Evaluation of Impulsivity on Cocaine and Crack Addicts

This study is currently recruiting participants.
Verified November 2013 by Federal University of São Paulo
Sponsor:
Collaborators:
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Associação Fundo de Incentivo à Pesquisa
Information provided by (Responsible Party):
JGalduroz, Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01550887
First received: December 12, 2011
Last updated: November 21, 2013
Last verified: November 2013

December 12, 2011
November 21, 2013
April 2012
January 2014   (final data collection date for primary outcome measure)
Impulsive trait, as measured by different tests. [ Time Frame: An expected average of 2 months ] [ Designated as safety issue: No ]
To mesure "impulsive trait", will be used the Barratt Impulsivity Scale (BIS 11), the Reward Discounting Questionnaire and a computer-based Behavioral Test on "ProgRef v3" software.
Impulsive trait, as mesured by different tests. [ Time Frame: An expected average of 2 months ] [ Designated as safety issue: No ]
To mesure "impulsive trait", will be used the Barratt Impulsivity Scale (BIS 11), the Reward Discounting Questionnaire and a computer-based Behavioral Test on "ProgRef v3" software.
Complete list of historical versions of study NCT01550887 on ClinicalTrials.gov Archive Site
Not Provided
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Evaluation of Impulsivity on Cocaine and Crack Addicts
Evaluation of Impulsivity on Cocaine and Crack Addicts

This study main objective is investigating impulsivity on cocaine or crack addicts. The investigators main hypothesis is that different measures (such as scales or behavioral tasks, for example) of impulsivity may produce distinct outcomes, and they might also differ among cocaine (sniffed) and crack users. Thus, it would be of great value to compare such measures once these data are often interpreted as the same phenomenon.

Drug dependence is characterized by a sum of cognitive, behavioral and physiological symptoms. Among these symptoms are the lack of control over ones own behavior and substance use even in face of significant issues related to it. Impulsivity (expressed as impulsive choice or fail on behavioral inhibition) is important in crucial phases of drug dependence development. Both behavioral and neurobiological studies have confirmed the association between impulsivity and addictive behaviors. Thus a high impulsivity level might have influence on patients' treatment. Even though, several questions on this matter remain unclear for humans, such as the differences on impulsivity between users of different forms of cocaine (either sniffed or smoked). This kind of difference could establish distinct ways of treatment and then enable developing better treatments for drug users. For this study it will be recruited 60 non-treated dependent patients, among them 30 cocaine users and 30 crack users. These individuals will be selected based on DSM-IV dependence criteria. The instruments used will be scales to measure compulsion and consumption of cocaine/crack, a pharmacological screening for psychotropic drugs and a cognitive evaluation. As impulsivity measures are Barratt Impulsivity Scale (BIS 11), a reward discounting questionnaire and a computer-based behavioral test on "ProgRef v3" software. For data analysis the impulsivity measures will be compared with the behavioral and cognitive instruments through the Pearson's correlation matrix. An ANOVA will be also performed to verify any differences between cocaine and crack dependents on the impulsivity and compulsion tests. When it is appropriate subsequent Newman-Keuls post-hoc test will be performed. Significance level adopted is 0.05.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Substance Dependence
Other: No intervention
No intervention will be performed on this study
Other Name: No intervention will be performed on this study
No Intervention: Impulsivity evaluation
Intervention: Other: No intervention
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
May 2015
January 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male
  • 18-50 years old
  • Cocaine/ Crack dependence criteria according to DSM-IV
  • Have at least high school education level

Exclusion Criteria:

  • Present dependence criteria for other drugs, except for Nicotine/tabacco
  • Have any other psychiatric conditions
Male
18 Years to 50 Years
No
Contact: Maria L Formigoni, PhD 5511-5549-2500
Brazil
 
NCT01550887
ANNA2011
Yes
JGalduroz, Federal University of São Paulo
Federal University of São Paulo
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Associação Fundo de Incentivo à Pesquisa
Principal Investigator: José C Galduróz, PhD Universidade Federal de São Paulo
Federal University of São Paulo
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP