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

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Schizophrenia
Intervention / Treatment

-

Contacts and Locations

Philadelphia

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

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Corporal Michael J. Crescenz VA Medical Center,

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

Study Record Dates

2020-06-30