Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03495024|
Recruitment Status : Unknown
Verified March 2019 by Stanley N. Caroff, MD, Corporal Michael J. Crescenz VA Medical Center.
Recruitment status was: Recruiting
First Posted : April 11, 2018
Last Update Posted : March 22, 2019
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder Tobacco Smoking Tardive Dyskinesia Parkinsonism||Drug: Varenicline||Phase 4|
- Objectives(s): To study whether smoking cessation with varenicline treatment will be associated with a significant reduction in symptoms of antipsychotic-induced tardive dyskinesia without worsening acute extrapyramidal symptoms.
- Research Design: To test the feasibility of studying effects of smoking cessation with varenicline on antipsychotic drug-induced neurological side effects, we propose a 12 week exploratory, open-label, proof-of-concept, 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.
- Methodology: Patients will be evaluated at a Screening Visit 1 (Week 0) and at a Baseline Visit 2 (Week 2) two weeks apart. After the Baseline Visit, subjects will be asked to cease smoking completely by the target date four weeks after the baseline visit (Week 6) and will attend a clinic Cessation Visit 4 (Week 6) for medication check and resupply. Treatment with varenicline will start at Baseline Visit 2 (Week 2) with 0.5mg hs x 3 days, 0.5mg bid x 4 days, then start 1mg bid at Visit 3 (Week 3) for the remaining 9 weeks of the study.
At the Screening and Baseline Visits, and at study visits thereafter (Visit 3-7), subjects will be evaluated for efficacy and safety, and changes in smoking or other tobacco use since the last visit. The following measures will be taken; Fagerstrom Test for Cigarette Dependence (FTCD) at screening only; Cigarette smoking will be assessed by a structured questionnaire of time-line follow-back (TLFB) usage; Expired carbon using a hand-held carbon monoxide monitor; Simpson-Angus Scale (SAS), Barnes Akathisia Scale (BAS), and the Abnormal Involuntary Movement Scale (AIMS); Global Clinical Impression Scale (CGI-S at baseline, CGI-I at final visit) for TD; C-SSRS; Brief Psychiatric Rating Scale (BPRS), Mini-Mental Status Examination (MMSE) and Hospital Anxiety and Depression Scale (HADS) at baseline and the final visit only; Brief smoking cessation counseling; Laboratory measures; Urine toxicology sample at the screening and final visits only, serum pregnancy test (women) at screening visit only; Changes in psychotropic medications; Varenicline compliance by pill counts; Adverse events.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A 12 week exploratory, open-label, proof-of-concept, 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.|
|Masking:||None (Open Label)|
|Official Title:||Effect of Varenicline on Smoking Cessation in Patients With Schizophrenia: Evaluation of Antipsychotic Drug-Induced Neurological Symptoms as Correlates of Response|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||June 30, 2020|
Smoking cessation with varenicline
FDA-approved indication of varenicline for smoking cessation
Oral medication approved to facilitate smoking cessation
Other Name: CHANTIX
- 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
- A reduction in smoking was determined by a >50% reduction in mean number of cigarettes consumption per day at week 12 compared to baseline [ Time Frame: 12 weeks ]A reduction in smoking was determined by a >50% reduction in mean number of cigarettes consumption per day at week 12 compared to baseline
- Abstinence determined by a CO measure cutoff of ≤ 5 ppm [ Time Frame: 12 weeks ]Abstinence determined by a CO measure cutoff of ≤ 5 ppm
- Abstinence determined by 24-hour point prevalence at week 12 [ Time Frame: 12 weeks ]Abstinence determined by 24-hour point prevalence at week 12
- Percent of subjects showing Clinical Global Impression ratings of at least "much improved" [ Time Frame: 12 weeks ]Percent of subjects showing Clinical Global Impression ratings of at least "much improved"
- Percent of patients showing at least 50% improvement in AIMS score, [ Time Frame: 12 weeks ]Percent of patients showing at least 50% improvement in AIMS score,
- Mean change in the sum total of score on the AIMS (items 1-7) from the baseline to endpoint visits [ Time Frame: 12 weeks ]Mean change in the sum total of score on the AIMS (items 1-7) from the baseline to endpoint visits
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495024
|Contact: Stanley N Caroff, MDfirstname.lastname@example.org|
|Contact: Rosalind M Berkowitz, MDemail@example.com|
|United States, Pennsylvania|
|Corporal Michael J Crescenz VA Medical Center||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|Contact: Stanley N Caroff, MD 215-823-4065 firstname.lastname@example.org|
|Contact: Rosalind M Berkowitz, MD 215-823-4065 email@example.com|
|Principal Investigator:||Stanley N Caroff, MD||Cpl. Michael J. Crescenz VA Medical Center|