NCT03495024 · Corporal Michael J. Crescenz VA Medical Center
Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates
What this study is about
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.
View original scientific description
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.
Interventions
DRUG
Varenicline
Oral medication approved to facilitate smoking cessation
Primary outcome measures
Self-reported 7-day point prevalence of abstinence prior to week 12
Time frame: 12 weeks
Self-reported 7-day point prevalence of abstinence prior to week 12
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Philadelphia, Pennsylvania
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
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Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
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Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 22, 2019 · Source of record for eligibility and locations