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NCT01010477 · ClinicalTrials.gov registry record · Phase 4
Trial of Nicotine Nasal Spray as an Aid for Smoking Cessation in Schizophrenia
A Phase 4 study, sponsored by Rutgers, The State University of New Jersey.
- Completed
- Registry status
- Phase 4
- Development phase
- 66
- Enrollment target
NCT01010477: Completed Phase 4 study, sponsored by Rutgers, The State University of New Jersey.
NCT01010477 is a Phase 4 study that has completed, run by Rutgers, The State University of New Jersey. The registered enrollment target is 66 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01010477, a Phase 4 study, has completed, sponsored by Rutgers, The State University of New Jersey.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 66 participants
- Enrollment target
Study Summary
This R01 grant describes a randomized, double-blind, placebo-controlled trial of nicotine nasal spray (NNS) as an aid for smoking cessation in 60 individuals with schizophrenia. The objectives of this study are to determine the efficacy of NNS with behavioral intervention for smoking cessation in smokers with schizophrenia. It is hypothesized that the quit rate of subjects who receive NNS and behavioral intervention will be significantly greater than the quit rate of the control group who will receive the placebo spray plus same behavioral intervention. Quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million during these 4 weeks. The investigators will also assess abstinence rates at Study Weeks 12 and 20 on the NNS and at weeks 26 and 52 after the medication has been stopped. Since studies of this group suggest high relapse rates when treatments are discontinued (Evins et al., 2005; George et al., 2000; George et al., 2002a), the investigators will continue NNS treatment for a total of 20 weeks.
Primary Outcome
Quit rate is defined as the proportion of individuals who self report no tobacco use during weeks 5 through 8 confirmed by exhaled carbon monoxide (CO) less than 10 parts per million (ppm) during these 4 weeks.
Interventions
- BEHAVIORAL Behavioral counseling
- DRUG Nicotine Nasal Spray
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2009-08 |
| Est. Completion | 2012-08 |
| Phase | Phase 4 |
What the finished NCT01010477 record still lists
NCT01010477 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (87% lower).
The record links to 0 conditions, and to 2 interventions - of which Behavioral counseling is the first listed.
NCT01010477 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01010477 about?
NCT01010477 is a clinical study titled "Trial of Nicotine Nasal Spray as an Aid for Smoking Cessation in Schizophrenia". This R01 grant describes a randomized, double-blind, placebo-controlled trial of nicotine nasal spray (NNS) as an aid for smoking cessation in 60 individuals with schizophrenia. The objectives of this study are to determine the efficacy of NNS with behavioral intervention for smoking cessation in sm...
What is the current status of trial NCT01010477?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 66 participants. The study started on 2009-08. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01010477?
The interventions under investigation include: Behavioral counseling (BEHAVIORAL), Nicotine Nasal Spray (DRUG).
Who is sponsoring clinical trial NCT01010477?
This trial is sponsored by Rutgers, The State University of New Jersey, which has 413 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01010477's enrollment target sits among peer trials
66 1083rd of 2000 higher than 910 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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