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Evaluation of Impulsivity on Cocaine and Crack Addicts

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ClinicalTrials.gov Identifier: NCT01550887
Recruitment Status : Completed
First Posted : March 12, 2012
Last Update Posted : August 13, 2015
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

Tracking Information
First Submitted Date  ICMJE December 12, 2011
First Posted Date  ICMJE March 12, 2012
Last Update Posted Date August 13, 2015
Study Start Date  ICMJE April 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 11, 2012)
Impulsive trait, as measured by different tests. [ Time Frame: An expected average of 2 months ]
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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 7, 2012)
Impulsive trait, as mesured by different tests. [ Time Frame: An expected average of 2 months ]
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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Impulsivity on Cocaine and Crack Addicts
Official Title  ICMJE Evaluation of Impulsivity on Cocaine and Crack Addicts
Brief Summary 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.
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Substance Dependence
Intervention  ICMJE Other: No intervention
No intervention will be performed on this study
Other Name: No intervention will be performed on this study
Study Arms  ICMJE No Intervention: Impulsivity evaluation
Intervention: Other: No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 7, 2012)
60
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01550887
Other Study ID Numbers  ICMJE ANNA2011
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party JGalduroz, Federal University of São Paulo
Study Sponsor  ICMJE Federal University of São Paulo
Collaborators  ICMJE
  • Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
  • Associação Fundo de Incentivo à Pesquisa
Investigators  ICMJE
Principal Investigator: José C Galduróz, PhD Universidade Federal de São Paulo
PRS Account Federal University of São Paulo
Verification Date August 2015

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