Phase 3
N=750
Disease Management for Smoking Cessation
Smoking Cessation
Bottom Line
View on ClinicalTrials.gov: NCT00440115 ↗Enrolled (actual)
750
Serious AEs
2.5%
Results posted
Jun 2017
Primary outcome: Primary: 7-day Point Prevalence Abstinence From Cigarettes — 68; 56; 56 Participants — p=0.54
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- High intensity disease management (Behavioral); Low intensity disease management (Behavioral); Comparison group (Behavioral); Bupropion (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 7-day Point Prevalence Abstinence From Cigarettes |
68; 56; 56 | 0.54 |
| SECONDARY Number of Quit Attempts |
171; 160; 142; 2; 4; 3 | — |
| SECONDARY Progress in Stage of Change |
24; 25; 15; 65; 74; 89 | — |
Summary
The primary aim of this study is to assess the effectiveness of both high and low intensity, disease management programs for smoking. The hypotheses are to compare abstinence from cigarettes, the number of quit attempts, and smokers motivation at 24 months between participants receiving high and low intensity disease management and those receiving usual care.
Eligibility Criteria
Inclusion Criteria
- Over the age of 18
- Reported smoking at least 10 cigarettes per day for at least 25 of the last 30 days
- Speak English
- Their regular physician is a participating physician
- Working home telephone or cellular phone
Exclusion Criteria
- Women who are pregnant or planning to become pregnant in the next two years
- Plan on moving within two years
- Display signs of dementia or other mental disorders
- Live with a smoker already enrolled
Data sourced from ClinicalTrials.gov (NCT00440115). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.