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NCT01065506 · ClinicalTrials.gov registry record · Phase 3
Smoking Termination Enhancement Project (STEP)
A Phase 3 study, sponsored by Southern Methodist University.
- Completed
- Registry status
- Phase 3
- Development phase
- 150
- Enrollment target
NCT01065506: Completed Phase 3 study, sponsored by Southern Methodist University.
NCT01065506 is a Phase 3 study that has completed, run by Southern Methodist University. The registered enrollment target is 150 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01065506, a Phase 3 study, has completed, sponsored by Southern Methodist University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 150 participants
- Enrollment target
Study Summary
The primary aim of this research study (STEP) is to compare the effectiveness of two smoking cessation programs that integrate counseling and nicotine replacement with either a wellness program or exercise. This will help us to determine whether different lifestyle interventions (wellness or exercise) help increase the effectiveness of current standard programs for smoking cessation.
Primary Outcome
Point Prevalence Abstinence (PPA) was defined as not smoking \[even a single puff\] at the end of treatment and/or on the day of follow-up
Interventions
- BEHAVIORAL Aerobic Exercise
- BEHAVIORAL Wellness Program
- DRUG Nicotine Patch
- BEHAVIORAL Cognitive Behavioral Treatment
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2009-09 |
| Est. Completion | 2013-08 |
| Phase | Phase 3 |
What the finished NCT01065506 record still lists
NCT01065506 is an interventional study that assigns participants to a tested intervention. The registered 150 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (81% lower).
The record links to 0 conditions, and to 4 interventions - of which Aerobic Exercise is the first listed.
NCT01065506 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01065506 about?
NCT01065506 is a clinical study titled "Smoking Termination Enhancement Project (STEP)". The primary aim of this research study (STEP) is to compare the effectiveness of two smoking cessation programs that integrate counseling and nicotine replacement with either a wellness program or exercise. This will help us to determine whether different lifestyle interventions (wellness or exercis...
What is the current status of trial NCT01065506?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 150 participants. The study started on 2009-09. Estimated completion is 2013-08.
What interventions are being tested in trial NCT01065506?
The interventions under investigation include: Aerobic Exercise (BEHAVIORAL), Wellness Program (BEHAVIORAL), Nicotine Patch (DRUG), Cognitive Behavioral Treatment (BEHAVIORAL).
Who is sponsoring clinical trial NCT01065506?
This trial is sponsored by Southern Methodist University, which has 17 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01065506's enrollment target sits among peer trials
150 1519th of 2000 higher than 455 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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