Cocaine/Crack and Reduction of Compulsion With Biperiden

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01251393

First Posted: December 1, 2010

Last Update Posted: November 27, 2012

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Collaborators:

Nacional Conseling of Scientific Development and Technology, Brazil

Association for Psychopharmacological Research, Brazil

Information provided by (Responsible Party):

JGalduroz, Federal University of São Paulo

Purpose

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	Intervention	Phase
Cocaine Dependence Crack Cocaine Dependence	Drug: Biperiden Drug: Placebo	Phase 3


Study Type:	Interventional
Study Design:	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

Resource links provided by NLM:

Drug Information available for: Cocaine hydrochloride

U.S. FDA Resources

Further study details as provided by JGalduroz, Federal University of São Paulo:

Primary Outcome Measures:

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


Estimated Enrollment:	60
Study Start Date:	May 2011
Study Completion Date:	November 2012
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

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

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


Responsible Party:	JGalduroz, Dr., Federal University of São Paulo
ClinicalTrials.gov Identifier:	NCT01251393 History of Changes
Other Study ID Numbers:	ACJC2010
First Submitted:	November 30, 2010
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

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