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Nicotinic Receptors and Schizophrenia

This study has been completed.
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: August 3, 2009
Last updated: January 6, 2016
Last verified: January 2016
The study determines if a new preparation of a drug designed to treat schizophrenia is more slowly released into the body.

Condition Intervention Phase
Drug: Pharmacokinetic
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nicotinic Receptors and Schizophrenia

Resource links provided by NLM:

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • Blood Levels of Drug [ Time Frame: 12 hours ]
    This is the plasma level of the drug as determined by high performance liquid chromatography.

Enrollment: 10
Study Start Date: January 2010
Study Completion Date: October 2014
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
This single arm examines the pharmaco-kinetics of the release of 3-2,4 dimethoxy-benzilidene anabaseine in a hypomellose sustained release formulation.
Drug: Pharmacokinetic
Subject receives 150 mg of compound formulated with hypomellose and Pharmcokinetics is determined
Other Name: GTS-21

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.

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00952393

United States, Colorado
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, United States, 80220
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Robert Freedman, MD VA Eastern Colorado Health Care System, Denver
  More Information

Responsible Party: VA Office of Research and Development 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

Keywords provided by VA Office of Research and Development:
receptors nicotinic

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders processed this record on May 25, 2017