Phase 4
N=14
Varenicline Effects In Schizophrenic Smokers
Schizophrenia · Tobacco Use Disorder · Nicotine Dependance
Bottom Line
View on ClinicalTrials.gov: NCT00548470 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Sep 2017
Primary outcome: Primary: Self Report of Smoking — 36.45; 17.25; 12.52 Cigarettes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Varenicline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Nathan Kline Institute for Psychiatric Research
- Primary completion
- Sep 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Self Report of Smoking |
36.45; 17.25; 12.52 | — |
| PRIMARY CO (Carbon Monoxide) Breathalyzer Level |
8.97; 5.7; 4.85 | — |
| PRIMARY Plasma Cotinine |
362.25; 181.75; 200.25 | — |
| SECONDARY RBANS Neuropsychological Battery |
59.00; 59.17; 15.75; 19.50; 73.58; 63.50 | — |
| SECONDARY Change From Baseline in Psychiatric Symptoms |
56.57; 55.58; 12.58; 12.00 | — |
Summary
This is an open label pre-post study of the effects of clinical treatment with varenicline on 1) decreasing smoking in schizophrenic patients, 2) improving selected cognitive measures in schizophrenic patients, and 3) psychopathology in schizophrenic patients. Patients are assessed on subjective and objective measures of smoking, selected cognitive measures, and special chemical measures, during baseline testing and during 8 weeks of treatment with varenicline (1-2 mg/day).
Eligibility Criteria
Inclusion Criteria
- Clinical Diagnosis of Schizophrenia or Schizoaffective Psychosis
- Recent History of Cigarette smoking
- Ages 18-65
Data sourced from ClinicalTrials.gov (NCT00548470). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.