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OpenTrials
Completed

NCT Number: NCT00265681

Telephone Counseling for Snuff 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

HealthPartners Research Foundation

Bloomington, Minnesota, 55420, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Phone counseling and written materials

Behavioral

Primary outcomes

  1. Point prevalent abstinence from all tobacco after 3 months.

    Point prevalent abstinence from all tobacco after 3 months.

  2. Prolonged abstinence from all tobacco after 3 months.

    Prolonged abstinence from all tobacco after 3 months

  3. Number of subjects who abstained for at least 24 hours.

    Number of subjects who abstained for at least 24 hours.

Secondary outcomes

  1. Assess the relative costs of delivering the 2 interventions.

    Assess the relative costs of delivering the 2 interventions.

  2. Use baseline data to predict successful tobacco cessation.

    Use baseline data to predict successful tobacco cessation.

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • Minnesota Partnership for Action Against Tobacco

Registry information

Official study title

Proactive Telephone Counseling With Rural Smokeless Tobacco Users

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Dec 15, 2005
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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