RecruitingPhase 4NCT03495024

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


Sponsor

Corporal Michael J. Crescenz VA Medical Center

Enrollment

10 participants

Start Date

Jan 1, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether varenicline (a prescription quit-smoking pill) can help people with schizophrenia or schizoaffective disorder stop smoking, and whether it affects certain involuntary movement symptoms sometimes caused by antipsychotic medications. **You may be eligible if...** - You have been diagnosed with schizophrenia or schizoaffective disorder and your condition is currently stable - You smoke at least 5 cigarettes a day and have done so for at least the past month - You are willing to try to quit smoking about 4 weeks after the study begins - Your mental health provider agrees to the treatment, or a clinician can consult with one **You may NOT be eligible if...** - You have untreated or unstable physical or mental health problems - You have a history of seizures or sleepwalking - You have a degenerative neurological condition like Parkinson's disease - You have used substances (including marijuana) heavily in the past 3 months - You are currently taking clozapine or certain memory medications - Your antipsychotic medication dose or type was recently changed - You have had suicidal thoughts or attempts in the past 12 months - You are pregnant or not using a reliable form of birth control - You are currently using other quit-smoking aids like nicotine patches or bupropion - You have a known allergy to varenicline Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGVarenicline

Oral medication approved to facilitate smoking cessation


Locations(1)

Corporal Michael J Crescenz VA Medical Center

Philadelphia, Pennsylvania, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT03495024


Related Trials