Nicotinic Receptors and Schizophrenia

Tracking Information
First Submitted Date ICMJE	August 3, 2009
First Posted Date ICMJE	August 6, 2009
Results First Submitted Date	November 25, 2015
Results First Posted Date	February 5, 2016
Last Update Posted Date	February 5, 2016
Study Start Date ICMJE	January 2010
Actual Primary Completion Date	October 2014 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: January 6, 2016)	Blood Levels of Drug [ Time Frame: 12 hours ]; This is the plasma level of the drug as determined by high performance liquid chromatography.
Original Primary Outcome Measures ICMJE; (submitted: August 4, 2009)	Blood Levels of Drug [ Time Frame: 12 hours ]
Change History	Complete list of historical versions of study NCT00952393 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE	Not Provided
Original Secondary Outcome Measures ICMJE	Not Provided
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Nicotinic Receptors and Schizophrenia
Official Title ICMJE	Nicotinic Receptors and Schizophrenia
Brief Summary	The study determines if a new preparation of a drug designed to treat schizophrenia is more slowly released into the body.
Detailed Description	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.
Study Type ICMJE	Interventional
Study Phase	Phase 1
Study Design ICMJE	Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition ICMJE	Schizophrenia
Intervention ICMJE	Drug: Pharmacokinetic; Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined; Other Name: GTS-21
Study Arms	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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: January 14, 2013)	10
Original Estimated Enrollment ICMJE; (submitted: August 4, 2009)	20
Actual Study Completion Date	October 2014
Actual Primary Completion Date	October 2014 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult, Older Adult)
Accepts Healthy Volunteers	Yes
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	United States
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00952393
Other Study ID Numbers ICMJE	MHBB-005-09S
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	VA Office of Research and Development
Study Sponsor ICMJE	VA Office of Research and Development
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: Robert Freedman, MD VA Eastern Colorado Health Care System, Denver
PRS Account	VA Office of Research and Development
Verification Date	January 2016
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP