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NCT04969198 · ClinicalTrials.gov registry record · Phase 2
UW Withdraw From Tobacco Study
A Phase 2 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 2
- Development phase
- 232
- Enrollment target
NCT04969198: Completed Phase 2 study, sponsored by University of Wisconsin, Madison.
NCT04969198 is a Phase 2 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 232 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04969198, a Phase 2 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 232 participants
- Enrollment target
Study Summary
It is of considerable scientific and clinical importance to assess tobacco withdrawal accurately since withdrawal severity is highly determinant of smoking cessation success. In addition, smoking cessation pharmacotherapy produces its effects on smoking abstinence by suppressing such symptoms. However, in order to ensure that a measure of tobacco withdrawal is sensitive to severe withdrawal, it is essential to examine a period of unmedicated abstinence. The current study aims to validate, and possibly enhance, a revised Wisconsin Smoking Withdrawal Scale long and brief version for use in research and clinical settings. Two hundred adults who smoke cigarettes daily and report a desire to quit smoking will be enrolled. This is a treatment-delay, one-group clinical trial that is intended to enhance the assessment of tobacco withdrawal amongst participants who try to quit smoking with delayed use of cessation medication. Participants will not receive any pharmacotherapy during the first 1 week of their quit attempt and will initiate 8 weeks of combination nicotine replacement therapy (C-NRT; nicotine patch + nicotine mini-lozenge) starting 1 week past the target quit day (TQD). Participants will receive 4 counseling sessions as well (1 pre-quit, 3 post-quit). Participants will complete 4 weeks of ecological momentary assessment (EMA) smartphone surveys including a 2-week baseline (starting TQD-14) and 2-week post-TQD (1-week un-medicated, 1-week using C-NRT).
Primary Outcome
Self-reported withdrawal symptom severity in the last 24 hours using the Wisconsin Smoking Withdrawal Scale 2(WSWS-2) Long Version. WSWS-2 consists of 19 items. Each item answers on a scale from 1=not at all to 7=extremely, how much a participant has been bothered in the last 24 hours. Mean score from 1-7 is reported. Higher scores indicate more severe withdrawal symptoms.
Interventions
- DRUG Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 232 participants |
| Start Date | 2021-07-13 |
| Est. Completion | 2022-09-21 |
| Phase | Phase 2 |
What the finished NCT04969198 record still lists
NCT04969198 is an interventional study that assigns participants to a tested intervention. The registered 232 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% higher).
The record links to 0 conditions, and to 1 intervention - of which Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge) is the first listed.
NCT04969198 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04969198 about?
NCT04969198 is a clinical study titled "UW Withdraw From Tobacco Study". It is of considerable scientific and clinical importance to assess tobacco withdrawal accurately since withdrawal severity is highly determinant of smoking cessation success. In addition, smoking cessation pharmacotherapy produces its effects on smoking abstinence by suppressing such symptoms. Howev...
What is the current status of trial NCT04969198?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 232 participants. The study started on 2021-07-13. Estimated completion is 2022-09-21.
What interventions are being tested in trial NCT04969198?
The interventions under investigation include: Combination nicotine replacement therapy (Nicotine patch + nicotine mini-lozenge) (DRUG).
Who is sponsoring clinical trial NCT04969198?
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 NCT04969198's enrollment target sits among peer trials
232 256th of 2000 higher than 1,744 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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