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Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00820495
Recruitment Status : Completed
First Posted : January 12, 2009
Last Update Posted : August 5, 2013
National Cancer Institute (NCI)
University of California, San Diego
Information provided by (Responsible Party):
Oregon Research Institute

Brief Summary:
The purpose of this record is to test whether (a) participants who receive a Web-based smokeless tobacco cessation intervention will be more likely to be abstinent than participants who do not receive this intervention, and (b) whether participants who receive a telephone quitline intervention will be more likely to be abstinent than participants who are not in a quitline intervention.

Condition or disease Intervention/treatment Phase
Tobacco Use Disorder Behavioral: Web + Phone Behavioral: Web Only Behavioral: Phone Only Behavioral: Usual Care Phase 2

Detailed Description:

Many Americans engage in the habitual use of smokeless tobacco (ST), and many wish to quit but lack resources. There is a need for innovative, validated, and easily delivered low-cost interventions to facilitate ST cessation in this under-served population of tobacco users. In our current ChewFree study, we have developed a user-friendly, interactive Web-based intervention, and in a randomized trial we have shown this website to be more efficacious than a rigorous control condition that offered Web-based basic textual information on ST cessation. We now seek to extend this proven approach by marrying it with a quitline telephone counseling service that has been used with noteworthy success for smoking abstinence but has not yet been evaluated with ST users. Our 2 x 2 design and large sample size allow us to test both main effects - Web program, phone counseling - as well as explore planned comparisons to examine the value-added contribution of the Web-based intervention to phone counseling, and vice-versa.

This project takes advantage of the opportunity to conduct a study of two tobacco cessation interventions that are growing in use. The use of tobacco help lines is now almost ubiquitous, with more than 30 state and national services now being offered. The use of the Internet for health information and behavior change (including tobacco cessation) has been growing in popularity as well. The proposed project would be an extension of both lines of research, evaluating the relative efficacy of our Internet-based program, telephone counseling, and the combination of both.

We will use a multifaceted promotional plan to recruit more than 2,000 ST users. The recruitment plan builds on the collaborative marketing efforts of a state tobacco control organization and organized promotion through media mailings, on-line advertising, and direct mailing. Follow-up assessment data will be collected electronically via the Internet supplemented by telephone follow-up. Additional data will be derived from phone counselor notes and measures of website usage.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1683 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users
Study Start Date : May 2009
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Web + Phone
Highly interactive tailored Web-based smokeless tobacco cessation program plus phone counseling
Behavioral: Web + Phone
Web + Phone
Other Names:
  • web-assisted intervention
  • quitline
  • helpline

Experimental: Web Only
Highly interactive tailored Web-based smokeless tobacco cessation program
Behavioral: Web Only
Web Only
Other Name: web-assisted intervention

Experimental: Phone Only
Phone counseling intervention for smokeless tobacco cessation
Behavioral: Phone Only
Phone Only
Other Names:
  • helpline
  • quitline

Experimental: Control
Usual care (initial call plus self-help materials)
Behavioral: Usual Care
Usual Care
Other Names:
  • helpline
  • quitline

Primary Outcome Measures :
  1. Prolonged abstinence from all tobacco [ Time Frame: 3 months and 6 months ]

Secondary Outcome Measures :
  1. 7-day point prevalence for smokeless tobacco use [ Time Frame: 3 months and 6 months ]
  2. 7-day point prevalence for all tobacco use [ Time Frame: 3 months and 6 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • current users of smokeless tobacco products (snuff or chewing tobacco)
  • use of smokeless tobacco products for at least 1 year
  • use of at least one tin or pouch per week
  • interest in quitting all tobacco
  • U.S. resident 18 years of age or older
  • ability to read English
  • willingness to share a phone number, e-mail, and mailing address
  • use of personal Internet e-mail account at least once per week
  • informed consent

Exclusion criteria:

  • none

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00820495

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United States, California
University of California, San Diego
San Diego, California, United States, 92111
United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Oregon Research Institute
National Cancer Institute (NCI)
University of California, San Diego
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Principal Investigator: Herbert H. Severson, PhD Oregon Research Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Oregon Research Institute Identifier: NCT00820495    
Other Study ID Numbers: R01CA084225 ( U.S. NIH Grant/Contract )
R01CA084225 ( U.S. NIH Grant/Contract )
First Posted: January 12, 2009    Key Record Dates
Last Update Posted: August 5, 2013
Last Verified: August 2013
Keywords provided by Oregon Research Institute:
Smokeless tobacco
Chewing Tobacco
Additional relevant MeSH terms:
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Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders