Schizophrenia Clinical Trial
Official title:
Effect of Varenicline on Smoking Cessation in Patients With Schizophrenia: Evaluation of Antipsychotic Drug-Induced Neurological Symptoms as Correlates of Response
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.
1. Objectives(s): To study whether smoking cessation with varenicline treatment will be
associated with a significant reduction in symptoms of antipsychotic-induced tardive
dyskinesia without worsening acute extrapyramidal symptoms.
2. Research Design: To test the feasibility of studying effects of smoking cessation with
varenicline on antipsychotic drug-induced neurological side effects, we propose a 12
week exploratory, open-label, proof-of-concept, 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.
3. Methodology: Patients will be evaluated at a Screening Visit 1 (Week 0) and at a
Baseline Visit 2 (Week 2) two weeks apart. After the Baseline Visit, subjects will be
asked to cease smoking completely by the target date four weeks after the baseline visit
(Week 6) and will attend a clinic Cessation Visit 4 (Week 6) for medication check and
resupply. Treatment with varenicline will start at Baseline Visit 2 (Week 2) with 0.5mg
hs x 3 days, 0.5mg bid x 4 days, then start 1mg bid at Visit 3 (Week 3) for the
remaining 9 weeks of the study.
At the Screening and Baseline Visits, and at study visits thereafter (Visit 3-7), subjects
will be evaluated for efficacy and safety, and changes in smoking or other tobacco use since
the last visit. The following measures will be taken; Fagerstrom Test for Cigarette
Dependence (FTCD) at screening only; Cigarette smoking will be assessed by a structured
questionnaire of time-line follow-back (TLFB) usage; Expired carbon using a hand-held carbon
monoxide monitor; Simpson-Angus Scale (SAS), Barnes Akathisia Scale (BAS), and the Abnormal
Involuntary Movement Scale (AIMS); Global Clinical Impression Scale (CGI-S at baseline, CGI-I
at final visit) for TD; C-SSRS; Brief Psychiatric Rating Scale (BPRS), Mini-Mental Status
Examination (MMSE) and Hospital Anxiety and Depression Scale (HADS) at baseline and the final
visit only; Brief smoking cessation counseling; Laboratory measures; Urine toxicology sample
at the screening and final visits only, serum pregnancy test (women) at screening visit only;
Changes in psychotropic medications; Varenicline compliance by pill counts; Adverse events.
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