Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence

Verified by: Harvard University Faculty of Medicine, June 2011
First Received: December 22, 2009 | Last Updated: June 22, 2011 | Phase: Phase 4 | Start Date: February 2008
Overall Status: Recruiting | Estimated Enrollment: 450
  • …
  • Tell a FriendPrint

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...

Brief Summary

Official Title: “Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
  • Study Primary Completion Date: January 2013

Intervention(s) in this Clinical Trial

  • 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

Arms, Groups and Cohorts in this Clinical Trial

  • Placebo Comparator: Brief-Duration Counseling
    • 3-Month Duration
  • Active Comparator: Moderate Duration Counseling
    • 6-Month Duration
  • Active Comparator: Extended Duration Counseling
    • 12-Month Duration

Outcome Measures for this Clinical Trial

Primary Measures

  • Proportion of subjects abstinent by treatment group at 1 year post-cessation.
    • Time Frame: One year
      Safety Issue?: No

Secondary Measures

  • Proportion of subjects abstinent by treatment group at 2 years post-cessation.
    • Time Frame: Two years
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Clinical Trial Investigator Information

Lead Investigator: Harvard University Faculty of Medicine Other

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT01038414

Study ID Number: 5R01DA12165-8

ClinicalTrials.gov Identifier: NCT01038414

Health Authority: United States: Institutional Review Board

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT01038414