Back to resultsNicotinic Receptors and Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pharmacokinetic
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring receptors nicotinic
Eligibility Criteria
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
Sites / Locations
- VA Eastern Colorado Health Care System, Denver
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Pharmacokinetic
Arm Description
This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.
Outcomes
Primary Outcome Measures
Blood Levels of Drug
This is the plasma level of the drug as determined by high performance liquid chromatography.
Secondary Outcome Measures
Full Information
NCT ID
NCT00952393
First Posted
August 3, 2009
Last Updated
January 6, 2016
Sponsor
VA Office of Research and Development
1. Study Identification
Unique Protocol Identification Number
NCT00952393
Brief Title
Nicotinic Receptors and Schizophrenia
Official Title
Nicotinic Receptors and Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
receptors nicotinic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pharmacokinetic
Arm Type
Other
Arm Description
This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.
Intervention Type
Drug
Intervention Name(s)
Pharmacokinetic
Other Intervention Name(s)
GTS-21
Intervention Description
Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined
Primary Outcome Measure Information:
Title
Blood Levels of Drug
Description
This is the plasma level of the drug as determined by high performance liquid chromatography.
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Freedman, MD
Organizational Affiliation
VA Eastern Colorado Health Care System, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Eastern Colorado Health Care System, Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Nicotinic Receptors and Schizophrenia
We'll reach out to this number within 24 hrs