An Eval of Neurocognitive Function, Oxidative Damage, and Their Association With Outcomes in METH and Cocaine Abusers.

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Theresa Winhusen, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT00628927
First received: March 3, 2008
Last updated: July 22, 2013
Last verified: May 2013
Results First Received: May 3, 2013  
Study Type: Observational
Study Design: Observational Model: Case Control;   Time Perspective: Cross-Sectional
Condition: Stimulant Dependence

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
As an ancillary study to CTN-0031, six of the nine sites participating in CTN-0031 were chosen to participate in the present study. At the participating sites, participants who were randomized into CTN-0031 were eligible to be screened for the present study. Normal controls were recruited via advertising from one study site.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
6 stimulant abusers met at least one exclusion criterion, 3 for a history of stroke and 3 for a history of seizures. 2 of those 6 were incorrectly enrolled into the study. The most common exclusion criteria met by the normal control screeners was having a DSM-IV substance use diagnosis and positive urine toxicology screen.

Reporting Groups
  Description
Simulant Dependent Participants Stimulant Dependent pts entering treatment who are also enrolled in CTN0031
Normal Control Participants Normal Control participants recruited from the community

Participant Flow:   Overall Study
    Simulant Dependent Participants     Normal Control Participants  
STARTED     183     30  
COMPLETED     175     30  
NOT COMPLETED     8     0  
Problems performing blood draw                 6                 0  
Lost to Follow-up                 1                 0  
Equipment failure                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Stimulant dependent participants were starting treatment, and participating in the CTN0031 study. Normal controls were recruited from the community.

Reporting Groups
  Description
Simulant Dependent Participants Stimulant Dependent pts entering treatment who are also enrolled in CTN0031
Normal Control Participants Normal Control participants recruited from the community
Total Total of all reporting groups

Baseline Measures
    Simulant Dependent Participants     Normal Control Participants     Total  
Number of Participants  
[units: participants]
  183     30     213  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     183     30     213  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  38.6  ± 9.3     44.5  ± 9.5     39.4  ± 9.5  
Gender  
[units: participants]
     
Female     125     17     142  
Male     58     13     71  
Region of Enrollment  
[units: participants]
     
United States     183     30     213  



  Outcome Measures
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1.  Primary:   Stroop Color-word Task   [ Time Frame: Single study visit ]

2.  Secondary:   Barrett Impulsiveness Scale Version 11 (BIS-11)   [ Time Frame: Single study visit ]

3.  Secondary:   Tail Length From the Comet Assay for Oxidative Damage   [ Time Frame: Single study visit ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Theresa Winhusen
Organization: University of Cincinnati
phone: 513-487-7800
e-mail: winhusen@carc.uc.edu


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Theresa Winhusen, University of Cincinnati
ClinicalTrials.gov Identifier: NCT00628927     History of Changes
Other Study ID Numbers: NIDA-CTN-0031A, 5U10DA013732, U10DA013732
Study First Received: March 3, 2008
Results First Received: May 3, 2013
Last Updated: July 22, 2013
Health Authority: United States: Federal Government