Phase 4
N=820
Smokers' Health Project: Self-Determination and Maintaining Tobacco Abstinence
Tobacco Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00178685 ↗Enrolled (actual)
820
Serious AEs
1.6%
Results posted
Feb 2013
Primary outcome: Primary: 12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention. — 169; 321; 318 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Self-determination Intervention for Tobacco Dependence (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Rochester
- Primary completion
- Aug 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 12 Month Prolonged Abstinence From Tobacco Measured at 12 Months From Completion of Intervention. |
169; 321; 318 | — |
| SECONDARY 7 Day Point Prevelence (7DPP) |
169; 321; 318 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Smoking 5 or more cigarettes per day.
- 18 years of age or older.
- Speak and read English.
- Eligible regardless of desire to quit smoking
Exclusion Criteria
- Pregnancy
- History of psychotic illness other than depression
- Life expectancy of less than 24 months
- Dementia, or incompetence for medical decision making
Data sourced from ClinicalTrials.gov (NCT00178685). 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.