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| Name | Class |
|---|---|
| German Federal Ministry of Education and Research | OTHER_GOV |
| Merck Sharp & Dohme LLC | INDUSTRY |
| Dupont Applied Biosciences | INDUSTRY |
The primary objective is to directly compare the efficacy of acamprosate, naltrexone and placebo for relapse prevention in alcoholics.
The primary objective is to directly compare the efficacy of acamprosate, naltrexone and placebo for relapse prevention in alcoholics. The secondary objective is to establish an association between patients' motivational type and drug effects. The aim is to improve alcoholism treatment by identifying characteristics for response to specific pharmacological relapse prevention. Such items could allow for an individually adapted pharmacotherapy of alcoholism. Specifically, we will study the possible dependence of the efficacy of naltrexone and/or acamprosate on different motivational types (reward versus relief craving) and genetic profiles referring to glutamatergic and opioidergic candidate genes. Lastly, the longterm costs and cost-effectiveness of the different treatment strategies for alcoholics chosen in our study are established.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Acamprosate |
|
| 2 | Active Comparator | Naltrexone |
|
| 3 | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acamprosate or Naltrexone | Drug | mg&d 90 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| time to relapse to heavy drinking (consumption of more than 48 gram alcohol/day for females and more than 60 gram alcohol/day for males) | 06/2008 |
| Measure | Description | Time Frame |
|---|---|---|
| percentage of days without heavy drinking (consumption of more than 48 gram alcohol/day for females and more than 60 gram alcohol/day for males) | 06/2008 | |
| time to first alcohol consumption | 06/2008 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karl F. Mann, MD | Central Institute of Mental Health, J5, 68159 Mannheim, Germany | Principal Investigator |
| Michael N. Smolka, MD | Central Insitute of Mental Health, J5, 68159 Mannheim, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry, University of Freiburg | Freiburg im Breisgau | Baden-Wurttemberg | 79104 | Germany | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25593047 | Derived | Reinhard I, Lemenager T, Fauth-Buhler M, Hermann D, Hoffmann S, Heinz A, Kiefer F, Smolka MN, Wellek S, Mann K, Vollstadt-Klein S. A comparison of region-of-interest measures for extracting whole brain data using survival analysis in alcoholism as an example. J Neurosci Methods. 2015 Mar 15;242:58-64. doi: 10.1016/j.jneumeth.2015.01.001. Epub 2015 Jan 12. | |
| 25421512 |
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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 |
| D009271 | Naltrexone |
| ID | Term |
|---|---|
| D013654 | Taurine |
| D017738 | Alkanesulfonic Acids |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
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| percentage of days of complete abstinence from alcohol | 06/2008 |
| Department of Psychiatry, University of Heidelberg |
| Heidelberg |
| Baden-Wurttemberg |
| 69115 |
| Germany |
| Department of Addictive Behavior und Addiction Medicine, Central Institute of Mental Health | Mannheim | Baden-Wurttemberg | 68159 | Germany |
| Department of Psychiatry, University of Tübingen | Tübingen | Baden-Wurttemberg | 72076 | Germany |
| Department of Psychiatry, University of Regensburg | Regensburg | Bavaria | 93053 | Germany |
| Mann K, Vollstadt-Klein S, Reinhard I, Lemenager T, Fauth-Buhler M, Hermann D, Hoffmann S, Zimmermann US, Kiefer F, Heinz A, Smolka MN. Predicting naltrexone response in alcohol-dependent patients: the contribution of functional magnetic resonance imaging. Alcohol Clin Exp Res. 2014 Nov;38(11):2754-62. doi: 10.1111/acer.12546. |
| 25269022 | Derived | Lemenager T, Hill H, Reinhard I, Hoffmann S, Zimmermann US, Hermann D, Smolka MN, Kiefer F, Vollstadt-Klein S, Heinz A, Mann K. Association between alcohol-cue modulated startle reactions and drinking behaviour in alcohol dependent patients - results of the PREDICT study. Int J Psychophysiol. 2014 Dec;94(3):263-71. doi: 10.1016/j.ijpsycho.2014.09.009. Epub 2014 Sep 28. |
| 23231446 | Derived | Mann K, Lemenager T, Hoffmann S, Reinhard I, Hermann D, Batra A, Berner M, Wodarz N, Heinz A, Smolka MN, Zimmermann US, Wellek S, Kiefer F, Anton RF; PREDICT Study Team. Results of a double-blind, placebo-controlled pharmacotherapy trial in alcoholism conducted in Germany and comparison with the US COMBINE study. Addict Biol. 2013 Nov;18(6):937-46. doi: 10.1111/adb.12012. Epub 2012 Dec 12. |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D009270 | Naloxone |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |