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| ID | Type | Description | Link |
|---|---|---|---|
| K23AA000222 | U.S. NIH Grant/Contract | View source |
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Not enough sugjects enrolled before funding ran out
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| Name | Class |
|---|---|
| National Institute on Alcohol Abuse and Alcoholism (NIAAA) | NIH |
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The purpose of this study is to test how tolerable and effective acamprosate is when used to prevent alcohol relapse in criminal justice supervisees (those on probation, parole, or in drug court).
Acamprosate has been an available treatment for alcohol dependence outside the United States and has recently been approved by the U.S. Food and Drug Administration as an effective therapy for alcohol dependence. In the past ten years, drug court programs have been implemented as one possible solution to reduce the burden placed on state and federal correctional systems. These programs are generally focused on non-violent drug dependent offenders and are offered as an alternative to incarceration. However, the use of acamprosate has never been examined for alcohol relapse prevention among a drug court population, or among those on probation or parole.
Comparison: Alcohol-dependent criminal justice supervisees who receive acamprosate, compared to participants who do not receive acamprosate.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acamprosate | Experimental | Subjects randomized to receive acamprosate |
|
| No medication | No Intervention | No medication intervention (subjects do not receive acamprosate), but do receive Building Social Networks counseling |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acamprosate | Drug | Subjects randomized to receive acamprosate 333 mg tablets to be taken 3 times daily to prevent relapse to alcohol dependence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Drinking and Other Drug Use | Number of participants using alcohol and other drugs during 12 weeks | 12 weeks |
| Level of Acceptance | Number of participants taking study medication during 12 weeks | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Retention in Drug Court | Number of participants remaining in drug treatment court program during 12 weeks | 12 weeks |
| Recidivism Rates | Number of participants returning to jail during 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael F. Weaver, MD | Virginia Commonwealth University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University Medical Center | Richmond | Virginia | 23219 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Acamprosate | Criminal justice supervisees given acamprosate 333 mg, 2 tablets orally 3 times daily for alcohol dependence for a 12-week period |
| FG001 | Control | No specific intervention, received standard Drug Court counseling, monitored for outcomes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Acamprosate | Criminal justice supervisees given acamprosate for alcohol dependence |
| BG001 | Control | No specific intervention, monitored for outcomes |
| 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 | Drinking and Other Drug Use | Number of participants using alcohol and other drugs during 12 weeks | Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study. No data were collected for the Control Arm because funding ran out for the study. | Posted | Number | participants | 12 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 | Acamprosate | Criminal justice supervisees given acamprosate for alcohol dependence |
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Small numbers of subjects, significant number withdrew or were lost to follow-up
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Weaver, MD | Virginia Commonwealth University | 804-828-1283 | mweaver@mcvh-vcu.edu |
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| ID | Term |
|---|---|
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077443 | Acamprosate |
| ID | Term |
|---|---|
| D013654 | Taurine |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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| 12 weeks |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Primary | Level of Acceptance | Number of participants taking study medication during 12 weeks | Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study. No data were collected for the Control Arm because funding ran out for the study. | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Retention in Drug Court | Number of participants remaining in drug treatment court program during 12 weeks | Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study. No data were collected for the Control Arm because funding ran out for the study. | Posted | Number | participants | 12 weeks |
|
|
|
| Secondary | Recidivism Rates | Number of participants returning to jail during 12 weeks | Only 13 Acamprosate participants were analyzed because one participant was lost to follow-up after being given an initial supply of medication for the study. No data were collected for the Control Arm because funding ran out for the study. | Posted | Number | participants | 12 weeks |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Control | No specific intervention, monitored for outcomes | 0 | 12 | 0 | 12 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |