Cocaine/Crack and Reduction of Compulsion With Biperiden
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ClinicalTrials.gov Identifier: NCT01251393 |
Recruitment Status
:
Completed
First Posted
: December 1, 2010
Last Update Posted
: November 27, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cocaine Dependence Crack Cocaine Dependence | Drug: Biperiden Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Cocaine/Crack Dependence: A Study of the Possible Reduction of Compulsion Under the Use of Biperiden |
Study Start Date : | May 2011 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | November 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: Biperiden
Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.
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Drug: Biperiden
Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.
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Placebo Comparator: Placebo
Thirty volunteers will take three pills of Placebo (6mg/day) during two months.
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Drug: Placebo
Thirty volunteers will take three pills of Placebo (6mg/day) during two months.
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- Compulsion score [ Time Frame: 24 months ]The complusion for cocaine/crack will be measured by Minessota Craving Scale and Cocaine/crack Consumption Scale

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Cocaine or crack dependence, according to the DSM-IV criteria (APA, 1994)
Exclusion Criteria:
- Being under treatment with psychoactive drugs
- Have been diagnosed for other Psychiatric Disorders
- Have dependence diagnosis for other drugs, except for tabacco

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01251393
Brazil | |
UDED - Drug Dependence Unit | |
São Paulo, Brazil, 04024-003 |
Principal Investigator: | José C F. Galduróz | Universidade Federal de São Paulo |
Responsible Party: | JGalduroz, Dr., Federal University of São Paulo |
ClinicalTrials.gov Identifier: | NCT01251393 History of Changes |
Other Study ID Numbers: |
ACJC2010 |
First Posted: | December 1, 2010 Key Record Dates |
Last Update Posted: | November 27, 2012 |
Last Verified: | November 2012 |
Keywords provided by JGalduroz, Federal University of São Paulo:
Cocaine crack treatment dependence biperiden |
Additional relevant MeSH terms:
Cocaine-Related Disorders Substance-Related Disorders Chemically-Induced Disorders Mental Disorders Cocaine Biperiden Biperiden lactate Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Vasoconstrictor Agents |
Dopamine Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Dopamine Agents Neurotransmitter Agents Antiparkinson Agents Anti-Dyskinesia Agents Parasympatholytics Autonomic Agents Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents |