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

Learn more about:
Related Clinical Trial
Efficacy Study of Panax Ginseng to Boost Antipsychotics Effects in Schizophrenia The Potential for Clinical Dependence and Withdrawal Symptoms Associated With Valbenazine Dysport for the Treatment of OMD Validation of the Implantation of a New Electrode for the Treatment of Dystonia Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates Safety and Tolerability Study of NBI-98854 for the Treatment of Tardive Dyskinesia Randomized Controlled Trial of Pyridoxine for Tardive Dyskinesia D-Serine Treatment For Tardive Dyskinesia Deep Brain Stimulation for Patients With Tardive Dyskinesia and or Dystonia Persistence of Effect and Safety of Valbenazine for the Treatment of Tardive Dyskinesia Levetiracetam Treatment of Tardive Dyskinesia The Assessment of Movement Disorders Utilizing Live Two-Way Video Real‐World Evaluation Screening Study and Registry of Dyskinesia in Patients Taking Antipsychotic Agents Xenazine in Late Dyskinetic Syndrome With Neuroleptics Safety and Efficacy of Propranolol in the Treatment of Tardive Dyskinesia Effect of tDCS on Cognition, Symptoms in Chronic Schizophrenia Patients With Tardive Dyskinesia Melatonin Treatment for Tardive Dyskinesia in Schizophrenia Extract of Ginkgo Biloba and Tardive Dyskinesia Aim to Reduce Movements in Tardive Dyskinesia Reducing Involuntary Movements in Tardive Dyskinesia A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia Pyridoxal Kinase Activity in Tardive Dyskinesia Rollover Study for Continuing Valbenazine (NBI-98854) Administration for the Treatment of Tardive Dyskinesia NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder (KINECT Study) NBI-98854 for the Treatment of Tardive Dyskinesia in Subjects With Schizophrenia or Schizoaffective Disorder Repetitive Transcranial Magnetic Stimulation for the Treatment of the Tardive Dyskinesia. Efficacy and Safety of NBI-98854 in Subjects With Tardive Dyskinesia Efficacy and Safety of MT-5199 in Subjects With Tardive Dyskinesia Piracetam for Treatment Tardive Dyskinesia Treatment of Tardive Dyskinesia With Galantamine Tardive Dyskinesia and Cognitive Function Safety and Efficacy of Pyridoxal 5′ -Phosphate in the Treatment of Tardive Dyskinesia Addressing Involuntary Movements in Tardive Dyskinesia Efficacy of Docosahexaenoic Acid on Tardive Dyskinesia

Brief Title

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

Official Title

Effect of Varenicline on Smoking Cessation in Patients With Schizophrenia: Evaluation of Antipsychotic Drug-Induced Neurological Symptoms as Correlates of Response

Brief 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.
    

Detailed Description

      1. 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.

        2. 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.

        3. 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 Phase

Phase 4

Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 A reduction in smoking was determined by a >50% reduction in mean number of cigarettes consumption per day at week 12 compared to baseline

Condition

Schizophrenia

Intervention

Varenicline

Study Arms / Comparison Groups

 Smoking cessation with varenicline
Description:  FDA-approved indication of varenicline for smoking cessation

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

10

Start Date

January 1, 2019

Completion Date

June 30, 2020

Primary Completion Date

April 30, 2020

Eligibility Criteria

        Inclusion Criteria:

          -  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 Criteria:

          -  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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Stanley N Caroff, MD, 215-823-4065, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03495024

Organization ID

01730


Responsible Party

Principal Investigator

Study Sponsor

Corporal Michael J. Crescenz VA Medical Center


Study Sponsor

Stanley N Caroff, MD, Principal Investigator, Cpl. Michael J. Crescenz VA Medical Center


Verification Date

March 2019