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Sponsors and Collaborators: |
Oregon Research Institute University of California, San Diego |
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Information provided by: | Oregon Research Institute |
ClinicalTrials.gov Identifier: | NCT00820495 |
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 | Intervention | Phase |
---|---|---|
Smokeless Tobacco Tobacco Use Disorder |
Behavioral: Web + Phone Behavioral: Web Only Behavioral: Phone Only Behavioral: Usual Care |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Dose Comparison, Parallel Assignment |
Official Title: | Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users |
Estimated Enrollment: | 1464 |
Study Start Date: | March 2009 |
Estimated Study Completion Date: | March 2012 |
Estimated Primary Completion Date: | March 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Web + Phone: Experimental
Highly interactive tailored Web-based smokeless tobacco cessation program plus phone counseling
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Behavioral: Web + Phone
Web + Phone
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Web Only: Experimental
Highly interactive tailored Web-based smokeless tobacco cessation program
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Behavioral: Web Only
Web Only
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Phone Only: Experimental
Phone counseling intervention for smokeless tobacco cessation
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Behavioral: Phone Only
Phone Only
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Control: Experimental
Usual care (initial call plus self-help materials)
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Behavioral: Usual Care
Usual Care
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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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
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 |
Principal Investigator: | Herbert H. Severson, PhD | Oregon Research Institute |
Responsible Party: | Oregon Research Institute ( Herbert H. Severson, Ph.D. ) |
Study ID Numbers: | R01- CA084225, R01- CA084225 |
Study First Received: | January 8, 2009 |
Last Updated: | January 9, 2009 |
ClinicalTrials.gov Identifier: | NCT00820495 |
Health Authority: | United States: Institutional Review Board |
Smokeless tobacco Chewing Tobacco Internet Adolescent |
Lobeline Mental Disorders Tobacco Use Disorder Substance-Related Disorders Disorders of Environmental Origin |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Cholinergic Agonists Autonomic Agents Therapeutic Uses |
Nicotinic Agonists Physiological Effects of Drugs Ganglionic Stimulants Peripheral Nervous System Agents Cholinergic Agents Pharmacologic Actions |