Status:
COMPLETED
Nicotinic Receptors and Schizophrenia
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 w...
Detailed 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 rec...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT01400477
Start Date
July 1 2011
End Date
June 1 2015
Last Update
May 7 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
UColorado Denver
Aurora, Colorado, United States, 80045
2
University of Colorado-Anschutz Medical Campus, Department of Psychiatry
Aurora, Colorado, United States, 80045