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Evaluation of Impulsivity on Cocaine and Crack Addicts

Primary Purpose

Substance Dependence

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
No intervention
Sponsored by
Federal University of São Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Substance Dependence

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • UDED

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

Impulsivity evaluation

Arm Description

Outcomes

Primary Outcome Measures

Impulsive trait, as measured by different tests.
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.

Secondary Outcome Measures

Full Information

First Posted
December 12, 2011
Last Updated
August 10, 2015
Sponsor
Federal University of São Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Associação Fundo de Incentivo à Pesquisa
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1. Study Identification

Unique Protocol Identification Number
NCT01550887
Brief Title
Evaluation of Impulsivity on Cocaine and Crack Addicts
Official Title
Evaluation of Impulsivity on Cocaine and Crack Addicts
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of São Paulo
Collaborators
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior., Associação Fundo de Incentivo à Pesquisa

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Dependence

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Impulsivity evaluation
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
No intervention
Other Intervention Name(s)
No intervention will be performed on this study
Intervention Description
No intervention will be performed on this study
Primary Outcome Measure Information:
Title
Impulsive trait, as measured by different tests.
Description
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.
Time Frame
An expected average of 2 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
José C Galduróz, PhD
Organizational Affiliation
Universidade Federal de São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
UDED
City
São Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

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Evaluation of Impulsivity on Cocaine and Crack Addicts

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