Tobacco Addiction
Conditions
Brief summary
The purpose of this study is to determine if extending the behavioral smoking-cessation treatment period to one year will significantly improve cessation outcomes among those planning a quit attempt.
Interventions
BEHAVIORALExtended Duration Behavioral Smoking Cessation Counseling
Subjects are randomized to one of 3 behavioral treatments: (1) Brief Duration (3 month) smoking-cessation counseling; (2) Moderate Duration (6 month) counseling; or (3) Extended Duration (12 month) counseling
Sponsors
National Institute on Drug Abuse (NIDA)
Harvard University Faculty of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Daily Cigarette Smokers
Exclusion criteria
* Smokers with active atherosclerotic heart disease, severe cardiac arrhythmias, uncontrolled hypertension, severe peripheral vascular disease, pre-controlled diabetes mellitus, pregnancy, lactation or likely to become pregnant during the study period, and chronic dermatologic disease. * Smokers who meet DSM-IV lifetime criteria for conditions such as schizo-affective disorder and schizophrenia, bi-polar disorder, or who have had alcohol or drug dependence issues within the past year.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects abstinent by treatment group at 1 year post-cessation. | One year |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects abstinent by treatment group at 2 years post-cessation. | Two years |
Countries
United States
Outcome results
None listed