💬In plain words
What the trial is, and whether it could suit you
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.
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📋 Eligibility rules (as published)
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 marijuana abuse) in the 3 months prior to screening or a positive toxicology screen
* Are receiving clozapine or cholinesterase inhibitors
* Had a change in dosing or medication type of antipsychotic or anti-muscarinic for one month prior to enrollment (two months for long-acting antipsychotics)
* Are unable to remain on a stable dose of antipsychotic or anti-muscarinic during the study period
* Have acute suicidal ideation, intent or behavior within 12 months or risk based assessed on the C-SSRS or depression/anxiety score ≥ 8 on the HADS.
* Female subjects of childbearing age will have a negative pregnancy serum test at screening and are required to use approved methods of birth control
* Use of an investigational drug within 30 days of screening
* Use of other smoking cessation aids (bupropion, nicotine replacement products)
* Use of other tobacco products
* History of allergic reactions to varenicline
* Lack capacity to provide informed consent
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