Clinical trial NCT01550887: Evaluation of Impulsivity on Cocaine and Crack Addicts
Official title: Evaluation of Impulsivity on Cocaine and Crack Addicts
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Dependence
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
name: Associação Fundo de Incentivo à Pesquisa
First posted: 2012-03-12
Enrollment: 60
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Impulsive trait, as measured by different tests.
timeFrame: An expected average of 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: UDED
state: SP
Study officials:
affiliation: Universidade Federal de São Paulo
name: José C Galduróz, PhD
role: PRINCIPAL_INVESTIGATOR
References: