Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users

• ClinicalTrials.gov Identifier: NCT00820495
• Recruitment Status: Completed
• First Posted: January 12, 2009
• Last Update Posted: August 5, 2013
• Sponsor: Oregon Research Institute
• Collaborators: National Cancer Institute (NCI); University of California, San Diego
• Information provided by (Responsible Party): Oregon Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Tobacco Use Disorder	Behavioral: Web + Phone; Behavioral: Web Only; Behavioral: Phone Only; Behavioral: Usual Care	Phase 2

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.

Study Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Web + Phone; Highly interactive tailored Web-based smokeless tobacco cessation program plus phone counseling	Behavioral: Web + Phone; Web + Phone; Other Names: web-assisted intervention; quitline; helpline
Experimental: Web Only; Highly interactive tailored Web-based smokeless tobacco cessation program	Behavioral: Web Only; Web Only; Other Name: web-assisted intervention
Experimental: Phone Only; Phone counseling intervention for smokeless tobacco cessation	Behavioral: Phone Only; Phone Only; Other Names: helpline; quitline
Experimental: Control; Usual care (initial call plus self-help materials)	Behavioral: Usual Care; Usual Care; Other Names: helpline; quitline

Outcome Measures

Primary Outcome Measures :

1. Prolonged abstinence from all tobacco [ Time Frame: 3 months and 6 months ]

Secondary Outcome Measures :

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 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

• none

Contacts and Locations

Locations

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

Sponsors and Collaborators

Oregon Research Institute

National Cancer Institute (NCI)

University of California, San Diego

Investigators

• Principal Investigator: Herbert H. Severson, PhD; Oregon Research Institute

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Danaher BG, Severson HH, Zhu SH, Andrews JA, Cummins SE, Lichtenstein E, Tedeschi GJ, Hudkins C, Widdop C, Crowley R, Seeley JR. Randomized Controlled Trial of the Combined Effects of Web and Quitline Interventions for Smokeless Tobacco Cessation. Internet Interv. 2015 May 1;2(2):143-151.

• 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
• Last Update Posted: August 5, 2013
• Last Verified: August 2013

Keywords provided by Oregon Research Institute:

Smokeless tobacco; Chewing Tobacco; Internet; Adolescent

Additional relevant MeSH terms:

Tobacco Use Disorder; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders