Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence

Phase 4

• Conditions: Tobacco Addiction

• Registration Number: NCT01038414
• Lead Sponsor: Harvard University Faculty of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2009-12-22
• Study First Submitted QC: 2009-12-23
• Study First Posted: 2009-12-24
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-22
• Last Update Posted: 2011-06-23
• Primary Completion: 2013-01
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of subjects abstinent by treatment group at 1 year post-cessation.	One year

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects abstinent by treatment group at 2 years post-cessation.	Two years

Trial Locations

Locations (1)

Harvard School of Dental Medicine; 🇺🇸 Boston, Massachusetts, United States