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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 is a Phase 2 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 232 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04969198
The ClinicalTrials.gov registry entry for NCT04969198 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 232 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
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 reports 0 study locations.
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.
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