Telephone Counseling for Snuff Users
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Smokeless Tobacco Tobacco Use Cessation |
Behavioral: Phone counseling and written materials |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Proactive Telephone Counseling With Rural Smokeless Tobacco Users |
- Point prevalent 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.
- Assess the relative costs of delivering the 2 interventions.
- Use baseline data to predict successful tobacco cessation.
| Estimated Enrollment: | 400 |
| Study Start Date: | November 2004 |
| Study Completion Date: | December 2006 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United States, Minnesota | |
| HealthPartners Research Foundation | |
| Bloomington, Minnesota, United States, 55420 | |
| Principal Investigator: | Nancy E Sherwood, PhD | HealthPartners Institute for Education and Research |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00265681 History of Changes |
| Other Study ID Numbers: | 03-119, RC -2004-0010 |
| Study First Received: | December 13, 2005 |
| Last Updated: | April 3, 2007 |
| Health Authority: | United States: Federal Government |
Keywords provided by HealthPartners Institute for Education and Research:
|
smokeless tobacco cessation chewing tobacco oral tobacco |
smokeless tobacco telephone counseling |
Additional relevant MeSH terms:
|
Lobeline Ganglionic Stimulants Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Nicotinic Agonists |
Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Respiratory System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 17, 2013