Cocaine/Crack and Reduction of Compulsion With Biperiden

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cocaine Dependence

Intervention / Treatment
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* Drug: Biperiden
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Biperiden<br>Thirty volunteers will take three pills of Biperiden (6mg/day) during two months. | Drug: Biperiden<br>* Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.<br>* Other names: Group psychotherapy;|
| Placebo Comparator: Placebo<br>Thirty volunteers will take three pills of Placebo (6mg/day) during two months. | Drug: Placebo<br>* Thirty volunteers will take three pills of Placebo (6mg/day) during two months.<br>* Other names: Group psychotherapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cocaine, crack, treatment, dependence, biperiden