NCT01038414

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2008

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 22, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 24, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

June 23, 2011

Status Verified

June 1, 2011

Enrollment Period

4.9 years

First QC Date

December 22, 2009

Last Update Submit

June 22, 2011

Conditions

Tobacco Addiction

Outcome Measures

Primary Outcomes (1)

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

    One year

Secondary Outcomes (1)

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

    Two years

Study Arms (3)

Brief-Duration Counseling

PLACEBO COMPARATOR

3-Month Duration

Behavioral: Extended Duration Behavioral Smoking Cessation Counseling

Moderate Duration Counseling

ACTIVE COMPARATOR

6-Month Duration

Behavioral: Extended Duration Behavioral Smoking Cessation Counseling

Extended Duration Counseling

ACTIVE COMPARATOR

12-Month Duration

Behavioral: Extended Duration Behavioral Smoking Cessation Counseling

Interventions

Extended Duration Behavioral Smoking Cessation CounselingBEHAVIORAL

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

Also known as: Extended-Duration Behvioral Smoking-Cessation Counseling
Brief-Duration CounselingExtended Duration CounselingModerate Duration Counseling

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Daily Cigarette Smokers

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Harvard School of Dental Medicine

Boston, Massachusetts, 02115, United States

RECRUITING

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 22, 2009

First Posted

December 24, 2009

Study Start

February 1, 2008

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

June 23, 2011

Record last verified: 2011-06

Locations

US(1)