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NCT01576640 · ClinicalTrials.gov registry record · Phase 4
Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia
A Phase 4 study, sponsored by Massachusetts General Hospital.
- Terminated
- Registry status
- Phase 4
- Development phase
- 17
- Enrollment target
NCT01576640: Clinical Trial Phase 4 study, sponsored by Massachusetts General Hospital.
NCT01576640 is a Phase 4 study that was terminated before completion, run by Massachusetts General Hospital. The registered enrollment target is 17 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01576640, a Phase 4 study, was terminated before completion, sponsored by Massachusetts General Hospital.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 17 participants
- Enrollment target
Study Summary
After successfully quitting smoking, smokers with schizophrenia are vulnerable to relapse shortly after discontinuation of treatment. The purpose of this study was to assess the feasibility and effectiveness of a 12-month relapse prevention intervention in recently abstinent smokers with schizophrenia. Subjects participated in a 12-week smoking cessation phase, where they received nicotine replacement therapy, bupropion SR 150mg bid, and cognitive behavioral therapy. If, at the end of the 12 weeks, they were able to demonstrate 1 week of abstinence, they continued in the relapse prevention phase of the study, where they continued to receive nicotine replacement therapy, bupropion SR 150mg bid, and cognitive behavioral therapy.
Interventions
- DRUG NRT
- DRUG Bupropion SR 150mg bid
- OTHER Relapse Prevention-Oriented Cognitive Behavioral Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2005-12 |
| Est. Completion | 2007-10 |
| Phase | Phase 4 |
Why NCT01576640 stopped before completion
NCT01576640 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 3 interventions - of which NRT is the first listed.
NCT01576640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01576640 about?
NCT01576640 is a clinical study titled "Extended Duration Nicotine Replacement Therapy and Bupropion in Smokers With Schizophrenia". After successfully quitting smoking, smokers with schizophrenia are vulnerable to relapse shortly after discontinuation of treatment. The purpose of this study was to assess the feasibility and effectiveness of a 12-month relapse prevention intervention in recently abstinent smokers with schizophren...
What is the current status of trial NCT01576640?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 17 participants. The study started on 2005-12. Estimated completion is 2007-10.
What interventions are being tested in trial NCT01576640?
The interventions under investigation include: NRT (DRUG), Bupropion SR 150mg bid (DRUG), Relapse Prevention-Oriented Cognitive Behavioral Therapy (OTHER).
Who is sponsoring clinical trial NCT01576640?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01576640's enrollment target sits among peer trials
17 1854th of 2000 higher than 132 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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