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Nicotinic Receptors and Schizophrenia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00952393
First Posted: August 6, 2009
Last Update Posted: February 5, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VA Office of Research and Development
August 3, 2009
August 6, 2009
November 25, 2015
February 5, 2016
February 5, 2016
January 2010
October 2014   (Final data collection date for primary outcome measure)
Blood Levels of Drug [ Time Frame: 12 hours ]
This is the plasma level of the drug as determined by high performance liquid chromatography.
Blood Levels of Drug [ Time Frame: 12 hours ]
Complete list of historical versions of study NCT00952393 on ClinicalTrials.gov Archive Site
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Nicotinic Receptors and Schizophrenia
Nicotinic Receptors and Schizophrenia
The study determines if a new preparation of a drug designed to treat schizophrenia is more slowly released into the body.
3-2,4 dimethoxybenzylidene will be compounded with a methyallose compound in doses of 150 and 300 mg. The capsules will be administered singly and eventually bid to determine if sustained blood levels comparable to steady state blood levels seen in previous studies can be determined. Safety and EEG effects will be measured.
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Schizophrenia
Drug: Pharmacokinetic
Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined
Other Name: GTS-21
Pharmacokinetic
This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.
Intervention: Drug: Pharmacokinetic
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
October 2014
October 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy volunteers: males and females who are incapable of pregnancy

Exclusion Criteria:

  • Medical illnesses requiring acute treatment
  • History of seizures
  • Substance abuse including nicotine
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00952393
MHBB-005-09S
Yes
Not Provided
Not Provided
VA Office of Research and Development
VA Office of Research and Development
Not Provided
Principal Investigator: Robert Freedman, MD VA Eastern Colorado Health Care System, Denver
VA Office of Research and Development
January 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP