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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 is a Phase 4 study that has completed, run by Albert Einstein College of Medicine. The registered enrollment target is 112 participants.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01027754
The ClinicalTrials.gov registry entry for NCT01027754 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Albert Einstein College of Medicine, which has 175 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01027754 reports 0 study locations.
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.
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