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| ID | Type | Description | Link |
|---|---|---|---|
| eudraCT 2005-06-01 |
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The aim of this study is to assess the efficacy of caffeine compared to placebo as a maintenance treatment for cocaine dependence. Caffeine potentiation with biperiden will be also studied.
Ninety patients with snorted/sniffed cocaine dependence will be randomized to receive caffeine (300 - 1200 mg t.i.d.) plus biperidene (8 mg b.i.d.) caffeine (300 - 1200 mg t.i.d.) with placebo or placebo during 10 days in an in-hospital setting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | caffeine + placebo |
|
| 2 | Experimental | caffeine + biperiden |
|
| 3 | Placebo Comparator | Placebo+placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| caffeine | Drug | caffeine from 300 to 1200 mg/d or 15 mg/kg/d, divided in 3 doses per day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| survival | 22 weeks | |
| cocaine use | 22 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miquel Casas, Prof. | Contact | 0034 93 489 42 94 | mcasas@vhebron.net | |
| Xavier Castells, MD | Contact | 0034 93 489 42 94 | xcc@icf.uab.cat |
| Name | Affiliation | Role |
|---|---|---|
| Miquel Casas, Prof. | Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari Vall d'Hebron | Recruiting | Barcelona | Catalonia | 08035 | Spain |
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| ID | Term |
|---|---|
| D019970 | Cocaine-Related Disorders |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D002110 | Caffeine |
| D001712 | Biperiden |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
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| Biperiden | Drug | Biperiden 2-4 mg/d, divided in 2 doses per day. |
|
|
| Placebo | Drug | Placebo |
|
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D001643 | Bridged Bicyclo Compounds |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D053961 | Azabicyclo Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |