RECRUITING

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

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Conditions

SchizophreniaSchizoaffective DisorderTobacco SmokingTardive DyskinesiaParkinsonismAntipsychotics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2019-01-01
Study Completion:2020-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03495024

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * DSM 5 criteria for schizophrenia or schizoaffective disorder and stable disease
  2. * Glazer-Morgenstern-Doucette criteria for TD
  3. * Smoking at least 5 cigarettes on average daily for at least 30 days prior to screening
  4. * An exhaled carbon monoxide concentration greater than 5 parts per million (ppm) at screening
  5. * Agree to stop smoking by the target date (four weeks after baseline
  6. * 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
  1. * Have untreated or unstable acute medical or psychiatric illnesses
  2. * Have a history of seizures
  3. * History of somnambulism
  4. * Have chronic degenerative neurological illnesses (e.g., Parkinson's disease)
  5. * Have a history of active substance abuse (including marijuana abuse) in the 3 months prior to screening or a positive toxicology screen
  6. * Are receiving clozapine or cholinesterase inhibitors
  7. * 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)
  8. * Are unable to remain on a stable dose of antipsychotic or anti-muscarinic during the study period
  9. * 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.
  10. * Female subjects of childbearing age will have a negative pregnancy serum test at screening and are required to use approved methods of birth control
  11. * Use of an investigational drug within 30 days of screening
  12. * Use of other smoking cessation aids (bupropion, nicotine replacement products)
  13. * Use of other tobacco products
  14. * History of allergic reactions to varenicline
  15. * Lack capacity to provide informed consent

Contacts and Locations

Study Contact

Stanley N Caroff, MD
CONTACT
215-823-4065
stanley.caroff@va.gov
Rosalind M Berkowitz, MD
CONTACT
215-823-4065
rosalind.berkowitz@va.gov

Principal Investigator

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

Study Locations (Sites)

Corporal Michael J Crescenz VA Medical Center
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Corporal Michael J. Crescenz VA Medical Center

  • Stanley N Caroff, MD, PRINCIPAL_INVESTIGATOR, Cpl. Michael J. Crescenz VA Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-01-01
Study Completion Date2020-06-30

Study Record Updates

Study Start Date2019-01-01
Study Completion Date2020-06-30

Terms related to this study

Keywords Provided by Researchers

  • Schizophrenia
  • Schizoaffective disorder
  • Antipsychotics
  • Tobacco smoking
  • Tardive dyskinesia
  • Parkinsonism

Additional Relevant MeSH Terms

  • Schizophrenia
  • Schizoaffective Disorder
  • Tobacco Smoking
  • Tardive Dyskinesia
  • Parkinsonism