Telephone Counseling for Snuff Users

This study has been completed.
Sponsor:
Collaborator:
Minnesota Partnership for Action Against Tobacco
Information provided by:
HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier:
NCT00265681
First received: December 13, 2005
Last updated: April 3, 2007
Last verified: April 2007
  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

Resource links provided by NLM:


Further study details as provided by HealthPartners Institute for Education and Research:

Primary Outcome Measures:
  • 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.

Secondary Outcome Measures:
  • 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
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265681

Locations
United States, Minnesota
HealthPartners Research Foundation
Bloomington, Minnesota, United States, 55420
Sponsors and Collaborators
HealthPartners Institute for Education and Research
Minnesota Partnership for Action Against Tobacco
Investigators
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:
Tobacco Use Disorder
Substance-Related Disorders
Mental Disorders
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 July 28, 2014