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

Treatment of Smokeless Tobacco Users

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.

Study Overview

• Status: Completed
• Conditions: Tobacco Use Disorder
• Intervention / Treatment: Drug: Tobacco free snuff

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.

• Study Type: Interventional
• Enrollment (Actual): 138
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 1; Reduction of tobacco use by substituting tobacco free snuff.	Drug: Tobacco free snuff; Tobacco free snuff; Other Names: Smokey Mountain
PLACEBO_COMPARATOR: 2; Reduction of tobacco use by using behavioral techniques.	Drug: Tobacco free snuff; Tobacco free snuff; Other Names: Smokey Mountain

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Motivation and self-efficacy (measured at Weeks 8, 12, and 26)	Week 8, 12, and 26

Collaborators and Investigators

• Sponsor: National Institute on Drug Abuse (NIDA)

Study record dates

Study Major Dates

• Study Start: December 1, 2002
• Primary Completion (ACTUAL): May 1, 2005
• Study Completion (ACTUAL): May 1, 2005

Study Registration Dates

• First Submitted: September 16, 2005
• First Submitted That Met QC Criteria: September 16, 2005
• First Posted (ESTIMATE): September 22, 2005

Study Record Updates

• Last Update Posted (ESTIMATE): January 10, 2017
• Last Update Submitted That Met QC Criteria: January 9, 2017
• Last Verified: June 1, 2008

More Information

Terms related to this study

• Keywords: Smokeless tobacco, harm reduction
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder
• Other Study ID Numbers: NIDA-14404-2; DPMC (Other Identifier: NIDA); R01-14404-2