Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Nicotinic Receptors and Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00952393
First received: August 3, 2009
Last updated: December 4, 2014
Last verified: December 2014

August 3, 2009
December 4, 2014
January 2010
October 2014   (final data collection date for primary outcome measure)
Blood levels of drug [ Time Frame: 12 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00952393 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Schizophrenia
Drug: 3-2,4 dimethoxbenzylidene anabaseine
nicotinic agonist
Arm 1
Intervention: Drug: 3-2,4 dimethoxbenzylidene anabaseine
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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00952393
MHBB-005-09S
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Robert Freedman, MD VA Eastern Colorado Health Care System, Denver
Department of Veterans Affairs
December 2014

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