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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
History of Changes

November 30, 2010
November 23, 2012
May 2011
December 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01251393 on ClinicalTrials.gov Archive Site
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Cocaine/Crack and Reduction of Compulsion With Biperiden
Cocaine/Crack Dependence: A Study of the Possible Reduction of Compulsion Under the Use of Biperiden

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.
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Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Cocaine Dependence
  • Crack Cocaine Dependence
  • Drug: Biperiden
    Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.
  • Drug: Placebo
    Thirty volunteers will take three pills of Placebo (6mg/day) during two months.
  • Experimental: Biperiden
    Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.
    Intervention: Drug: Biperiden
  • Placebo Comparator: Placebo
    Thirty volunteers will take three pills of Placebo (6mg/day) during two months.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
November 2012
December 2011   (final data collection date for primary outcome measure)

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
Male
18 Years to 50 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01251393
ACJC2010
Yes
JGalduroz, Federal University of São Paulo
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
Federal University of São Paulo
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP