NCT00683839

Brief Summary

The study will examine the effectiveness of public health dental practitioners using a brief office based intervention designed to help patients quit smoking or smokeless tobacco use, as compared to usual care.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,637

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2006

Typical duration for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 26, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

October 26, 2011

Status Verified

October 1, 2011

Enrollment Period

3.7 years

First QC Date

May 16, 2008

Last Update Submit

October 24, 2011

Conditions

Smoking

Keywords

TobaccoSmokingSmokelessCessationPublic health clinicDental patients5 AsNRTTobacco Quit LineSmokeless tobacco

Outcome Measures

Primary Outcomes (1)

  • The primary outcome is prolonged abstinence at 7.5 months following intervention.

    7.5 months

Secondary Outcomes (3)

  • Reduction in tobacco use at 6 weeks and 7.5 months following intervention.

    6 weeks and 7.5 months

  • Number of quit attempts at 6 weeks and 7.5 months following intervention.

    6 weeks & 7.5 months

  • Increase in readiness to quit at 6 weeks & 7.5 months following intervention.

    6 weeks & 7.5 months

Study Arms (2)

2

EXPERIMENTAL

Dental practitioners provide the following intervention: 5As plus nicotine replacement therapy The 5As consist of: Ask, Advise, Assess, Assist and Arrange.

Behavioral: Brief tobacco counseling

1

NO INTERVENTION

Usual Care Control: Patients receive treatment as usual.

Interventions

Brief tobacco counselingBEHAVIORAL

Public health dental professionals provide brief counseling during routine visits based on the Clinical Practice Guidelines 5 As (Ask, Advise, Assess, Assist, Arrange), including offering free Nicotine Replacement Therapy and referral to a Tobacco Quit Line. Pharmacologic: nicotine patch or lozenge maximum 12 week course.

2

Eligibility Criteria

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

You may qualify if:

  • Patients of participating public health dental clinics
  • Tobacco users

You may not qualify if:

  • Emergency patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Mississippi

Jackson, Mississippi, 39213, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Related Publications (4)

  • Hinds E, Gordon JS, Widdop CJ. Tobacco Cessation in Public Health Dental Clinics: Short-Term Outcomes for Women. Society of Behavioral Medicine's 29th Annual Meeting and Scientific Sessions in San Diego, California, March 26-29th, 2008.

    BACKGROUND

  • Gordon JS, Andrews JA, Albert DA, Crews KM, Payne TJ, Severson HH. Tobacco cessation via public dental clinics: results of a randomized trial. Am J Public Health. 2010 Jul;100(7):1307-12. doi: 10.2105/AJPH.2009.181214. Epub 2010 May 13.

    PMID: 20466951RESULT

  • Theodoulou A, Fanshawe TR, Leavens E, Theodoulou E, Wu AD, Heath L, Stewart C, Nollen N, Ahluwalia JS, Butler AR, Hajizadeh A, Thomas J, Lindson N, Hartmann-Boyce J. Differences in the effectiveness of individual-level smoking cessation interventions by socioeconomic status. Cochrane Database Syst Rev. 2025 Jan 27;1(1):CD015120. doi: 10.1002/14651858.CD015120.pub2.

    PMID: 39868569DERIVED

  • Holliday R, Hong B, McColl E, Livingstone-Banks J, Preshaw PM. Interventions for tobacco cessation delivered by dental professionals. Cochrane Database Syst Rev. 2021 Feb 19;2(2):CD005084. doi: 10.1002/14651858.CD005084.pub4.

    PMID: 33605440DERIVED

MeSH Terms

Conditions

SmokingTobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Judith S. Gordon, Ph.D

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 26, 2008

Study Start

January 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

October 26, 2011

Record last verified: 2011-10

Locations

US(3)