NCT01550887

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 12, 2011

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 12, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2012

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

August 13, 2015

Status Verified

August 1, 2015

Enrollment Period

1.8 years

First QC Date

December 12, 2011

Last Update Submit

August 10, 2015

Conditions

Substance Dependence

Outcome Measures

Primary Outcomes (1)

  • 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.

    An expected average of 2 months

Study Arms (1)

Impulsivity evaluation

NO INTERVENTION
Other: No intervention

Interventions

No interventionOTHER

No intervention will be performed on this study

Also known as: No intervention will be performed on this study
Impulsivity evaluation

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male
  • years old
  • Cocaine/ Crack dependence criteria according to DSM-IV
  • Have at least high school education level

You may not qualify if:

  • Present dependence criteria for other drugs, except for Nicotine/tabacco
  • Have any other psychiatric conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UDED

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • José C Galduróz, PhD

    Universidade Federal de São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

December 12, 2011

First Posted

March 12, 2012

Study Start

April 1, 2012

Primary Completion

January 1, 2014

Study Completion

May 1, 2015

Last Updated

August 13, 2015

Record last verified: 2015-08

Locations

BR(1)