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.
DSM 5 criteria for schizophrenia or schizoaffective disorder and stable disease
Glazer-Morgenstern-Doucette criteria for TD
Smoking at least 5 cigarettes on average daily for at least 30 days prior to screening
An exhaled carbon monoxide concentration greater than 5 parts per million (ppm) at screening
Have untreated or unstable acute medical or psychiatric illnesses
Have a history of seizures
History of somnambulism
Have chronic degenerative neurological illnesses (e.g., Parkinson's disease)
Single group
Varenicline
DrugOral medication approved to facilitate smoking cessation
Self-reported 7-day point prevalence of abstinence prior to week 12
Self-reported 7-day point prevalence of abstinence prior to week 12
A reduction in smoking was determined by a >50% reduction in mean number of cigarettes consumption per day at week 12 compared to baseline
A reduction in smoking was determined by a \>50% reduction in mean number of cigarettes consumption per day at week 12 compared to baseline
Abstinence determined by a CO measure cutoff of ≤ 5 ppm
Abstinence determined by a CO measure cutoff of ≤ 5 ppm
Abstinence determined by 24-hour point prevalence at week 12
Abstinence determined by 24-hour point prevalence at week 12
Percent of subjects showing Clinical Global Impression ratings of at least "much improved"
Percent of subjects showing Clinical Global Impression ratings of at least "much improved"
Percent of patients showing at least 50% improvement in AIMS score,
Percent of patients showing at least 50% improvement in AIMS score,
Mean change in the sum total of score on the AIMS (items 1-7) from the baseline to endpoint visits
Mean change in the sum total of score on the AIMS (items 1-7) from the baseline to endpoint visits
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