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Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence (EDC)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Harvard University Faculty of Medicine.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
National Institute on Drug Abuse (NIDA)
Information provided by:
Harvard University Faculty of Medicine
ClinicalTrials.gov Identifier:
NCT01038414
First received: December 22, 2009
Last updated: June 22, 2011
Last verified: June 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Tobacco Addiction
 Behavioral: Extended Duration Behavioral Smoking Cessation Counseling
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Harvard University Faculty of Medicine:

Primary Outcome Measures:
  • Proportion of subjects abstinent by treatment group at 1 year post-cessation. [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects abstinent by treatment group at 2 years post-cessation. [ Time Frame: Two years ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: February 2008
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Brief-Duration Counseling
3-Month Duration
 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
Other Name: Extended-Duration Behvioral Smoking-Cessation Counseling
Active Comparator: Moderate Duration Counseling
6-Month Duration
 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
Other Name: Extended-Duration Behvioral Smoking-Cessation Counseling
Active Comparator: Extended Duration Counseling
12-Month Duration
 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
Other Name: Extended-Duration Behvioral Smoking-Cessation Counseling

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01038414

Locations
United States, Massachusetts
Harvard School of Dental Medicine Recruiting
Boston, Massachusetts, United States, 02115
Contact: Arthur J Garvey, PhD     617-523-8558     arthur_garvey@hms.harvard.edu    
Principal Investigator: Arthur J Garvey, Ph.D.            
Sponsors and Collaborators
Harvard University Faculty of Medicine
National Institute on Drug Abuse (NIDA)
  More Information

No publications provided

Responsible Party: Arthur J. Garvey, Ph.D., Harvard School of Dental Medicine
ClinicalTrials.gov Identifier: NCT01038414     History of Changes
Other Study ID Numbers: 5R01DA12165-8, 5R01DA012165
Study First Received: December 22, 2009
Last Updated: June 22, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Behavior, Addictive
Compulsive Behavior
Impulsive Behavior

ClinicalTrials.gov processed this record on June 13, 2013