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NCT01116986 · ClinicalTrials.gov registry record · Phase 4
Identifying Optimal Smoking Cessation Intervention Components (Cessation)
A Phase 4 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 4
- Development phase
- 637
- Enrollment target
NCT01116986: Completed Phase 4 study, sponsored by University of Wisconsin, Madison.
NCT01116986 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 637 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (23% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01116986, a Phase 4 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 637 participants
- Enrollment target
Study Summary
The goal of this research is to identify the best smoking cessation intervention components to be combined into a state-on-the-art, comprehensive smoking cessation intervention. This research examines the ability of different interventions, provided both prior to and after the quit attempt, to maximize the ability to initially quit and then stay quit. The investigators will be examining six different treatment interventions: pre-quit nicotine patch, pre-quit nicotine gum, pre-quit counseling, post-quit in-person counseling, post-quit phone counseling and duration of post-quit nicotine replacement therapy.
Primary Outcome
Self-Reported 7-Day Point-Prevalence Abstinence is a dichotomous outcome with values of 0 and 1 where 0=smoking on one or more of the past 7 days at the assessment endpoint (16 weeks post-quit) and 1=no smoking on any of the past 7 days at the assessment endpoint (i.e., abstinent for the past 7 days); this outcome will be analyzed in a logistic regression analysis model. Note: This abstinence primary outcome replaces latency to relapse (now designated as a secondary outcome) because reviewers o
Interventions
- BEHAVIORAL Counseling before quit attempt
- BEHAVIORAL Minimal In-person counseling during quit attempt
- BEHAVIORAL Intensive in-person counseling during the quit attempt
- BEHAVIORAL Minimal phone counseling during the quit attempt
- BEHAVIORAL Intensive phone counseling during the quit attempt
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 637 participants |
| Start Date | 2010-06 |
| Est. Completion | 2014-05 |
| Phase | Phase 4 |
What the finished NCT01116986 record still lists
NCT01116986 is an interventional study that assigns participants to a tested intervention. The registered 637 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (23% higher).
The record links to 0 conditions, and to 5 interventions - of which Counseling before quit attempt is the first listed.
NCT01116986 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01116986 about?
NCT01116986 is a clinical study titled "Identifying Optimal Smoking Cessation Intervention Components (Cessation)". The goal of this research is to identify the best smoking cessation intervention components to be combined into a state-on-the-art, comprehensive smoking cessation intervention. This research examines the ability of different interventions, provided both prior to and after the quit attempt, to maxim...
What is the current status of trial NCT01116986?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 637 participants. The study started on 2010-06. Estimated completion is 2014-05.
What interventions are being tested in trial NCT01116986?
The interventions under investigation include: Counseling before quit attempt (BEHAVIORAL), Minimal In-person counseling during quit attempt (BEHAVIORAL), Intensive in-person counseling during the quit attempt (BEHAVIORAL), Minimal phone counseling during the quit attempt (BEHAVIORAL), Intensive phone counseling during the quit attempt (BEHAVIORAL).
Who is sponsoring clinical trial NCT01116986?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01116986's enrollment target sits among peer trials
637 127th of 2000 higher than 1,874 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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