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Effectiveness of Using Tobacco Free Snuff in Reducing Negative Effects of Smokeless Tobacco Use

Primary Purpose

Tobacco Use Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tobacco free snuff
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring Smokeless tobacco, harm reduction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Not interested in quitting smokeless tobacco use within 90 days of study entry Used smokeless tobacco at least six times a day for 6 months prior to study entry Agree to use an effective form of contraception throughout the study Exclusion Criteria: Current use of tobacco or nicotine products other than ST Pregnant or breastfeeding Any unstable medical condition Use of any medication that may affect tobacco use or be affected by reduction of tobacco use DSM-IV diagnosis of any psychiatric disorders or substance abuse disorders within 6 months prior to study entry Use of any psychotropic medications within 6 months prior to study entry

Sites / Locations

  • University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Reduction of tobacco use by substituting tobacco free snuff.

Reduction of tobacco use by using behavioral techniques.

Outcomes

Primary Outcome Measures

Percent reduction in use
Toxicity profile of carcinogen metabolites
Number of unsuccessful quit attempts
Abstinence (measured at Weeks 8, 12, and 26)

Secondary Outcome Measures

Motivation and self-efficacy (measured at Weeks 8, 12, and 26)

Full Information

First Posted
September 16, 2005
Last Updated
January 9, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT00218270
Brief Title
Effectiveness of Using Tobacco Free Snuff in Reducing Negative Effects of Smokeless Tobacco Use
Official Title
Treatment of Smokeless Tobacco Users
Study Type
Interventional

2. Study Status

Record Verification Date
June 2008
Overall Recruitment Status
Completed
Study Start Date
December 2002 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Though spit tobacco is smokeless, it still affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. Long-term effects of smokeless tobacco (ST) include tooth abrasion, gum recession, mouth disease, loss of bone in the jaw, yellowing of teeth, and chronic bad breath. This study will assess the effectiveness of using tobacco free snuff in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake.
Detailed Description
Spit tobacco presents as many health risks to its users as smoking tobacco. Although a significant number of ST users recognize the importance of quitting, many either do not want to quit or feel it is impossible. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. However, approaches to help ST users reach this goal have not been studied. This study will assess the effectiveness of using tobacco-free snuff in reducing levels of exposure to tobacco and associated toxicity, as well as enhancing motivation to either quit or sustain lower levels of nicotine intake. Participants will be randomly assigned to receive either treatment with tobacco-free snuff or treatment without it. All participants will be encouraged to reduce nicotine intake by 50% during the first four weeks and by 75% the following four weeks. Participants receiving the tobacco-free snuff will be asked to alternate the use of their usual brand of ST with tobacco-free snuff in order to achieve the targeted reduction. Participants not receiving the tobacco-free snuff will only be informed to try to cut down their tobacco use to the targeted reduction. Study visits will occur once weekly during the 8-week treatment period. Assessments will include vital signs, physiological measures related to tobacco use, and measures of motivation and self-efficacy to quit ST. The number of participants who either do not complete treatment, reduce nicotine intake, or quit completely will be assessed at the Week 8 study visit and at follow-up visits, which will be held at Weeks 12 and 26.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use Disorder
Keywords
Smokeless tobacco, harm reduction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
138 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Reduction of tobacco use by substituting tobacco free snuff.
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Reduction of tobacco use by using behavioral techniques.
Intervention Type
Drug
Intervention Name(s)
Tobacco free snuff
Other Intervention Name(s)
Smokey Mountain
Intervention Description
Tobacco free snuff
Primary Outcome Measure Information:
Title
Percent reduction in use
Time Frame
Week 8, 12, and 26
Title
Toxicity profile of carcinogen metabolites
Time Frame
Week 8, 12, and 26
Title
Number of unsuccessful quit attempts
Time Frame
Week 8, 12, and 26
Title
Abstinence (measured at Weeks 8, 12, and 26)
Time Frame
Week 8, 12, and 26
Secondary Outcome Measure Information:
Title
Motivation and self-efficacy (measured at Weeks 8, 12, and 26)
Time Frame
Week 8, 12, and 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Not interested in quitting smokeless tobacco use within 90 days of study entry Used smokeless tobacco at least six times a day for 6 months prior to study entry Agree to use an effective form of contraception throughout the study Exclusion Criteria: Current use of tobacco or nicotine products other than ST Pregnant or breastfeeding Any unstable medical condition Use of any medication that may affect tobacco use or be affected by reduction of tobacco use DSM-IV diagnosis of any psychiatric disorders or substance abuse disorders within 6 months prior to study entry Use of any psychotropic medications within 6 months prior to study entry
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorothy Hatsukami, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

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Effectiveness of Using Tobacco Free Snuff in Reducing Negative Effects of Smokeless Tobacco Use

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