An Internet-Based Smokeless Tobacco Cessation Program for Teens - Tabular View

Tracking Information

First Received Date ^ICMJE

May 16, 2008

Last Updated Date

October 6, 2009

Start Date ^ICMJE

May 2008

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00680615 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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: 6 weeks 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: 6 weeks and 6 months ] [ Designated as safety issue: No ]

Descriptive Information

Brief Title ^ICMJE

An Internet-Based Smokeless Tobacco Cessation Program for Teens

Official Title ^ICMJE

QuitSpit: An Internet-Based Smokeless Tobacco Cessation Program for Teens

Brief Summary

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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Allocation:  Randomized
Control:  Active Control
Endpoint Classification:  Efficacy Study
Intervention Model:  Parallel Assignment
Masking:  Open Label
Primary Purpose:  Treatment

Condition ^ICMJE

Smokeless Tobacco Use

Intervention ^ICMJE

Behavioral: Tailored, enhanced condition
Intervention will provide a personalized, interactive tobacco cessation Web application, based on existing empirically validated smokeless tobacco cessation programs.
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.

Study Arms / Comparison Groups

Usual Care: Experimental
Intervention: Behavioral: Usual Care
Enhanced: Experimental
Intervention: Behavioral: Tailored, enhanced condition

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

1550

Estimated Completion Date

May 2010

Estimated Primary Completion Date

May 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

14 Years to 25 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00680615

Responsible Party

Herbert H. Severson, PhD, Oregon Research Institute

Study ID Numbers ^ICMJE

R01- CA118575

Study Sponsor ^ICMJE

Oregon Research Institute

Collaborators ^ICMJE

Investigators ^ICMJE

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

Information Provided By

Oregon Research Institute

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP