NCT01251393

Cocaine/Crack and Reduction of Compulsion With Biperiden

Cocaine/Crack Dependence: A Study of the Possible Reduction of Compulsion Under the Use of Biperiden

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 111 (actual)
• Sponsor: Federal University of São Paulo · Academic / Other
• Sex: Male
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Cocaine Dependence

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2011-05-01
• Primary completion: 2011-12-01
• Completion: 2012-11-01
• First posted: 2010-12-01
• Last updated: 2020-10-14
• Results posted: 2020-02-28

Locations

1 site across 1 country: Brazil