Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users

This study has been completed.
Sponsor:
Collaborators:
University of California, San Diego
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT00820495
First received: January 8, 2009
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

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
Tobacco Use Disorder
Behavioral: Web + Phone
Behavioral: Web Only
Behavioral: Phone Only
Behavioral: Usual Care
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of a Web-Assisted Quitline for Smokeless Tobacco Users

Resource links provided by NLM:


Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • Prolonged abstinence from all tobacco [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 7-day point prevalence for smokeless tobacco use [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
  • 7-day point prevalence for all tobacco use [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]

Enrollment: 1683
Study Start Date: May 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00820495

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
University of California, San Diego
Investigators
Principal Investigator: Herbert H. Severson, PhD Oregon Research Institute
  More Information

No publications provided

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT00820495     History of Changes
Other Study ID Numbers: R01- CA084225, R01CA084225
Study First Received: January 8, 2009
Last Updated: August 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Research Institute:
Smokeless tobacco
Chewing Tobacco
Internet
Adolescent

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
Lobeline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 20, 2014