NCT00680615

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,716

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2008

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2008

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
Last Updated

September 5, 2012

Status Verified

September 1, 2012

Enrollment Period

3.8 years

First QC Date

May 16, 2008

Last Update Submit

September 3, 2012

Conditions

Smokeless Tobacco Use

Keywords

Smokeless tobacco

Outcome Measures

Primary Outcomes (2)

  • Abstinence from all tobacco

    3 months and 6 months

  • Abstinence from smokeless tobacco

    3 months and 6 months

Secondary Outcomes (2)

  • 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

  • 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

Study Arms (2)

Usual Care

EXPERIMENTAL
Behavioral: Usual Care

Enhanced

EXPERIMENTAL
Behavioral: Tailored, enhanced condition

Interventions

Tailored, enhanced conditionBEHAVIORAL

Intervention will provide a personalized, interactive tobacco cessation Web application, based on existing empirically validated smokeless tobacco cessation programs.

Enhanced
Usual CareBEHAVIORAL

The Usual Care condition will provide access to typical smokeless tobacco cessation information and links to commonly available Web-based smokeless tobacco cessation resources.

Usual Care

Eligibility Criteria

Age14 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Tobacco Use

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Herbert H. Severson, PhD

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

  • Brian G Danaher, PhD

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2008

First Posted

May 20, 2008

Study Start

May 1, 2008

Primary Completion

March 1, 2012

Study Completion

March 1, 2012

Last Updated

September 5, 2012

Record last verified: 2012-09

Locations

US(1)