NCT03495024 Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates
| NCT ID | NCT03495024 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Corporal Michael J. Crescenz VA Medical Center |
| Condition | Schizophrenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2019-01-01 |
| Primary Completion | 2020-04-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 10 participants in total. It began in 2019-01-01 with a primary completion date of 2020-04-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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 * 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
Contact & Investigator
Stanley N Caroff, MD
PRINCIPAL INVESTIGATOR
Cpl. Michael J. Crescenz VA Medical Center
Frequently Asked Questions
Who can join the NCT03495024 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Schizophrenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT03495024 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT03495024 currently recruiting?
Yes, NCT03495024 is actively recruiting participants. Contact the research team at stanley.caroff@va.gov for enrollment information.
Where is the NCT03495024 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT03495024 clinical trial?
NCT03495024 is sponsored by Corporal Michael J. Crescenz VA Medical Center. The principal investigator is Stanley N Caroff, MD at Cpl. Michael J. Crescenz VA Medical Center. The trial plans to enroll 10 participants.
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