NCT00820495

Brief Summary

The purpose of this record is to test whether (a) participants who receive a Web-based smokeless tobacco cessation intervention will be more likely to be abstinent than participants who do not receive this intervention, and (b) whether participants who receive a telephone quitline intervention will be more likely to be abstinent than participants who are not in a quitline intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,683

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2009

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

January 8, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 12, 2009

Completed
4 months until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

August 5, 2013

Status Verified

August 1, 2013

Enrollment Period

3 years

First QC Date

January 8, 2009

Last Update Submit

August 2, 2013

Conditions

Keywords

Smokeless tobaccoChewing TobaccoInternetAdolescent

Outcome Measures

Primary Outcomes (1)

  • Prolonged abstinence from all tobacco

    3 months and 6 months

Secondary Outcomes (2)

  • 7-day point prevalence for smokeless tobacco use

    3 months and 6 months

  • 7-day point prevalence for all tobacco use

    3 months and 6 months

Study Arms (4)

Web + Phone

EXPERIMENTAL

Highly interactive tailored Web-based smokeless tobacco cessation program plus phone counseling

Behavioral: Web + Phone

Web Only

EXPERIMENTAL

Highly interactive tailored Web-based smokeless tobacco cessation program

Behavioral: Web Only

Phone Only

EXPERIMENTAL

Phone counseling intervention for smokeless tobacco cessation

Behavioral: Phone Only

Control

EXPERIMENTAL

Usual care (initial call plus self-help materials)

Behavioral: Usual Care

Interventions

Web + PhoneBEHAVIORAL

Web + Phone

Also known as: web-assisted intervention, quitline, helpline
Web + Phone
Web OnlyBEHAVIORAL

Web Only

Also known as: web-assisted intervention
Web Only
Phone OnlyBEHAVIORAL

Phone Only

Also known as: helpline, quitline
Phone Only
Usual CareBEHAVIORAL

Usual Care

Also known as: helpline, quitline
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • current users of smokeless tobacco products (snuff or chewing tobacco)
  • use of smokeless tobacco products for at least 1 year
  • use of at least one tin or pouch per week
  • interest in quitting all tobacco
  • U.S. resident 18 years of age or older
  • ability to read English
  • willingness to share a phone number, e-mail, and mailing address
  • use of personal Internet e-mail account at least once per week
  • informed consent

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of California, San Diego

San Diego, California, 92111, United States

Location

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Related Publications (1)

  • Danaher BG, Severson HH, Zhu SH, Andrews JA, Cummins SE, Lichtenstein E, Tedeschi GJ, Hudkins C, Widdop C, Crowley R, Seeley JR. Randomized Controlled Trial of the Combined Effects of Web and Quitline Interventions for Smokeless Tobacco Cessation. Internet Interv. 2015 May 1;2(2):143-151. doi: 10.1016/j.invent.2015.02.005.

MeSH Terms

Conditions

Tobacco Use DisorderTobacco Use

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersBehavior

Study Officials

  • Herbert H. Severson, 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

January 8, 2009

First Posted

January 12, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

August 5, 2013

Record last verified: 2013-08

Locations