Evaluation of Impulsivity on Cocaine and Crack Addicts

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Substance Dependence
Other: No intervention

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Impulsivity on Cocaine and Crack Addicts

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 60
Study Start Date: April 2012
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Impulsivity evaluation Other: No intervention
No intervention will be performed on this study
Other Name: No intervention will be performed on this study

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01550887

Contacts
Contact: Maria L Formigoni, PhD 5511-5549-2500

Locations
Brazil
UDED Recruiting
São Paulo, SP, Brazil
Contact: Maria L Formigoni, PhD    5511-5549-2500      
Sponsors and Collaborators
Federal University of São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Associação Fundo de Incentivo à Pesquisa
Investigators
Principal Investigator: José C Galduróz, PhD Universidade Federal de São Paulo
  More Information

No publications provided

Responsible Party: JGalduroz, Dr., Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01550887     History of Changes
Other Study ID Numbers: ANNA2011
Study First Received: December 12, 2011
Last Updated: November 21, 2013
Health Authority: Brazil: Ethics Committee

Additional relevant MeSH terms:
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 22, 2014