Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users

Tobacco Use Disorder Clinical Trial

Official title:

Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00820495
• Other study ID #: R01CA084225
• Secondary ID: R01CA084225
• Status: Completed
• Phase: Phase 2
• First received: January 8, 2009
• Last updated: August 2, 2013
• Start date: May 2009
• Est. completion date: May 2012

Study information

• Verified date: August 2013
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1683
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Behavioral:
• Web + Phone
Web + Phone
• Web Only
Web Only
• Phone Only
Phone Only
• Usual Care
Usual Care

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon
United States	University of California, San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Oregon Research Institute	National Cancer Institute (NCI), University of California, San Diego

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prolonged abstinence from all tobacco		3 months and 6 months	No
Secondary	7-day point prevalence for smokeless tobacco use		3 months and 6 months	No
Secondary	7-day point prevalence for all tobacco use		3 months and 6 months	No