Clinical Trial

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

Recruiting Phase 4
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Record status
This record was last updated March 22, 2019 (before its estimated April 30, 2020 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2018-04-04; most recent amendment 2023-09-22.
Status change: Recruiting → Completed 2023-09-22
Status change: Not Yet Recruiting → Recruiting 2019-03-20
Trial Details
NCT Number NCT03495024
Lead Sponsor Corporal Michael J. Crescenz VA Medical Center
Conditions Schizophrenia, Schizoaffective Disorder, Tobacco Smoking, Tardive Dyskinesia, Parkinsonism
Enrollment 10 participants
Start Date 2019-01-01
Primary Completion 2020-04-30 (estimated)
Study Completion 2020-06-30 (estimated)
Updated on ClinicalTrials.gov 2019-03-22