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NCT01027754 · ClinicalTrials.gov registry record · Phase 4
Smoking Cessation Treatment for Methadone Maintenance Patients
A Phase 4 study, sponsored by Albert Einstein College of Medicine.
- Completed
- Registry status
- Phase 4
- Development phase
- 112
- Enrollment target
NCT01027754: Completed Phase 4 study, sponsored by Albert Einstein College of Medicine.
NCT01027754 is a Phase 4 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 112 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01027754, a Phase 4 study, has completed, sponsored by Albert Einstein College of Medicine.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 112 participants
- Enrollment target
Study Summary
Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for patients in substance abuse treatment. The drug varenicline (Chantix) has been shown to be more effective at helping people quit smoking than nicotine replacement therapy, bupropion or placebo. However, varenicline has not yet been studied in patients in substance abuse treatment. The study aims to evaluate the feasibility, effectiveness and safety of varenicline, in combination with counseling, in methadone maintained smokers. It also aims to evaluate the link between quitting smoking and alcohol and illicit drug use in methadone maintained smokers. We hypothesize that participants receiving varenicline will have higher abstinence from smoking than participants receiving placebo and that participants taking varenicline will not have significantly more adverse reactions than were described in the general population in other studies. We also hypothesize that compared to continued smokers, tobacco abstainers will be more likely to be abstinent from alcohol or illicit drugs.
Interventions
- DRUG Placebo
- DRUG Varenicline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2009-08 |
| Est. Completion | 2011-09 |
| Phase | Phase 4 |
What the finished NCT01027754 record still lists
NCT01027754 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (78% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01027754 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01027754 about?
NCT01027754 is a clinical study titled "Smoking Cessation Treatment for Methadone Maintenance Patients". Patients in substance abuse treatment smoke four times more than non-substance abusers, and suffer high rates of tobacco-related disease and death. While many quit smoking treatments exist that have been shown to help non-substance abusers quit smoking, little is known about what treatments work for...
What is the current status of trial NCT01027754?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 112 participants. The study started on 2009-08. Estimated completion is 2011-09.
What interventions are being tested in trial NCT01027754?
The interventions under investigation include: Placebo (DRUG), Varenicline (DRUG).
Who is sponsoring clinical trial NCT01027754?
This trial is sponsored by Albert Einstein College of Medicine, which has 175 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01027754's enrollment target sits among peer trials
112 724th of 2000 higher than 1,275 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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