Cocaine/Crack and Reduction of Compulsion With Biperiden

This study has been completed.
Sponsor:
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
ClinicalTrials.gov Identifier:
NCT01251393
First received: November 30, 2010
Last updated: November 23, 2012
Last verified: November 2012
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:


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

Primary Outcome Measures:
  • Compulsion score [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: JGalduroz, Dr., Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01251393     History of Changes
Other Study ID Numbers: ACJC2010
Study First Received: November 30, 2010
Last Updated: November 23, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
Cocaine
crack
treatment
dependence
biperiden

Additional relevant MeSH terms:
Compulsive Behavior
Cocaine-Related Disorders
Impulsive Behavior
Substance-Related Disorders
Mental Disorders
Biperiden
Cocaine
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Vasoconstrictor Agents
Cardiovascular Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Uptake Inhibitors
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents

ClinicalTrials.gov processed this record on July 29, 2014