Telephone Counseling for Snuff Users

August 21, 2023 updated by: HealthPartners Institute

Proactive Telephone Counseling With Rural Smokeless Tobacco Users

The primary objective is to evaluate the effectiveness of telephone-based counseling in promoting smokeless tobacco cessation among residents of Minnesota. It is hypothesized that a greater proportion of individuals assigned to the proactive telephone calls will quit their use of smokeless tobacco products and all tobacco products compared to the comparison group not receiving those calls.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Smokeless Tobacco (ST) users have not been the focus of tobacco control campaigns in Minnesota. However, there are a significant number of adults in Minnesota who regularly use ST. There is a need for a low-cost cessation program that can be widely delivered to ST users who may have little or no access to conventional and/or group treatments. Self-help interventions can make a significant contribution in reaching this population. The telephone provides a unique low-cost delivery system that can expand the reach of a self-help cessation program to underserved groups of tobacco users. The primary objective is to evaluate the effectiveness of telephone-based counseling in promoting smokeless tobacco cessation among Minnesota residents. It is hypothesized that a greater proportion of individuals assigned to the telephone calling group will quit their use of smokeless tobacco products and all tobacco products compared to the comparison group not receiving calls. We plan to recruit 400 smokeless tobacco users who are interested in quitting their use of smokeless tobacco and randomize them to telephone counseling for smokeless tobacco cessation or to a comparison group that receives the same mailed self-help materials. All subjects will be assessed pre-intervention, and at 3- and 6-months.

Study Type

Interventional

Enrollment

400

Phase

  • Not Applicable

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

  • United States
    • Minnesota
      • Bloomington, Minnesota, United States, 55420
        • HealthPartners Research Foundation

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Age 18 or older. Use snuff or chewing tobacco weekly. Snuff or chewing tobacco are primary tobacco use.

Exclusion Criteria:

No access to a telephone. Primary tobacco use is cigarettes, cigar or pipe tobacco.

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 Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Point prevalent abstinence from all tobacco after 3 months.
Point prevalent abstinence from all tobacco after 3 months.
Prolonged abstinence from all tobacco after 3 months.
Prolonged abstinence from all tobacco after 3 months
Number of subjects who abstained for at least 24 hours.
Number of subjects who abstained for at least 24 hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Assess the relative costs of delivering the 2 interventions.
Assess the relative costs of delivering the 2 interventions.
Use baseline data to predict successful tobacco cessation.
Use baseline data to predict successful tobacco cessation.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthPartners Institute

Collaborators

Minnesota Partnership for Action Against Tobacco

Investigators

  • Principal Investigator: Nancy E Sherwood, PhD, HealthPartners Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 2004

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

December 13, 2005

First Submitted That Met QC Criteria

December 13, 2005

First Posted (Estimated)

December 15, 2005

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 21, 2023

Last Verified

April 1, 2007

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 03-119
  • RC -2004-0010

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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