Pharmacological treatment of tardive dyskinesia: recent developments.
Stanley N Caroff, E Cabrina Campbell, Benjamin Carroll
https://pubmed.ncbi.nlm.nih.gov/28727483Actively Recruiting
Phase 4
Age: 18Years - 75Years
All Genders
ID03495024
Effect of Varenicline on Smoking Cessation in Patients With Schizophrenia Evaluating Neurological Side Effects from Antipsychotic Drugs
Led by Corporal Michael J. Crescenz VA Medical Center · Updated on 2019-03-22
10
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the effects of quitting smoking using varenicline on neurological side effects caused by antipsychotic drugs in patients with schizophrenia or schizoaffective disorder. This 12-week pilot study focuses on 10 smokers with pre-existing tardive dyskinesia who are on stable antipsychotic medication doses. The goal is to find out if stopping smoking with varenicline can reduce these neurological symptoms without worsening other movement-related side effects. Participants will begin the study with a 2-week baseline period to monitor symptoms and smoking habits. Varenicline treatment starts at a low dose and increases over the first two weeks, continuing for the remaining 9 weeks. Participants must stop smoking completely by week 6 and will attend several clinic visits for medication checks and symptom assessments throughout the study. During the study, researchers will regularly assess smoking status using questionnaires and carbon monoxide breath tests. Neurological symptoms will be measured with several rating scales, including the Simpson-Angus Scale and Abnormal Involuntary Movement Scale. Additional evaluations include psychiatric symptoms, cognitive tests, pregnancy tests for women, and monitoring of medication adherence and adverse events. The main outcome is the participant's smoking abstinence at 12 weeks, along with changes in smoking amount and neurological side effects.
CONDITIONS
Brief Title
Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosed with schizophrenia or schizoaffective disorder according to DSM 5 with stable disease
- Meet Glazer-Morgenstern-Doucette criteria for tardive dyskinesia
- Smoke at least 5 cigarettes daily on average for at least 30 days before screening
- Have an exhaled carbon monoxide level greater than 5 ppm at screening
- Agree to quit smoking by the target date four weeks after baseline
- Have approval for varenicline treatment from mental health provider or consulting clinician
You will not qualify if you...
- Untreated or unstable acute medical or psychiatric illnesses
- History of seizures
- History of somnambulism (sleepwalking)
- Chronic degenerative neurological diseases like Parkinson's disease
- Active substance abuse or positive toxicology in past 3 months
- Currently taking clozapine or cholinesterase inhibitors
- Recent changes in antipsychotic or anti-muscarinic medication dosing
- Unable to maintain a stable dose of antipsychotic or anti-muscarinic during study
- Suicidal ideation, intent, or behavior within 12 months or high risk per assessments
- Female participants of childbearing age must have negative pregnancy test and use birth control
- Use of investigational drugs within 30 days prior to screening
- Use of other smoking cessation aids or other tobacco products
- History of allergic reaction to varenicline
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - Up to 2 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Baseline Period
Duration - 2 weeks
Participants are observed for 2 weeks before starting treatment to assess smoking status and neurological symptoms.
1 visit (in-person)
Treatment
Duration - 12 weeks
Participants receive varenicline to support smoking cessation while being monitored for changes in neurological symptoms and smoking behavior.
Weekly visits for 5 weeks, then 1 visit at week 12
Trial Site Locations
Total: 1 location
1
Corporal Michael J Crescenz VA Medical Center
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
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Research Team
S
Stanley N Caroff, MD
R
Rosalind M Berkowitz, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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