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NCT00549640 · ClinicalTrials.gov registry record · Phase 2
Testing Methylphenidate for Smoking Abstinence
A Phase 2 study, sponsored by Mayo Clinic.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT00549640: Completed Phase 2 study, sponsored by Mayo Clinic.
NCT00549640 is a Phase 2 study that has completed, run by Mayo Clinic. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00549640, a Phase 2 study, has completed, sponsored by Mayo Clinic.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
Cigarette smoking continues to be a major public health problem. Tobacco dependence interventions, as recommended by the USPHS Clinical Practice Guideline are not effective for all smokers. A need exists for new medications to treat various aspects of tobacco dependence, such as the reinforcing effects of nicotine, relief of nicotine withdrawal symptoms and prevention of early relapse. The neurobiology of the effect of methylphenidate is similar to that of the reinforcing effects of nicotine. In a small previous study, methylphenidate was reported to improve nicotine withdrawal symptoms and short term quit rates. Methylphenidate is well tolerated, has low abuse potential, and is less expensive compared to other tobacco dependence interventions. ConcertaTM, a long acting preparation of methylphenidate, is administered once a day, has similar bioavailability as the generic drug administered 3 times a day and has an overall similar or improved efficacy compared to generic methylphenidate. We plan to obtain preliminary efficacy data in a randomized, placebo-controlled phase II study assessing the effect of methylphenidate in cigarette smokers for increasing 7-day point prevalence smoking abstinence at end of treatment and 7-day point prevalence and prolonged smoking abstinence at 6-months. Critical and systematic evaluations of newer, innovative, and well-tolerated treatments to help treat tobacco use and dependence will provide a wider choice of therapeutic agents to smokers wishing to become abstinent from tobacco use.
Primary Outcome
Number of subject who self report no smoking in the last 7 days (7-day point prevalence)at the end of the medication phase (week 8) and are biochemically confirmed (expired carbon monoxide \<= 8 ppm)
Interventions
- DRUG Placebo
- DRUG Methylphenidate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2008-01 |
| Est. Completion | 2009-05 |
| Phase | Phase 2 |
What the finished NCT00549640 record still lists
NCT00549640 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00549640 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00549640 about?
NCT00549640 is a clinical study titled "Testing Methylphenidate for Smoking Abstinence". Cigarette smoking continues to be a major public health problem. Tobacco dependence interventions, as recommended by the USPHS Clinical Practice Guideline are not effective for all smokers. A need exists for new medications to treat various aspects of tobacco dependence, such as the reinforcing effe...
What is the current status of trial NCT00549640?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2008-01. Estimated completion is 2009-05.
What interventions are being tested in trial NCT00549640?
The interventions under investigation include: Placebo (DRUG), Methylphenidate (DRUG).
Who is sponsoring clinical trial NCT00549640?
This trial is sponsored by Mayo Clinic, which has 2,844 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00549640's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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