Cocaine/Crack and Reduction of Compulsion With Biperiden

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: December 2011

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Biperiden
    • Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.
  • Placebo Comparator: Placebo
    • Thirty volunteers will take three pills of Placebo (6mg/day) during two months.

Clinical Trial Outcome Measures

Primary Measures

  • Compulsion
    • Time Frame: 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 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.

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of São Paulo
  • Collaborator
    • Nacional Conseling of Scientific Development and Technology
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jose Carlos Fernandes Galduroz MD, Dr. – Federal University of São Paulo
  • Overall Official(s)
    • José C F. Galduróz, Principal Investigator, Universidade Federal de São Paulo

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