Nicotinic Receptors and Schizophrenia

University of Colorado Denver (CU Denver)

Status and phase

Completed

Phase 2

Conditions

Schizophrenia

Schizoaffective Disorder

Treatments

Drug: DMXB-A-SR

Other: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01400477

VA Merit Review grant (Other Grant/Funding Number)

R01MH061412-05 (U.S. NIH Grant/Contract)

11-0459

5P50MH086383-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full description

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.

Enrollment

97 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.