Cocaine/Crack and Reduction of Compulsion With Biperiden

Cocaine Dependence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01251393
• Other study ID #: ACJC2010
• Status: Completed
• Phase: Phase 3
• Start date: May 2011
• Est. completion date: November 2012

Study information

• Verified date: September 2020
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 111
• Est. completion date: November 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cocaine Dependence
• Cocaine-Related Disorders

Intervention

Drug:
• Biperiden
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.

Locations

Country	Name	City	State
Brazil	UDED - Drug Dependence Unit	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Nacional Conseling of Scientific Development and Technology

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compulsion	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; time/day - check: 1 point; times/day - check: 2 points; 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.	3 months