeks | Active Comparator | Efficacy of 24 week course of Extended Release VIVITROL 380 mg with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections) |
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| VIVITROL placebo injection, 24 weeks | Placebo Comparator | Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VIVITROL injection and VIVITROL Placebo Injection , 24 weeks | Drug | Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections) |
| Measure | Description | Time Frame |
|---|---|---|
| Number Negative Urines (Proportion Negative Urines) | 24 Weeks | |
| Number Negative Urines (Proportion Negative Urines) Amphetamine | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Amphetamine Craving Scale | The Amphetamine Craving Scale is a visual analogue scale, which is scored by indicating the level of craving on a 100 mm line, where 0 is no craving at all and 100 is the highest level of craving experienced. Scores are derived from measuring their placement on the line, yielding scores from 0 to 100. | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen Pettinati, Ph.D | University of Pennsylvania | Principal Investigator |
| George Woody, M.D. | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SAA National Center of Addiction Medicine, Vogur Hospital | Storhofda 45 | Reykjavík | 112 | Iceland |
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| ID | Title | Description |
|---|---|---|
| FG000 | VIVITROL Injection, 24 Weeks | Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections) |
| FG001 | VIVITROL Placebo Injection, 24 Weeks | Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections) |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | VIVITROL Injection, 24 Weeks | Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections) |
| BG001 | VIVITROL Placebo Injection, 24 Weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Negative Urines (Proportion Negative Urines) | Urine drug screens negative amphetamine | Posted | Number | Urine Drug Screen | 24 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 | VIVITROL Injection, 24 Weeks | Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitilization due to relapse to substance disorder | Psychiatric disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea, diarrhea, discomfort/pain from stomach, heartburn | Gastrointestinal disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Helen Pettinati | University of Pennsylvania | 215-222-3200 | 139 | helenp@mail.med.upenn.edu |
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| ID | Term |
|---|---|
| D019969 | Amphetamine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000624616 | vivitrol |
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| Beck Depression Inventory |
The Beck Depression Inventory is a self-administered questionnaire that assess the severity of depressive symtpoms. It consists of 21 items about how the subject has been feeling in the last week, and each item has a set of at least four possible answer choices, ranging in intensity, yielding scores from 0-3, with a total possible score of 63. Higher scores indicate more severe depressive symptoms. |
| 24 weeks |
| Risk Assessment Battery | The Risk Assessment Battery is a 41 item self-report questionnaire that assess risk behaviors related to HIV infection over the past 6 months. The measure yields a Drug risk score ranging from 0-22 and a Sex risk score ranging from 0-18, with higher scores indicating more risk; these scores are added to yield a Total RAB score ranging from 0-40. This total scores is then divided by 40 to yield a RAB Scale Score from 0-1. | 24 weeks |
| Prior Admissions to Vogur Hospital | Number of prior admissions due to substance dependence. The term "prior admissions" refers to admissions before enrollment, thus Baseline is the appropriate Time Frame. | Baseline |
| Withdrawal by Subject |
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Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Amphetamine Craving Scale | The Amphetamine Craving Scale is a visual analogue scale, which is scored by indicating the level of craving on a 100 mm line, where 0 is no craving at all and 100 is the highest level of craving experienced. Scores are derived from measuring their placement on the line, yielding scores from 0 to 100. | Posted | Mean | Standard Deviation | VAS Score | 24 weeks |
|
|
|
| Secondary | Beck Depression Inventory | The Beck Depression Inventory is a self-administered questionnaire that assess the severity of depressive symtpoms. It consists of 21 items about how the subject has been feeling in the last week, and each item has a set of at least four possible answer choices, ranging in intensity, yielding scores from 0-3, with a total possible score of 63. Higher scores indicate more severe depressive symptoms. | Posted | Mean | Standard Deviation | BDI Score | 24 weeks |
|
|
|
| Secondary | Risk Assessment Battery | The Risk Assessment Battery is a 41 item self-report questionnaire that assess risk behaviors related to HIV infection over the past 6 months. The measure yields a Drug risk score ranging from 0-22 and a Sex risk score ranging from 0-18, with higher scores indicating more risk; these scores are added to yield a Total RAB score ranging from 0-40. This total scores is then divided by 40 to yield a RAB Scale Score from 0-1. | Posted | Mean | Standard Deviation | Total Score | 24 weeks |
|
|
|
| Secondary | Prior Admissions to Vogur Hospital | Number of prior admissions due to substance dependence. The term "prior admissions" refers to admissions before enrollment, thus Baseline is the appropriate Time Frame. | Posted | Mean | Standard Deviation | Number of admissions | Baseline |
|
|
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| Primary | Number Negative Urines (Proportion Negative Urines) Amphetamine | Posted | Number | Urine Drug Screen | 24 weeks |
|
|
|
| 9 |
| 51 |
| 28 |
| 51 |
| EG001 | VIVITROL Placebo Injection, 24 Weeks | Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections) | 7 | 49 | 27 | 49 |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders |
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| Abdominal pain, elevated liver enzymes | Hepatobiliary disorders |
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| Potential suicide attempt | Psychiatric disorders |
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| Skin and subcutaneous tissue disorders | Skin and subcutaneous tissue disorders |
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| Symptoms of depression and/or anxiety | Psychiatric disorders |
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| Dizziness, fatigue, fainting sensation | Nervous system disorders |
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| Elevated ALT level >5 times normal range | Hepatobiliary disorders |
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| Headache | General disorders |
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| Other, feeling unwell, fever, loss of appetite, joint pain, pruritus, sore throat, etc. | General disorders |
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