Evaluation of Impulsivity on Cocaine and Crack Addicts

NCT ID: NCT01550887

Last Updated: 2015-08-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2015-05-31

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.

Conditions

Substance Dependence

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Impulsivity evaluation

Group Type: NO_INTERVENTION

No intervention

Intervention Type: OTHER

No intervention will be performed on this study

Interventions

No intervention

No intervention will be performed on this study

Intervention Type: OTHER

Other Intervention Names

No intervention will be performed on this study

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.

OTHER_GOV

Sponsor Role: collaborator

Associação Fundo de Incentivo à Pesquisa

OTHER

Sponsor Role: collaborator

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

JGalduroz

Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José C Galduróz, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de São Paulo

Locations

UDED

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

ANNA2011

Identifier Type: -

Identifier Source: org_study_id