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Cocaine/Crack and Reduction of Compulsion With Biperiden

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.
ClinicalTrials.gov Identifier: NCT01251393
Recruitment Status : Completed
First Posted : December 1, 2010
Last Update Posted : November 27, 2012
Information provided by (Responsible Party):

Study Description
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

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
Primary Completion Date : December 2011
Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

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

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

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

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
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 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:

Additional relevant MeSH terms:
Cocaine-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Biperiden lactate
Anesthetics, Local
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
Autonomic Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents