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| Name | Class |
|---|---|
| University of Wisconsin, Milwaukee | OTHER |
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This is a study of a medication, acamprosate, which is an FDA approved medication for alcohol problems. We will be examining whether acamprosate compared to a sugar pill (placebo) is more effective for helping with drinking in a Family Medicine clinic.
Acamprosate has been shown to reduce drinking days in alcohol dependent patients and promote abstinence, with few reported side effects. A limitation of these studies, however, has been their lack of generalizability due to restrictive inclusion and exclusion criteria. Furthermore, most of the previous studies of acamprosate have been conducted in Europe, in a different treatment setting from the typical American Family Medicine center, where alcohol dependent patients are most likely to be first identified in the U.S.
The present study is designed to determine the efficacy of acamprosatefor alcohol dependence in a Family Medicine setting using minimal psychotherapeutic interventions-as would also likely occur in a primary care setting. The study will be a 12-week, double-blind, placebo-controlled, randomized trial comparing 666 mg acamprosate t.i.d. to placebo in patients at the UNC Family Medicine Center with alcohol dependence. Subjects will be seen by Family Medicine physicians and receive brief motivational interventions. Primary efficacy will be determined by measuring % days abstinent and secondary outcomes include rates of complete abstinence, % heavy drinking days, CGI and GGT in the acamprosate group compared to the placebo group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1- Acamprosate | Active Comparator | The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit. |
|
| 2 - Sugar Pill - Placebo | Placebo Comparator | The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acamprosate (Campral) | Drug | The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit. |
| Measure | Description | Time Frame |
|---|---|---|
| % Dropout | Percentage of participants who dropped out of study by drug condition | 12 weeks |
| Percent Days Abstinent | %Days without any alcohol consumption over the treatment period | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Retention | Number of individuals retained in the trial by acamprosate vs placebo group | 12 weeks |
| Percent With Complete Abstinence | % of subjects with no drinking during the 12 week treatment trial |
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INCLUSION CRITERIA:
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| JC Garbutt, MD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNC Family Medicine Center | Chapel Hill | North Carolina | 27599 | United States | ||
| Center for Addiction and Behavioral Health Research University of Wisconsin-Milwaukee |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 7662044 | Background | Paille FM, Guelfi JD, Perkins AC, Royer RJ, Steru L, Parot P. Double-blind randomized multicentre trial of acamprosate in maintaining abstinence from alcohol. Alcohol Alcohol. 1995 Mar;30(2):239-47. | |
| 9328500 | Background | Pelc I, Verbanck P, Le Bon O, Gavrilovic M, Lion K, Lehert P. Efficacy and safety of acamprosate in the treatment of detoxified alcohol-dependent patients. A 90-day placebo-controlled dose-finding study. Br J Psychiatry. 1997 Jul;171:73-7. doi: 10.1192/bjp.171.1.73. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1- Acamprosate | The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit. |
| FG001 | 2 - Sugar Pill - Placebo | The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 1- Acamprosate | The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit. |
| BG001 |
| 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 | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | Retention | Number of individuals retained in the trial by acamprosate vs placebo group | 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 | 1- Acamprosate | The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. J.C. Garbutt | University of North Carolina at Chapel Hill | 919-966-4652 | jc_garbutt@med.unc.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 |
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D013654 | Taurine |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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|
|
| 12 weeks |
| % Heavy Drinking Days During Trial | % of Heavy drinking days (5 or more drinks/d for a man or 4 or more drinks/d for a woman) over the 12 weeks of the trial. | 12 weeks |
| Clinical Global Impression Scale | Range of overall severity of illness: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill | 12 weeks |
| % Compliant With Medication | % of individuals with evidence for 80% compliance with medication based on returned blister packs and weekly diaries. | 12 weeks |
| Milwaukee |
| Wisconsin |
| 53211 |
| United States |
| 8694680 | Background | Sass H, Soyka M, Mann K, Zieglgansberger W. Relapse prevention by acamprosate. Results from a placebo-controlled study on alcohol dependence. Arch Gen Psychiatry. 1996 Aug;53(8):673-80. doi: 10.1001/archpsyc.1996.01830080023006. |
| 23134193 | Derived | Berger L, Fisher M, Brondino M, Bohn M, Gwyther R, Longo L, Beier N, Ford A, Greco J, Garbutt JC. Efficacy of acamprosate for alcohol dependence in a family medicine setting in the United States: a randomized, double-blind, placebo-controlled study. Alcohol Clin Exp Res. 2013 Apr;37(4):668-74. doi: 10.1111/acer.12010. Epub 2012 Nov 7. |
| wanted more care |
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| incarcerated |
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| 2 - Sugar Pill - Placebo |
The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Primary | % Dropout | Percentage of participants who dropped out of study by drug condition | Posted | Number | percentage of participants | 12 weeks |
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| Primary | Percent Days Abstinent | %Days without any alcohol consumption over the treatment period | Posted | Mean | Standard Deviation | percentage of days | 12 weeks |
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| Secondary | Percent With Complete Abstinence | % of subjects with no drinking during the 12 week treatment trial | Posted | Number | percentage of participants | 12 weeks |
|
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| Secondary | % Heavy Drinking Days During Trial | % of Heavy drinking days (5 or more drinks/d for a man or 4 or more drinks/d for a woman) over the 12 weeks of the trial. | Posted | Mean | Standard Deviation | percentage of heavy drinking days | 12 weeks |
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| Secondary | Clinical Global Impression Scale | Range of overall severity of illness: 1, normal, not at all ill; 2, borderline ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill | Posted | Mean | Standard Deviation | units on a scale | 12 weeks |
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| Secondary | % Compliant With Medication | % of individuals with evidence for 80% compliance with medication based on returned blister packs and weekly diaries. | Posted | Number | percentage of participants | 12 weeks |
|
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| 0 |
| 51 |
| 17 |
| 51 |
| EG001 | 2 - Sugar Pill - Placebo | The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit. | 0 | 49 | 12 | 49 |
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| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D000438 | Alcohols |