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New treatment option for Schizophrenia
Official title Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates
ClinicalTrials.gov ID: NCT03495024
What this study is testing
What is Varenicline?
Varenicline is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for schizophrenia.
Also referred to as CHANTIX.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join 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
You likely can't join 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
See the full 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...
- 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 people 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
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.