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

Tobacco Use Disorder Clinical Trial

Official title:

Treatment of Smokeless Tobacco Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00218270
• Other study ID #: NIDA-14404-2
• Secondary ID: R01-14404-2DPMC
• Status: Completed
• Phase: Phase 2
• First received: September 16, 2005
• Last updated: January 9, 2017
• Start date: December 2002
• Est. completion date: May 2005

Study information

• Verified date: June 2008
• Source: National Institute on Drug Abuse (NIDA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tobacco Use Disorder

Intervention

Drug:
• Tobacco free snuff
Tobacco free snuff

Locations

Country	Name	City	State
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent reduction in use		Week 8, 12, and 26	No
Primary	Toxicity profile of carcinogen metabolites		Week 8, 12, and 26	No
Primary	Number of unsuccessful quit attempts		Week 8, 12, and 26	No
Primary	Abstinence (measured at Weeks 8, 12, and 26)		Week 8, 12, and 26	No
Secondary	Motivation and self-efficacy (measured at Weeks 8, 12, and 26)		Week 8, 12, and 26	No