Telephone Counseling for Snuff Users

Study Overview
=================
Brief 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.

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.

Official Title
-----------------
Proactive Telephone Counseling With Rural Smokeless Tobacco Users

Conditions
-----------------
Smokeless Tobacco, Tobacco Use Cessation

Intervention / Treatment
-----------------
* Behavioral: Phone counseling and written materials


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Phone counseling and written materials|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Time Frame |
| --- | --- | --- |
| 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. |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
telephone, smokeless tobacco cessation, chewing tobacco, oral tobacco, smokeless tobacco, counseling