Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence

Tobacco Addiction Clinical Trial

— EDC  

Official title:

Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01038414
• Other study ID #: 5R01DA12165-8
• Secondary ID: 5R01DA012165
• Status: Recruiting
• Phase: Phase 4
• First received: December 22, 2009
• Last updated: June 22, 2011
• Start date: February 2008
• Est. completion date: January 2013

Study information

• Verified date: June 2011
• Source: Harvard University Faculty of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Addiction

Intervention

Behavioral:
• Extended 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

Locations

Country	Name	City	State
United States	Harvard School of Dental Medicine	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Harvard University Faculty of Medicine	National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects abstinent by treatment group at 1 year post-cessation.		One year	No
Secondary	Proportion of subjects abstinent by treatment group at 2 years post-cessation.		Two years	No