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RECRUITINGPhase 4INTERVENTIONAL

Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates

Effect of Varenicline on Smoking Cessation in Patients With Schizophrenia: Evaluation of Antipsychotic Drug-Induced Neurological Symptoms as Correlates of Response

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 willing to sign a consent form Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Varenicline

Oral medication approved to facilitate smoking cessation

Locations (1)

Corporal Michael J Crescenz VA Medical Center
Philadelphia, Pennsylvania, United States