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

Recruiting in Palo Alto (17 mi)

Overseen by Stanley N Caroff, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: Corporal Michael J. Crescenz VA Medical Center

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Stanley N Caroff, MD

Principal Investigator

Cpl. Michael J. Crescenz VA Medical Center

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

Treatment Details

Interventions

• Varenicline (Smoking Cessation Agent)

Participant Groups

Group I: Smoking cessation with varenicline Experimental Treatment 1 Intervention

FDA-approved indication of varenicline for smoking cessation

Varenicline is already approved in Canada for the following indications:

Approved in Canada as Champix for:

• Smoking cessation

Who Is Running the Clinical Trial?

Corporal Michael J. Crescenz VA Medical Center

Lead Sponsor

Trials

31

Recruited

9,900+