Cocaine/Crack and Reduction of Compulsion With Biperiden

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

Cocaine consumption affects around 13.4 mi people or 0.3% of the world population between 15 and 64 years old. The drug dependence has been described by many authors as a dysfunction of the brain reward system. Considering the effects of the cholinergic system on the drug reward and self-administration mechanisms, acetylcholine (Ach) may play an important role on cocaine dependence process. Then the present study aims to evaluate biperiden efficacy (a cholinergic antagonist) in attenuate compulsion, one o the main symptoms of the drug dependence. To accomplish this purpose 60 cocaine or crack male users between 18 and 50 years old will be study. This is a double-blind controlled and randomized placebo study. All the patients will be treated with brief intervention therapy (BIT), and half of them will receive biperiden (6mg/day) while the other half will receive placebo. The treatment efficacy will be evaluated through the comparison between the values obtained on the following measures before and after the treatment: Craving scale of Minnesota and Cocaine/crack consumption questionnaire, and the presence of the cocaine metabolite (benzoylecgonine) on urine.

Condition or disease	Intervention/treatment	Phase
Cocaine Dependence; Crack Cocaine Dependence	Drug: Biperiden; Drug: Placebo	Phase 3

Study Design

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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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Biperiden; Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.	Drug: Biperiden; Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.
Placebo Comparator: Placebo; Thirty volunteers will take three pills of Placebo (6mg/day) during two months.	Drug: Placebo; Thirty volunteers will take three pills of Placebo (6mg/day) during two months.

Outcome Measures

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Primary Outcome Measures :

1. Compulsion score [ Time Frame: 24 months ]
   The complusion for cocaine/crack will be measured by Minessota Craving Scale and Cocaine/crack Consumption Scale

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 50 Years (Adult)
Sexes Eligible for Study:	Male
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Brazil
UDED - Drug Dependence Unit
São Paulo, Brazil, 04024-003

Sponsors and Collaborators

Federal University of São Paulo

Nacional Conseling of Scientific Development and Technology, Brazil

Association for Psychopharmacological Research, Brazil

Investigators

Principal Investigator:	José C F. Galduróz	Universidade Federal de São Paulo

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
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