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

Primary Purpose

Tobacco Addiction

Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Extended Duration Behavioral Smoking Cessation Counseling
Sponsored by
Harvard University Faculty of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Addiction

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Harvard School of Dental MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Brief-Duration Counseling

Moderate Duration Counseling

Extended Duration Counseling

Arm Description

3-Month Duration

6-Month Duration

12-Month Duration

Outcomes

Primary Outcome Measures

Proportion of subjects abstinent by treatment group at 1 year post-cessation.

Secondary Outcome Measures

Proportion of subjects abstinent by treatment group at 2 years post-cessation.

Full Information

First Posted
December 22, 2009
Last Updated
June 22, 2011
Sponsor
Harvard University Faculty of Medicine
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01038414
Brief Title
Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence
Acronym
EDC
Official Title
Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence
Study Type
Interventional

2. Study Status

Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2008 (undefined)
Primary Completion Date
January 2013 (Anticipated)
Study Completion Date
January 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Harvard University Faculty of Medicine
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Addiction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Brief-Duration Counseling
Arm Type
Placebo Comparator
Arm Description
3-Month Duration
Arm Title
Moderate Duration Counseling
Arm Type
Active Comparator
Arm Description
6-Month Duration
Arm Title
Extended Duration Counseling
Arm Type
Active Comparator
Arm Description
12-Month Duration
Intervention Type
Behavioral
Intervention Name(s)
Extended Duration Behavioral Smoking Cessation Counseling
Other Intervention Name(s)
Extended-Duration Behvioral Smoking-Cessation Counseling
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of subjects abstinent by treatment group at 1 year post-cessation.
Time Frame
One year
Secondary Outcome Measure Information:
Title
Proportion of subjects abstinent by treatment group at 2 years post-cessation.
Time Frame
Two years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Harvard School of Dental Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arthur J Garvey, PhD
Phone
617-523-8558
Email
arthur_garvey@hms.harvard.edu
First Name & Middle Initial & Last Name & Degree
Arthur J Garvey, Ph.D.

12. IPD Sharing Statement

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Duration of Behavioral Counseling Treatment Needed to Optimize Smoking Abstinence

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