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NCT03495024 · ClinicalTrials.gov registry record · Phase 4
Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates
A Phase 4 study of Schizophrenia and Schizoaffective Disorder, sponsored by Corporal Michael J. Crescenz VA Medical Center.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03495024: Recruiting Phase 4 study of Schizophrenia and Schizoaffective Disorder, sponsored by Corporal Michael J. Crescenz VA Medical Center.
NCT03495024 is a Phase 4 study of Schizophrenia and Schizoaffective Disorder that is actively recruiting participants, run by Corporal Michael J. Crescenz VA Medical Center. The registered enrollment target is 10 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03495024, a Phase 4 study of Schizophrenia and Schizoaffective Disorder, is actively recruiting participants, sponsored by Corporal Michael J. Crescenz VA Medical Center.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Self-reported 7-day point prevalence of abstinence prior to week 12
Conditions Studied
Interventions
- DRUG Varenicline
Study Locations (1)
Pennsylvania
- Corporal Michael J Crescenz VA Medical Center - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-01-01 |
| Est. Completion | 2020-06-30 |
| Phase | Phase 4 |
What NCT03495024 shows while recruiting
NCT03495024 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (95% lower).
The record links to 5 conditions, with Schizophrenia appearing as the primary indexed condition, and to 1 intervention - of which Varenicline is the first listed.
NCT03495024 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT03495024 about?
NCT03495024 is a clinical study titled "Smoking Cessation With Varenicline in Schizophrenia: Antipsychotic-Induced Neurological Symptoms as Correlates". 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 smokin...
What is the current status of trial NCT03495024?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2019-01-01. Estimated completion is 2020-06-30.
What conditions does trial NCT03495024 study?
This clinical trial studies the following conditions: Schizophrenia, Schizoaffective Disorder, Tobacco Smoking, Tardive Dyskinesia, Parkinsonism.
What interventions are being tested in trial NCT03495024?
The interventions under investigation include: Varenicline (DRUG).
Who is sponsoring clinical trial NCT03495024?
This trial is sponsored by Corporal Michael J. Crescenz VA Medical Center, which has 13 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03495024 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Schizophrenia
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03495024's enrollment target sits among peer trials
10 309th of 315 higher than 4 of 315 other Schizophrenia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Schizophrenia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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