Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users
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ClinicalTrials.gov Identifier: NCT00820495 |
Recruitment Status :
Completed
First Posted : January 12, 2009
Last Update Posted : August 5, 2013
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Condition or disease | Intervention/treatment | Phase |
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Tobacco Use Disorder | Behavioral: Web + Phone Behavioral: Web Only Behavioral: Phone Only Behavioral: Usual Care | Phase 2 |
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.
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 |

Arm | Intervention/treatment |
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Experimental: Web + Phone
Highly interactive tailored Web-based smokeless tobacco cessation program plus phone counseling
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Behavioral: Web + Phone
Web + Phone
Other Names:
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Experimental: Web Only
Highly interactive tailored Web-based smokeless tobacco cessation program
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Behavioral: Web Only
Web Only
Other Name: web-assisted intervention |
Experimental: Phone Only
Phone counseling intervention for smokeless tobacco cessation
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Behavioral: Phone Only
Phone Only
Other Names:
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Experimental: Control
Usual care (initial call plus self-help materials)
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Behavioral: Usual Care
Usual Care
Other Names:
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- Prolonged abstinence from all tobacco [ Time Frame: 3 months and 6 months ]
- 7-day point prevalence for smokeless tobacco use [ Time Frame: 3 months and 6 months ]
- 7-day point prevalence for all tobacco use [ Time Frame: 3 months and 6 months ]

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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

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 ClinicalTrials.gov identifier (NCT number): NCT00820495
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 |
Principal Investigator: | Herbert H. Severson, PhD | Oregon Research Institute |
Responsible Party: | Oregon Research Institute |
ClinicalTrials.gov 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 |
Smokeless tobacco Chewing Tobacco Internet Adolescent |
Tobacco Use Disorder Substance-Related Disorders Chemically-Induced Disorders Mental Disorders |