Effectiveness of Using Tobacco Free Snuff in Reducing Negative Effects of Smokeless Tobacco Use - Full Text View

Sponsor:	National Institute on Drug Abuse (NIDA)
Information provided by:	National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:	NCT00218270

Purpose

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.

Condition	Intervention	Phase
Tobacco Use Disorder	Drug: Tobacco free snuff	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Treatment of Smokeless Tobacco Users

Resource links provided by NLM:

MedlinePlus related topics: Smokeless Tobacco

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:

Percent reduction in use [ Time Frame: Week 8, 12, and 26 ] [ Designated as safety issue: No ]
Toxicity profile of carcinogen metabolites [ Time Frame: Week 8, 12, and 26 ] [ Designated as safety issue: No ]
Number of unsuccessful quit attempts [ Time Frame: Week 8, 12, and 26 ] [ Designated as safety issue: No ]
Abstinence (measured at Weeks 8, 12, and 26) [ Time Frame: Week 8, 12, and 26 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Motivation and self-efficacy (measured at Weeks 8, 12, and 26) [ Time Frame: Week 8, 12, and 26 ] [ Designated as safety issue: No ]

Enrollment:	138
Study Start Date:	December 2002
Study Completion Date:	May 2005
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Reduction of tobacco use by substituting tobacco free snuff.	Drug: Tobacco free snuff Tobacco free snuff Other Name: Smokey Mountain
Placebo Comparator: 2 Reduction of tobacco use by using behavioral techniques.	Drug: Tobacco free snuff Tobacco free snuff Other Name: Smokey Mountain

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.

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00218270

Locations

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

Sponsors and Collaborators

National Institute on Drug Abuse (NIDA)

Investigators

Principal Investigator:

Dorothy Hatsukami, PhD

University of Minnesota - Clinical and Translational Science Institute

More Information

No publications provided

Responsible Party:	Dorohty Hatsukami, UMN
ClinicalTrials.gov Identifier:	NCT00218270 History of Changes
Other Study ID Numbers:	NIDA-14404-2, R01-14404-2, DPMC
Study First Received:	September 16, 2005
Last Updated:	June 27, 2008
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):

Smokeless tobacco, harm reduction

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 May 21, 2012