Evaluation of Impulsivity on Cocaine & Crack Addicts

Status Completed

Clinical Trial 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.

Clinical Trial 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01550887
Study type	Interventional
Source	Federal University of São Paulo
Contact
Status	Completed
Phase	N/A
Start date	April 2012
Completion date	May 2015

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Evaluation of Impulsivity on Cocaine and Crack Addicts

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms