Nicotinic Receptors and Schizophrenia

Completed · Phase 2 · Has a placebo group

Conditions studied: Schizophrenia, Schizoaffective Disorder

In brief

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.

Key facts

Study ID

NCT01400477

Run by

University of Colorado, Denver

People needed

97

Starts

2011-07-01

Expected to finish

2015-06-01

Last updated by the study team

2019-05-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects will be selected to be 18 to 65 years old and in good general health.
• Subjects who fulfill Diagnostic and Statistical Manual -IV-Text Revision (DSM-IV-TR) criteria for schizophrenia or schizoaffective disorder.
• Smokers will smoke at least 20 cigarettes per day.
• Non-smokers will also be enrolled.
• Subjects will have normal:
• vital signs,
• hematology,
• serum chemistries,
• EKG, and
• urinalysis with a negative drug screen before entry into the study.
• Subjects will be fluent in English.
• Smoking subjects will be interested in stopping smoking in the near future and not interested in nicotine replacement therapy.

You may not qualify if…

• Subjects with histories of:
• neurological illness,
• liver disease,
• severe hypertension (cut-off blood pressure 160/100) or
• cardiac disease, or
• renal failure (cut-off creatinine above 1.4).
• Subjects who currently meet DSM-IV-TR criteria for substance dependence other than nicotine, cannabis, or alcohol will be excluded.
• Women who are capable of pregnancy and not on acceptable forms of birth control will be excluded.
• Subjects being treated with Clozapine will be excluded.

Where it is running

• UColorado Denver — Aurora, Colorado, United States
• University of Colorado-Anschutz Medical Campus, Department of Psychiatry — Aurora, Colorado, United States

Full record on ClinicalTrials.gov

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