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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: Completed Phase 4 study, sponsored by University of Wisconsin, Madison.
NCT02564315 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 1,154 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (123% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Participants who self-report no smoking for the past 7 days at the assessment endpoint (14 months post-randomization to Phase 2 Preparation treatment) and who provide an exhaled breath sample for carbon monoxide testing with a concentration no higher than 5 parts per million will be considered to meet criteria for Biochemically-confirmed 7-Day Point Prevalence Abstinence. Participants who do not meet these criteria will be considered to be relapsed (smoking).
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 |
What the finished NCT02564315 record still lists
NCT02564315 is an interventional study that assigns participants to a tested intervention. Its 1,154 participants enrollment target places it among the larger protocols in the corpus, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (123% higher).
The record links to 0 conditions, and to 5 interventions - of which Nicotine Mini-Lozenge for 11 Months is the first listed.
NCT02564315 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02564315's enrollment target sits among peer trials
1,154 63rd of 2000 higher than 1,938 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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