Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 * Agree to stop smoking by the target date (four weeks after baseline * Concurrence for varenicline treatment from the patient's mental health provider if the patient is under mental health care; OR, if the patient is not under mental health care, the prescribing clinician should consult with a mental health provider to evaluate the patient for appropriateness to receive varenicline Exclusion Criteria: * 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) * Have a history of active substance abuse (including mariju