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OpenTrials
Completed

NCT Number: NCT00820495

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of California, San Diego, San Diego, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Web + Phone

Behavioral

Web + Phone

Other names: web-assisted intervention, quitline, helpline

Web Only

Behavioral

Web Only

Other names: web-assisted intervention

Phone only

Behavioral

Phone Only

Other names: helpline, quitline

Usual Care

Behavioral

Usual Care

Other names: helpline, quitline

Primary outcomes

  1. Prolonged abstinence from all tobacco

    Time frame: 3 months and 6 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Oregon Research Institute

Other

Collaborators

  • National Cancer Institute (NCI)
  • University of California, San Diego

Registry information

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Jan 12, 2009
Registry last updated
Aug 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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