Cocaine/Crack and Reduction of Compulsion With Biperiden

Phase 3

Completed

• Conditions: Cocaine Dependence
• Interventions: Drug: Biperiden; Drug: Placebo

• Registration Number: NCT01251393
• Lead Sponsor: Federal University of São Paulo

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.

Study Timeline

• Study First Submitted: 2010-11-30
• Study First Submitted QC: 2010-11-30
• Study First Posted: 2010-12-01
• Study Start: 2011-05
• Primary Completion: 2011-12
• Study Completion: 2012-11
• Results First Submitted: 2019-02-12
• Results First Submitted QC: 2020-02-14
• Results First Posted: 2020-02-28
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-18
• Last Update Posted: 2020-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 111

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Compulsion	3 months	The patients answered the Minnesota Cocaine Craving Scale (Halikas et al., 1991).; INTENSITY: Evaluation of crack strength by cocaine in the previous week: Zero (no craving)---------------------------- -----10 (Intense craving); Ranges from 0 to 10 (zero = no craving; 10 intense craving). Using a rule starting from 0, we determine the number that corresponds to the compulsion. The farther from 0 the more intense the compulsion will be.; Frequency of craving onset: How many times a day 0 time/day - check: 0 point; 1. time/day - check: 1 point; 2. times/day - check: 2 points; 3. to 5 times/day - check: 3 points; 6 to 10 times/day - check: 4 points 11 to 20 times/day - check: 5 points more than 20 times/day - check: 6 points; Ranges from 0 to 6 points (zero = no craving; 1-2 points: Light; 3-4 points: moderate; 5- 6: intense craving).; The sum of the points of the subscales provides the final score.

Trial Locations

Locations (1)

UDED - Drug Dependence Unit; 🇧🇷 São Paulo, Brazil