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Sponsored by: |
Hospital University Vall d'Hebron |
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Information provided by: | Hospital University Vall d'Hebron |
ClinicalTrials.gov Identifier: | NCT00495183 |
The aim of this study is to assess the efficacy of caffeine compared to placebo as a maintence 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 inhospital setting.
Condition | Intervention | Phase |
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Cocaine Dependence |
Drug: caffeine Drug: Biperiden Drug: Placebo |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Efficacy of Caffeine, With and Without Biperiden, as a Maintenance Treatment for Cocaine Dependence |
Estimated Enrollment: | 108 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | July 2010 |
Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
caffeine + placebo
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Drug: caffeine
caffeine from 300 to 1200 mg/d or 15 mg/kg/d, divided in 3 doses per day.
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2: Experimental
caffeine + biperiden
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Drug: caffeine
caffeine from 300 to 1200 mg/d or 15 mg/kg/d, divided in 3 doses per day.
Drug: Biperiden
Biperiden 2-4 mg/d, divided in 2 doses per day.
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3: Placebo Comparator
Placebo+placebo
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Drug: Placebo
Placebo
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Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Miquel Casas, Prof. | 0034 93 489 42 94 | mcasas@vhebron.net |
Contact: Xavier Castells, MD | 0034 93 489 42 94 | xcc@icf.uab.cat |
Spain, Catalonia | |
Hospital Universitari Vall d'Hebron | |
Barcelona, Catalonia, Spain, 08035 |
Principal Investigator: | Miquel Casas, Prof. | Hospital Universitari Vall d'Hebron Barcelona, Catalonia, Spain |
Responsible Party: | Servei de Psiquiatria. Hospital Universitari Vall d'Hebron ( Miguel Casas Brugué ) |
Study ID Numbers: | CAF-MT, eudraCT 2005-06-01 |
Study First Received: | June 29, 2007 |
Last Updated: | June 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00495183 |
Health Authority: | Spain: Spanish Agency of Medicines |
cocaine dependence cocaine use CNS stimulants |
caffeine biperiden placebo |
Caffeine citrate Cocaine-Related Disorders Dopamine Mental Disorders Citric Acid |
Substance-Related Disorders Disorders of Environmental Origin Caffeine Biperiden Cocaine |
Dopamine Uptake Inhibitors Parasympatholytics Neurotransmitter Agents Neurotransmitter Uptake Inhibitors Molecular Mechanisms of Pharmacological Action Cholinergic Antagonists Anti-Dyskinesia Agents Physiological Effects of Drugs Antiparkinson Agents Anesthetics Cholinergic Agents Sensory System Agents Therapeutic Uses |
Vasoconstrictor Agents Central Nervous System Depressants Enzyme Inhibitors Central Nervous System Stimulants Cardiovascular Agents Pharmacologic Actions Anesthetics, Local Muscarinic Antagonists Phosphodiesterase Inhibitors Autonomic Agents Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |