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NCT01111149 · ClinicalTrials.gov registry record · Phase 2
Varenicline and Smoking Cessation in Schizophrenia
A Phase 2 study of Schizophrenia and Smoking Cessation, sponsored by University of Minnesota.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT01111149: Completed Phase 2 study of Schizophrenia and Smoking Cessation, sponsored by University of Minnesota.
NCT01111149 is a Phase 2 study of Schizophrenia and Smoking Cessation that has completed, run by University of Minnesota. The registered enrollment target is 24 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01111149, a Phase 2 study of Schizophrenia and Smoking Cessation, has completed, sponsored by University of Minnesota.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
There is a strong association between smoking and schizophrenia with prevalence rates ranging from 74% to 90%, versus a national average of 30% in nonschizophrenic individuals. A number of hypotheses have been proposed to explain the relationship between high smoking rates and schizophrenia, mostly relating to self-medication primarily for the negative symptoms of schizophrenia. Smoking cessation rates among schizophrenic patients are considerably lower than for other psychiatric disorders. The negative health effects of smoking increase the morbidity and mortality in schizophrenic patients. Currently, the efficacy of bupropion HCl in the treatment of smoking by schizophrenic subjects is inconclusive, and there have not been any published studies of the efficacy of varenicline in schizophrenic subjects. As varenicline appears to be a promising treatment in non-psychiatric patients, it would be useful to expand these studies to examine its effects in schizophrenic patients. Identifying effective and safe means of smoking cessation for this vulnerable population has the potential to reduce morbidity and mortality among individuals with schizophrenia.
Primary Outcome
Measured by blood/urine tests for nicotine and its break-down product cotinine.
Conditions Studied
Interventions
- DRUG Varenicline
- OTHER Sugar Pill
- DRUG Bupropion HCl
Study Locations (1)
Minnesota
- University of Minnesota, University of Minnesota Medical Center - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-12 |
| Est. Completion | 2012-08 |
| Phase | Phase 2 |
What the finished NCT01111149 record still lists
NCT01111149 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (89% lower).
The record links to 2 conditions, with Schizophrenia appearing as the primary indexed condition, and to 3 interventions - of which Varenicline is the first listed.
NCT01111149 reports a single indexed study location in Minnesota.
Frequently Asked Questions
What is clinical trial NCT01111149 about?
NCT01111149 is a clinical study titled "Varenicline and Smoking Cessation in Schizophrenia". There is a strong association between smoking and schizophrenia with prevalence rates ranging from 74% to 90%, versus a national average of 30% in nonschizophrenic individuals. A number of hypotheses have been proposed to explain the relationship between high smoking rates and schizophrenia, mostly ...
What is the current status of trial NCT01111149?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2009-12. Estimated completion is 2012-08.
What conditions does trial NCT01111149 study?
This clinical trial studies the following conditions: Schizophrenia, Smoking Cessation.
What interventions are being tested in trial NCT01111149?
The interventions under investigation include: Varenicline (DRUG), Sugar Pill (OTHER), Bupropion HCl (DRUG).
Who is sponsoring clinical trial NCT01111149?
This trial is sponsored by University of Minnesota, which has 966 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01111149 being conducted?
This trial has 1 study location across Minnesota. 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 NCT01111149's enrollment target sits among peer trials
24 276th of 315 higher than 36 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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