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An Internet-Based Smokeless Tobacco Cessation Program for Teens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT00680615
First received: May 16, 2008
Last updated: September 3, 2012
Last verified: September 2012
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: QuitSpit: An Internet-Based Smokeless Tobacco Cessation Program for Teens

Resource links provided by NLM:

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 ]

Enrollment: 1716
Study Start Date: May 2008
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Usual Care 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.
Experimental: Enhanced 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
Eugene, Oregon, United States, 97403
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
ClinicalTrials.gov Identifier: NCT00680615     History of Changes
Other Study ID Numbers: R01- CA118575
Study First Received: May 16, 2008
Last Updated: September 3, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Research Institute:
Smokeless tobacco

Additional relevant MeSH terms:
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 May 19, 2013