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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00680615
Other study ID # R01CA118575
Secondary ID
Status Completed
Phase Phase 2
First received May 16, 2008
Last updated September 3, 2012
Start date May 2008
Est. completion date March 2012

Study information

Verified date September 2012
Source Oregon Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1716
Est. completion date March 2012
Est. primary completion date March 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 14 Years to 25 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Oregon Research Institute Eugene Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Abstinence from all tobacco 3 months and 6 months No
Primary Abstinence from smokeless tobacco 3 months and 6 months No
Secondary 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. 3 months and 6 months No
Secondary Identify participant characteristics, including demographic characteristics, initial smokeless tobacco use and dependence, and patterns of program use that predict treatment outcomes. 3 months and 6 months No
See also
  Status Clinical Trial Phase
Completed NCT00939029 - Highdose Nicotine Patch Therapy for Smokeless Tobacco Use Phase 2/Phase 3
Completed NCT00392379 - Nicotine Lozenges for Treatment of Smokeless Tobacco Addiction Phase 3
Completed NCT01067586 - Novel Determinants and Measures of Smokeless Tobacco Use: Study 1
Completed NCT00888459 - A Pilot Study Evaluating Nicotine Lozenges and Self Help Phase 2