Cocaine/Crack and Reduction of Compulsion With Biperiden

NCT ID: NCT01251393

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 111 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2012-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Biperiden

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

Group Type: EXPERIMENTAL

Biperiden

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Biperiden

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Group psychotherapy; Group psychotherapy

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Nacional Conseling of Scientific Development and Technology

OTHER

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Jose Carlos Fernandes Galduroz MD

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José C F. Galduróz

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de São Paulo

Locations

UDED - Drug Dependence Unit

São Paulo, , Brazil

Countries

Brazil

Other Identifiers

ACJC2010

Identifier Type: -

Identifier Source: org_study_id