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NCT01783912 · ClinicalTrials.gov registry record · Phase 4
Helping Those With Mental Illness Quit Smoking
A Phase 4 study, sponsored by University of Wisconsin, Madison.
- Completed
- Registry status
- Phase 4
- Development phase
- 270
- Enrollment target
NCT01783912: Completed Phase 4 study, sponsored by University of Wisconsin, Madison.
NCT01783912 is a Phase 4 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 270 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (48% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01783912, a Phase 4 study, has completed, sponsored by University of Wisconsin, Madison.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 270 participants
- Enrollment target
Study Summary
This study tests whether pre-cessation interventions known to be effective in the general population will increase acceptance of evidence-based treatment, engagement and compliance with that treatment and initial quitting success. One hundred and seventy two patients will be recruited from 13 Community Support Programs (CSPs). CSPs provide community based care to those diagnosed with persistent and serious mental illness. All participants will receive two group sessions (40 minutes each) modeled after "Kicking Butts", a group-based quitting preparation program used for the past four years in two Milwaukee CSP programs run by Wisconsin Community Services. Individuals will then be randomly assigned to the experimental and control conditions (n=86 each). Experimental subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each). Attention control subjects will also receive four individual sessions of the same duration. However their individual sessions' content will be a discussion of the personal relevance of the group material and will not include any of the preparatory interventions. Data will be collected via brief surveys taken pre-intervention, at the end of the last individual session, and three months later and from a database provided by the Wisconsin Tobacco Quit Line (WTQL).
Primary Outcome
The primary outcome is participant acceptance of evidence based treatment through the WTQL at the end of the last individual session.
Interventions
- DRUG Nicotine Patch
- BEHAVIORAL Cognitive / Motivational Individual Sessions
- BEHAVIORAL Attention Control Individual Sessions
- BEHAVIORAL Group Curriculum
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 270 participants |
| Start Date | 2012-12 |
| Est. Completion | 2014-06 |
| Phase | Phase 4 |
What the finished NCT01783912 record still lists
NCT01783912 is an interventional study that assigns participants to a tested intervention. The registered 270 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (48% lower).
The record links to 0 conditions, and to 4 interventions - of which Nicotine Patch is the first listed.
NCT01783912 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01783912 about?
NCT01783912 is a clinical study titled "Helping Those With Mental Illness Quit Smoking". This study tests whether pre-cessation interventions known to be effective in the general population will increase acceptance of evidence-based treatment, engagement and compliance with that treatment and initial quitting success. One hundred and seventy two patients will be recruited from 13 Commun...
What is the current status of trial NCT01783912?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 270 participants. The study started on 2012-12. Estimated completion is 2014-06.
What interventions are being tested in trial NCT01783912?
The interventions under investigation include: Nicotine Patch (DRUG), Cognitive / Motivational Individual Sessions (BEHAVIORAL), Attention Control Individual Sessions (BEHAVIORAL), Group Curriculum (BEHAVIORAL).
Who is sponsoring clinical trial NCT01783912?
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 NCT01783912's enrollment target sits among peer trials
270 318th of 2000 higher than 1,682 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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