Cocaine/Crack and Reduction of Compulsion With Biperiden

Federal University of São Paulo

Status and phase: Completed; Phase 3

Conditions: Cocaine Dependence

Treatments: Drug: Placebo; Drug: Biperiden

Study type: Interventional

Funder types: Other

Identifiers

NCT01251393

ACJC2010

Details and patient eligibility

About

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.

Full 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.

Enrollment: 111 patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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111 participants in 2 patient groups, including a placebo group

Biperiden

Experimental group

Description:

Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.

Treatment:

Drug: Biperiden

Placebo

Placebo Comparator group

Description:

Thirty volunteers will take three pills of Placebo (6mg/day) during two months.

Treatment:

Drug: Placebo