Telephone Counseling for Snuff Users

Tobacco Use Cessation Clinical Trial

Official title:

Proactive Telephone Counseling With Rural Smokeless Tobacco Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00265681
• Other study ID #: 03-119
• Secondary ID: RC -2004-0010
• Status: Completed
• Phase: N/A
• Start date: November 2004
• Est. completion date: December 2006

Study information

• Verified date: April 2007
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smokeless Tobacco
• Tobacco Use Cessation

Intervention

Behavioral:
• Phone counseling and written materials

Locations

Country	Name	City	State
United States	HealthPartners Research Foundation	Bloomington	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	Minnesota Partnership for Action Against Tobacco

Country where clinical trial is conducted

United States, 

References & Publications (1)

Boyle RG, Pronk NP, Enstad CJ. A randomized trial of telephone counseling with adult moist snuff users. Am J Health Behav. 2004 Jul-Aug;28(4):347-51. doi: 10.5993/ajhb.28.4.6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Point prevalent abstinence from all tobacco after 3 months.	Point prevalent abstinence from all tobacco after 3 months.
Primary	Prolonged abstinence from all tobacco after 3 months.	Prolonged abstinence from all tobacco after 3 months
Primary	Number of subjects who abstained for at least 24 hours.	Number of subjects who abstained for at least 24 hours.
Secondary	Assess the relative costs of delivering the 2 interventions.	Assess the relative costs of delivering the 2 interventions.
Secondary	Use baseline data to predict successful tobacco cessation.	Use baseline data to predict successful tobacco cessation.