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Smoking Cessation with Varenicline in Schizophrenia and Schizoaffective Disorder

This study is looking at whether an approved smoking cessation medication, varenicline, can help people with schizophrenia or schizoaffective disorder who smoke and also have movement problems (tardive dyskinesia) caused by their antipsychotic medications. Researchers want to see if quitting smoking with varenicline might reduce these neurological symptoms. You could be eligible if you are 18-75 years old, have schizophrenia or schizoaffective disorder, smoke at least 5 cigarettes daily, and have tardive dyskinesia. The main goal is to see if participants report not smoking for 7 days by the end of the 12-week study. The current status of this study is unclear, and it plans to enroll 10 participants.

Study design
This is a small, exploratory pilot study with 10 participants. It is an open-label study, meaning both you and the researchers will know you are receiving varenicline.
What's involved
You would have a screening visit, a baseline visit, and then start taking varenicline. You would be asked to stop smoking completely about four weeks after starting the medication, and there would be a cessation visit around that time. The study lasts for 12 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your smoking status will be checked at 12 weeks, which is the end of the study period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT03495024

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

Recruiting
PHASE4Ages 18–75InterventionalTreatment
Corporal Michael J. Crescenz VA Medical Center
~10 participants
Updated 2019-03-22 on ClinicalTrials.gov
What's tested:Varenicline

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Self-reported 7-day point prevalence of abstinence prior to week 12
Measured over 12 weeks

Conditions

Schizophrenia
Schizoaffective Disorder
Tobacco Smoking
Tardive Dyskinesia
Parkinsonism

Explore related trials

Schizoaffective DisorderSchizophrenia

Where it's being run

1 sites across 1 states
Pennsylvania1

Study leadership

  • Stanley N Caroff, MD · PRINCIPAL_INVESTIGATOR · Cpl. Michael J. Crescenz VA Medical Center

Who to contact

Stanley N Caroff, MD
[email protected]
215-823-4065
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Self-reported 7-day point prevalence of abstinence prior to week 1212 weeks

    Self-reported 7-day point prevalence of abstinence prior to week 12