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

Recruiting now · Phase 4

Conditions studied: Schizophrenia, Schizoaffective Disorder, Tobacco Smoking, Tardive Dyskinesia, Parkinsonism

In brief

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.

Key facts

Study ID

NCT03495024

Run by

Corporal Michael J. Crescenz VA Medical Center

People needed

10

Starts

2019-01-01

Expected to finish

2020-06-30

Last updated by the study team

2019-03-22

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Corporal Michael J Crescenz VA Medical Center — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.