Actively Recruiting
Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates
Led by Corporal Michael J. Crescenz VA Medical Center · Updated on 2019-03-22
10
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
To test the feasibility of studying effects of smoking cessation with varenicline on antipsychotic drug-induced neurological side effects, we propose a 12 week pilot study of smoking cessation treatment with varenicline in 10 schizophrenia or schizoaffective disorder patients who are actively smoking and have pre-existing TD while receiving stable doses of antipsychotics. Subjects will be followed after a 2 week baseline period to assess changes in smoking status and neurological symptoms using standardized rating scales. The aim is to examine clinically significant effects on antipsychotic-induced neurological side effects that may warrant further investigation.
CONDITIONS
Official Title
Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of schizophrenia or schizoaffective disorder with stable disease
- Diagnosis of tardive dyskinesia by Glazer-Morgenstern-Doucette criteria
- Smoking at least 5 cigarettes daily for at least 30 days before screening
- Exhaled carbon monoxide level over 5 ppm at screening
- Willingness to stop smoking by four weeks after baseline
- Approval for varenicline treatment from the patient's mental health provider or consulting provider
You will not qualify if you...
- Untreated or unstable acute medical or psychiatric illness
- History of seizures or sleepwalking
- Chronic degenerative neurological diseases such as Parkinson's disease
- Active substance abuse or positive toxicology within 3 months prior to screening
- Current use of clozapine or cholinesterase inhibitors
- Recent change in antipsychotic or anti-muscarinic medication within 1 to 2 months
- Inability to maintain stable doses of antipsychotic or anti-muscarinic drugs during the study
- Acute suicidal thoughts or behavior within the past 12 months or high depression/anxiety scores
- Positive pregnancy test for women of childbearing age and requirement for birth control
- Use of investigational drugs within 30 days of screening
- Use of other smoking cessation aids or tobacco products
- Allergic reaction history to varenicline
- Inability to provide informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Corporal Michael J Crescenz VA Medical Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
S
Stanley N Caroff, MD
CONTACT
R
Rosalind M Berkowitz, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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