Smokeless TobaccoNCT00265681
Telephone Counseling for Snuff Users
A study testing Phone counseling and written materials in people with Smokeless Tobacco and Tobacco Use Cessation, run by HealthPartners Institute at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smokeless Tobacco, Tobacco Use Cessation
- What is being tested?
- Phone counseling and written materials
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to Dec 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older. Use snuff or chewing tobacco weekly. Snuff or chewing tobacco are primary tobacco use.
Who cannot join
- No access to a telephone. Primary tobacco use is cigarettes, cigar or pipe tobacco.
Trial locations and contacts
1 site in 1 country.
United States1 site
HealthPartners Research Foundation
Bloomington, Minnesota, 55420
About this study
Official title: Proactive Telephone Counseling With Rural Smokeless Tobacco 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.
Read the 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.
- Conditions
- Smokeless Tobacco, Tobacco Use Cessation
- Being tested
- Phone counseling and written materials
- Keywords
- smokeless tobacco cessation, chewing tobacco, oral tobacco, smokeless tobacco, telephone, counseling
- Medical subject headings
- Tobacco Use, Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phone counseling and written materialsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (2)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2005 (estimated)
- Study startNov 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Smokeless TobaccoStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Minnesota Partnership for Action Against Tobacco
- Responsible party
- Sponsor
- Investigators
- Nancy E Sherwood, PhD, Principal investigator, HealthPartners Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00265681
- Sponsor's protocol ID
- 03-119
- Other IDs
- RC -2004-0010
- Status last verified
- Apr 2007
- First submitted
- 13 Dec 2005
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15228971
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proactive Telephone Counseling With Rural Smokeless Tobacco Users
- ClinicalTrials.gov ID
- NCT00265681
- Acronym / sponsor ID
- 03-119
- Conditions
- Smokeless Tobacco, Tobacco Use Cessation
- Keywords
- smokeless tobacco cessation, chewing tobacco, oral tobacco, smokeless tobacco, telephone, counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Collaborators
- Minnesota Partnership for Action Against Tobacco
- Study start
- Nov 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 15 Dec 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 or older. Use snuff or chewing tobacco weekly. Snuff or chewing tobacco are primary tobacco use.
Key exclusion criteria (1 listed)
- No access to a telephone. Primary tobacco use is cigarettes, cigar or pipe tobacco.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phone counseling and written materials | Behavioural | – |
Primary outcome
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.
2 secondary outcomes
Assess the relative costs of delivering the 2 interventions.
Use baseline data to predict successful tobacco cessation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Background: PubMed 15228971Boyle 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nancy E Sherwood, PhD principal investigator
HealthPartners Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phone counseling and written materials in people with Smokeless Tobacco and Tobacco Use Cessation, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Point prevalent abstinence from all tobacco after 3 months.. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00265681, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.