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

Launched by CORPORAL MICHAEL J. CRESCENZ VA MEDICAL CENTER · Apr 4, 2018

Keywords

ClinConnect Summary

This clinical trial is investigating whether a medication called varenicline can help patients with schizophrenia or schizoaffective disorder quit smoking and if it can improve neurological symptoms caused by their antipsychotic medications. The study will last for 12 weeks and will involve 10 patients who smoke at least 5 cigarettes a day, have stable mental health, and experience a condition called tardive dyskinesia (uncontrolled movements due to long-term use of antipsychotics). Participants will be monitored for changes in their smoking habits and neurological symptoms after a two-week period of observation.

To be eligible for the trial, participants must be diagnosed with schizophrenia or schizoaffective disorder, have been smoking for at least a month, and agree to quit smoking within four weeks. They must also have approval from their mental health provider to use varenicline. Throughout the study, participants can expect regular check-ins to assess their progress and any side effects from the treatment. It's important to note that individuals with certain medical conditions, recent substance abuse, or those on specific medications may not qualify for the study. This trial aims to gather information that could lead to better treatment options for patients dealing with both smoking addiction and the side effects of antipsychotic medications.

Gender

ALL

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 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