- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00680615
An Internet-Based Smokeless Tobacco Cessation Program for Teens
September 3, 2012 updated by: Oregon Research Institute
QuitSpit: An Internet-Based Smokeless Tobacco Cessation Program for Teens
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1716
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Oregon
-
Eugene, Oregon, United States, 97403
- Oregon Research Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
14 years to 25 years (ADULT, CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 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
|
Intervention will provide a personalized, interactive tobacco cessation Web application, based on existing empirically validated smokeless tobacco cessation programs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Abstinence from all tobacco
Time Frame: 3 months and 6 months
|
3 months and 6 months
|
|
Abstinence from smokeless tobacco
Time Frame: 3 months and 6 months
|
3 months and 6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
3 months and 6 months
|
|
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
|
3 months and 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2008
Primary Completion (ACTUAL)
March 1, 2012
Study Completion (ACTUAL)
March 1, 2012
Study Registration Dates
First Submitted
May 16, 2008
First Submitted That Met QC Criteria
May 19, 2008
First Posted (ESTIMATE)
May 20, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
September 5, 2012
Last Update Submitted That Met QC Criteria
September 3, 2012
Last Verified
September 1, 2012
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- R01CA118575 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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