Smoking cessation treatment for schizophrenia patients using varenicline
Effect of Varenicline on Smoking Cessation in Patients With Schizophrenia: Evaluation of Antipsychotic Drug-Induced Neurological Symptoms as Correlates of Response
This study is testing if the smoking cessation drug varenicline can help people with schizophrenia quit smoking while also managing their movement side effects from antipsychotic medications.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Corporal Michael J. Crescenz VA Medical Center Federal |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT03495024 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility of using varenicline to assist smoking cessation in patients with schizophrenia or schizoaffective disorder who are experiencing tardive dyskinesia due to antipsychotic medications. Over a 12-week period, 10 participants will undergo a smoking cessation program after a 2-week baseline assessment. The study will monitor changes in smoking status and neurological symptoms using standardized rating scales to determine if varenicline can reduce antipsychotic-induced neurological side effects without exacerbating acute symptoms. The findings may provide insights into the relationship between smoking cessation and neurological symptoms in this patient population.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with schizophrenia or schizoaffective disorder who are actively smoking and have pre-existing tardive dyskinesia.
Not a fit: Patients with untreated or unstable acute medical or psychiatric illnesses, or those with chronic degenerative neurological conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of neurological side effects in schizophrenia patients who smoke.
How similar studies have performed: While this approach is exploratory, similar studies have shown potential benefits of smoking cessation in improving neurological symptoms in other populations.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Corporal Michael J Crescenz VA Medical Center — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Stanley N Caroff, MD — Cpl. Michael J. Crescenz VA Medical Center
- Study coordinator: Stanley N Caroff, MD
- Email: stanley.caroff@va.gov
- Phone: 215-823-4065
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.