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Completed

NCT Number: NCT01251393

Cocaine/Crack and Reduction of Compulsion With Biperiden

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.

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Key information

Conditions

Cocaine Dependence Chemically-Induced Disorders Cocaine-Related Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

UDED - Drug Dependence Unit

São Paulo, 04024-003, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biperiden

Drug

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

Other names: Group psychotherapy

Placebo

Drug

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

Other names: Group psychotherapy

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Collaborators

  • Nacional Conseling of Scientific Development and Technology

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2012
First posted
Dec 1, 2010
Registry last updated
Oct 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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