Nicotinic Receptors and Schizophrenia

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: 3-(2,4-dimethoxybenzylidene)anabaseine

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.