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)