An Internet-Based Smokeless Tobacco Cessation Program for Teens - Full Text View

Sponsor:	Oregon Research Institute
Information provided by:	Oregon Research Institute
ClinicalTrials.gov Identifier:	NCT00680615

Purpose

To compare the efficacy of a targeted, tailored, and highly interactive smokeless tobacco cessation website to a website with more static information that is similar to websites that can be found through a typical Internet search.

Condition	Intervention	Phase
Smokeless Tobacco Use	Behavioral: Tailored, enhanced condition Behavioral: Usual Care	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	QuitSpit: An Internet-Based Smokeless Tobacco Cessation Program for Teens

Resource links provided by NLM:

MedlinePlus related topics: Smokeless Tobacco

Drug Information available for: Lobeline Lobeline sulfate

U.S. FDA Resources

Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:

Abstinence from all tobacco [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
Abstinence from smokeless tobacco [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the relative effectiveness of the two programs on secondary outcomes, including reduction in smokeless tobacco use, number of quit attempts, and confidence in quitting. [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]
Identify participant characteristics, including demographic characteristics, initial smokeless tobacco use and dependence, and patterns of program use that predict treatment outcomes. [ Time Frame: 3 months and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	1550
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Usual Care: Experimental	Behavioral: Usual Care The Usual Care condition will provide access to typical smokeless tobacco cessation information and links to commonly available Web-based smokeless tobacco cessation resources.
Enhanced: Experimental	Behavioral: Tailored, enhanced condition Intervention will provide a personalized, interactive tobacco cessation Web application, based on existing empirically validated smokeless tobacco cessation programs.

Eligibility

Ages Eligible for Study:	14 Years to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

14-25 years of age
Have access to the Internet
Currently using smokeless tobacco products
Currently contemplating quitting all tobacco products
Able to read and write English; and
Willing to share phone number, e-mail, and mailing address with the research project

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680615

Locations

United States, Oregon
Oregon Research Institute	Recruiting
Eugene, Oregon, United States, 97403
Contact: Herbert H. Severson, PhD 541-484-2123 herb@ori.org
Principal Investigator: Herbert H. Severson, PhD
Principal Investigator: Brian G. Danaher, PhD

Sponsors and Collaborators

Oregon Research Institute

Investigators

Principal Investigator:	Herbert H. Severson, PhD	Oregon Research Institute
Principal Investigator:	Brian G Danaher, PhD	Oregon Research Institute

More Information

No publications provided

Responsible Party:	Oregon Research Institute ( Herbert H. Severson, PhD )
Study ID Numbers:	R01- CA118575
Study First Received:	May 16, 2008
Last Updated:	October 6, 2009
ClinicalTrials.gov Identifier:	NCT00680615 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Oregon Research Institute:

Smokeless tobacco

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Nicotinic Agonists
Physiological Effects of Drugs
Cholinergic Agents

Pharmacologic Actions
Lobeline
Autonomic Agents
Therapeutic Uses
Ganglionic Stimulants
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010