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Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users
This study is not yet open for participant recruitment.
Study NCT00820495   Information provided by Oregon Research Institute
First Received: January 8, 2009   Last Updated: January 9, 2009   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

January 8, 2009
January 9, 2009
March 2009
  • Prolonged abstinence from smokeless tobacco [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
  • Prolonged abstinence from all tobacco [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00820495 on ClinicalTrials.gov Archive Site
  • 7-day point prevalence for smokeless tobacco use [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
  • 7-day point prevalence for all tobacco use [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
Same as current
 
Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users
Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users

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.

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.

Phase II
Interventional
Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment
  • Smokeless Tobacco
  • Tobacco Use Disorder
  • Behavioral: Web + Phone
  • Behavioral: Web Only
  • Behavioral: Phone Only
  • Behavioral: Usual Care
  • Experimental: Highly interactive tailored Web-based smokeless tobacco cessation program plus phone counseling
  • Experimental: Highly interactive tailored Web-based smokeless tobacco cessation program
  • Experimental: Phone counseling intervention for smokeless tobacco cessation
  • Experimental: Usual care (initial call plus self-help materials)
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Not yet recruiting
1464
March 2012
March 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
 
United States
 
 
NCT00820495
Herbert H. Severson, Ph.D., Oregon Research Institute
R01- CA084225
Oregon Research Institute
University of California, San Diego
Principal Investigator: Herbert H. Severson, PhD Oregon Research Institute
Oregon Research Institute
January 2009

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.