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NCT02564315 · ClinicalTrials.gov registry record · Phase 4
The Long-Term Quitting (Smoking Cessation) Study
A Phase 4 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 4
- Development phase
- 1,154
- Enrollment target
NCT02564315 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 1,154 participants.
The verdict
NCT02564315, a Phase 4 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 1,154 participants
- Enrollment target
Study Summary
Relapse after a serious quit attempt occurs in 70-90% of smokers who try to quit smoking. This study utilizes a sequential, multiple assignment, randomized trial (SMART) design - - an innovative multi-phase approach - - to test post-relapse treatments designed to assist smokers to make a new, successful quit attempt. This study will test Relapse Recovery (RR) treatments that are applied at two stages following relapse: 1) RR Preparation Phase treatments for smokers who relapse after an initial quit attempt, and 2) RR Cessation Phase treatments for relapsed smokers who decide to make a new quit attempt. Smokers motivated to quit smoking will make an initial quit attempt in the Quit Phase (cessation medication + counseling). Participants who relapse will be randomized to one of three RR Preparation Phase treatments (Behavioral \[Smoking\] Reduction Counseling + the Nicotine Mini-Lozenge; Recycling Counseling that encourages participants to quit again as soon as possible; and Preparation Phase Control). RR Preparation Phase participants (other than controls) who elect to try a new quit attempt will be randomized to one of four RR Cessation Phase treatments based on a 2X2 fully-crossed factorial design testing two factors: Supportive Counseling (vs. Brief Information) and Skill Training (vs. Brief Information). All RR Cessation Phase participants will receive 8 weeks of combination nicotine replacement therapy (nicotine patch + nicotine mini-lozenge). The investigators hypothesize that RR Preparation Phase Reduction treatment will significantly increase long-term abstinence rates relative to the Preparation Phase Control condition.
Interventions
- DRUG Nicotine Mini-Lozenge for 11 Months
- BEHAVIORAL Preparation Phase Behavioral Reduction Counseling
- BEHAVIORAL Preparation Phase Recycling Counseling
- BEHAVIORAL Preparation Phase Control Treatment
- BEHAVIORAL Cessation Phase Supportive Counseling
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,154 participants |
| Start Date | 2015-10-30 |
| Est. Completion | 2019-11-05 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02564315
The ClinicalTrials.gov registry entry for NCT02564315 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 1,154 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 5 interventions - of which Nicotine Mini-Lozenge for 11 Months is the first listed.
NCT02564315 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02564315 about?
NCT02564315 is a clinical study titled "The Long-Term Quitting (Smoking Cessation) Study". Relapse after a serious quit attempt occurs in 70-90% of smokers who try to quit smoking. This study utilizes a sequential, multiple assignment, randomized trial (SMART) design - - an innovative multi-phase approach - - to test post-relapse treatments designed to assist smokers to make a new, succes...
What is the current status of trial NCT02564315?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 1,154 participants. The study started on 2015-10-30. Estimated completion is 2019-11-05.
What interventions are being tested in trial NCT02564315?
The interventions under investigation include: Nicotine Mini-Lozenge for 11 Months (DRUG), Preparation Phase Behavioral Reduction Counseling (BEHAVIORAL), Preparation Phase Recycling Counseling (BEHAVIORAL), Preparation Phase Control Treatment (BEHAVIORAL), Cessation Phase Supportive Counseling (BEHAVIORAL).
Who is sponsoring clinical trial NCT02564315?
This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.
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