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NCT00178685 · ClinicalTrials.gov registry record · Phase 4
Smokers' Health Project: Self-Determination and Maintaining Tobacco Abstinence
A Phase 4 study of Tobacco Use Disorder, sponsored by University of Rochester.
- Completed
- Registry status
- Phase 4
- Development phase
- 837
- Enrollment target
- 1
- Study location
NCT00178685: Completed Phase 4 study of Tobacco Use Disorder, sponsored by University of Rochester.
NCT00178685 is a Phase 4 study of Tobacco Use Disorder that has completed, run by University of Rochester. The registered enrollment target is 837 participants, above the 227-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (269% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00178685, a Phase 4 study of Tobacco Use Disorder, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 837 participants
- Enrollment target
- 1
- Study location
Study Summary
These two studies will examine the role of autonomous motivation in maintained adherence. The first study will determine whether smokers are still abstinent from tobacco 32 months after starting in a previous project (Smoker's Health Study). The purpose of the second study is to determine which of three treatments for tobacco dependence provides the greatest amount of protection from relapsing to smoking after quitting. Specifically, the investigators will determine if extending the length of treatment time focusing on relapse prevention and arranging for support from important others prevents relapse compared to community care. Also, the investigators will determine if providing extended treatment time and support from important others plus providing medications to those that don't want to quit prevents long term relapse compared to just extending the length of treatment time and support from others. Additionally, a sub set of the population will be randomized to using hand held palm devices to recover real-time data assessment during the last 10 months of the project.
Primary Outcome
The primary outcome measure was 12-month prolonged abstinence (12M-PA) assessed by patient self-report 12-months after the intervention ended. If participant responded that they had not smoked a cigarette, even a puff, in the last 7 days at 12 months post-intervention, and reported date of last cigarette was 365 days or more prior to assessment date, then they were considered to have 12 month prolonged abstinence. A baseline-observation-carried-forward (BOCF)strategy was used for missing data su
Conditions Studied
Interventions
- BEHAVIORAL Self-determination Intervention for Tobacco Dependence
Study Locations (1)
New York
- Smokers' Health Project - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 837 participants |
| Start Date | 2004-08 |
| Est. Completion | 2008-08 |
| Phase | Phase 4 |
What the finished NCT00178685 record still lists
NCT00178685 is an interventional study that assigns participants to a tested intervention. The registered 837 participants enrollment target is mid-sized for trials with a published cap, above the 227-participant average among 70 other Tobacco Use Disorder trials with a reported enrollment target (269% higher).
The record links to 1 condition, with Tobacco Use Disorder appearing as the primary indexed condition, and to 1 intervention - of which Self-determination Intervention for Tobacco Dependence is the first listed.
NCT00178685 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00178685 about?
NCT00178685 is a clinical study titled "Smokers' Health Project: Self-Determination and Maintaining Tobacco Abstinence". These two studies will examine the role of autonomous motivation in maintained adherence. The first study will determine whether smokers are still abstinent from tobacco 32 months after starting in a previous project (Smoker's Health Study). The purpose of the second study is to determine which of t...
What is the current status of trial NCT00178685?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 837 participants. The study started on 2004-08. Estimated completion is 2008-08.
What conditions does trial NCT00178685 study?
This clinical trial studies the following conditions: Tobacco Use Disorder.
What interventions are being tested in trial NCT00178685?
The interventions under investigation include: Self-determination Intervention for Tobacco Dependence (BEHAVIORAL).
Who is sponsoring clinical trial NCT00178685?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00178685 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Tobacco Use Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00178685's enrollment target sits among peer trials
837 5th of 70 higher than 66 of 70 other Tobacco Use Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Tobacco Use Disorder 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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