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Nicotinic Receptors and Schizophrenia: Phase II
The investigators hypothesize that sustained-release DMXB-A-SR (3-2,4 dimethoxybenzylidene anabaseine sustained release) will provide clinical improvement in cognition in patients with schizophrenia who are smokers and who are non-smokers. The study drug may also maintain abstinence from cigarette smoking and improve other symptoms in patients with schizophrenia.
Patients with schizophrenia will be screened then enrolled for one week placebo trial in addition to their existing antipsychotic medication. If pill compliance is greater than 80%, then they will receive baseline clinical, cognitive, and brain imaging and all clinical laboratory examinations and a physical examination, vital signs, and cardiogram. Then patients will receive in a randomized double blind trial either DMXB-A-SR (3-2,4 dimethoxybenzylidene anabaseine sustained release) or placebo comparator in addition to their existing antipsychotic medication. After one month patients will receive repeat clinical, cognitive, and brain imaging testing and all clinical laboratory examinations and a physical examination, vital signs, and cardiogram.
Age
18 - 65 years
Sex
ALL
Healthy Volunteers
No
UColorado Denver
Aurora, Colorado, United States
University of Colorado-Anschutz Medical Campus, Department of Psychiatry
Aurora, Colorado, United States
Start Date
July 1, 2011
Primary Completion Date
June 1, 2015
Completion Date
June 1, 2015
Last Updated
May 7, 2019
97
ACTUAL participants
DMXB-A-SR
DRUG
Placebo
OTHER
Lead Sponsor
University of Colorado, Denver
Collaborators
NCT07455929
NCT06740383
Data Source & Attribution
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