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Clinical Trials/NCT00820495
NCT00820495
Completed
Phase 2

Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users

Oregon Research Institute2 sites in 1 country1,683 target enrollmentMay 2009

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Tobacco Use Disorder
Sponsor
Oregon Research Institute
Enrollment
1683
Locations
2
Primary Endpoint
Prolonged abstinence from all tobacco
Status
Completed
Last Updated
12 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
May 2009
End Date
May 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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:

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Prolonged abstinence from all tobacco

Time Frame: 3 months and 6 months

Secondary Outcomes

  • 7-day point prevalence for all tobacco use(3 months and 6 months)
  • 7-day point prevalence for smokeless tobacco use(3 months and 6 months)

Study Sites (2)

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