Phase 4 Schizophrenia Trial, Recruiting NCT03495024 Sponsor: Corporal Michael J. Crescenz VA Medical Center Condition: Schizophrenia
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Phase 4 Schizophrenia Trial, Recruiting

NCT03495024
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You have been diagnosed with schizophrenia or schizoaffective disorder, and your condition is currently stable
  • You have been diagnosed with a movement disorder called tardive dyskinesia (TD), assessed using a specific medical checklist (confirm with trial site)
  • You currently smoke at least 5 cigarettes per day on average, and have done so for at least the past 30 days
  • A breath test at the screening appointment shows a level of carbon monoxide above 5 parts per million, confirming you are a smoker
  • You are willing and able to set a quit date about four weeks after your first study appointment
  • Your mental health provider agrees that the stop-smoking medication used in this study (varenicline) is appropriate for you, or — if you do not have a mental health provider — the prescribing doctor has consulted with one on your behalf

Who may not be able to join:

  • You have any untreated or currently unstable physical or mental health conditions
  • You have a history of seizures or epilepsy
  • You have a history of sleepwalking
  • You have a long-term degenerative neurological condition, such as Parkinson's disease
  • You have used drugs or alcohol in a harmful way (including marijuana) in the past 3 months, or a drug test at screening comes back positive
  • You are currently taking the medications clozapine or cholinesterase inhibitors (a type of medication used for memory or thinking problems)
  • Your antipsychotic or anti-muscarinic medication dose or type was changed in the past month (or past two months if you use a long-acting injectable antipsychotic)
  • You are unable to stay on the same dose of your antipsychotic or anti-muscarinic medication throughout the study
  • You have had thoughts of suicide, plans, or attempts within the past 12 months, or a screening assessment shows significant levels of depression or anxiety
  • You are pregnant, or if you could become pregnant, you are not willing to use an approved form of contraception and have a negative pregnancy blood test at screening
  • You have taken part in another clinical drug trial within the past 30 days
  • You are currently using any other stop-smoking aids, such as bupropion or nicotine replacement products (e.g., patches, gum)
  • You currently use other tobacco products (e.g., cigars, chewing tobacco, or vaping products) (confirm with trial site)
  • You have had an allergic reaction to varenicline in the past
  • You are not able to give your own informed consent to take part in the study

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Stanley N Caroff, MD, Cpl. Michael J. Crescenz VA Medical Center

Phone: 215-823-4065

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Corporal Michael J. Crescenz VA Medical Center
Registry
ClinicalTrials.gov
Start date
1 January 2019
Est. completion
30 April 2020

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Self-reported 7-day point prevalence of abstinence prior to week 12

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov