Nicotinic Receptors and Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT00952393
First received: August 3, 2009
Last updated: January 6, 2016
Last verified: January 2016
Results First Received: November 25, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia
Intervention: Drug: Pharmacokinetic

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pharmacokinetic

This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.

Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined


Participant Flow:   Overall Study
    Pharmacokinetic  
STARTED     10 [1]
COMPLETED     10  
NOT COMPLETED     0  
[1] 10



  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.
This is a collection of volunteers from the health science community who responded to approved advertisements.

Reporting Groups
  Description
Pharmacokinetic

This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.

Pharmacokinetic: Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined


Baseline Measures
    Pharmacokinetic  
Number of Participants  
[units: participants]
  10  
Age [1]
[units: years]
Mean (Standard Deviation)
  31.7  (13.5)  
Gender [2]
[units: participants]
 
Female     3  
Male     7  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     4  
Not Hispanic or Latino     6  
Unknown or Not Reported     0  
Race (NIH/OMB) [3]
[units: participants]
 
American Indian or Alaska Native     0  
Asian     1  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     7  
More than one race     0  
Unknown or Not Reported     0  
Region of Enrollment [4]
[units: participants]
 
United States     10  
[1] Age in years as determine by asking the subject when their birthdate is.
[2] This is gender or sex as determined by inquiry from the subjects
[3] We ask the subjects to report their ethnicity.
[4] This is the area from which all the subjects come.



  Outcome Measures

1.  Primary:   Blood Levels of Drug   [ Time Frame: 12 hours ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Robert Freedman
Organization: University of Colorado
phone: 3037244940
e-mail: Robert.Freedman@ucdenver.edu



Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00952393     History of Changes
Other Study ID Numbers: MHBB-005-09S
Study First Received: August 3, 2009
Results First Received: November 25, 2015
Last Updated: January 6, 2016
Health Authority: United States: Federal Government