Using Smokeless Tobacco Products With Lower Nicotine Levels to Reduce Negative Effects of Smokeless Tobacco Use

NCT ID: NCT00218244

Last Updated: 2017-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-08-31
• Study Completion Date: 2004-11-30

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. This study will assess the effectiveness of limiting smokeless tobacco (ST) nicotine intake 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. It affects the cardiovascular system and may be associated with heart disease, stroke, and high blood pressure. Long-term effects of spit tobacco use include tooth abrasion, gum recession, mouth disease, bone loss in the jaw, yellowing of the teeth, and chronic bad breath. 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 limiting ST nicotine intake 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 in this open-label study will be randomly assigned to one of three treatment conditions: switching to an ST brand with less concentrated nicotine and controlling for ST use; switching to an ST brand with less concentrated nicotine, combined with no limit on ST intake; or continued use of usual ST brand with no limit on intake (control group). Participants in both brand-switching conditions will use ST brands that have 50% less nicotine than their usual ST brands for the first 4 weeks. For the next 4 weeks, participants in the brand-switching conditions will use ST brands that have 75% less nicotine that their usual ST brands. Study visits will ocur once weekly during the 8-week treatment period. The number of participants who do not complete treatment, reduce nicotine intake, or quit completely will be assessed at Week 8 and at follow-up visits, which will be held 12 and 26 weeks following the completion of treatment.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 Controlled use

Reduction in tobacco toxicants by switching to a lower nicotine tobacco product under a controlled use condition.

Group Type: ACTIVE_COMPARATOR

Lower Nicotine Smokeless Tobacco Product

Intervention Type: OTHER

Skoal for 50% reduction;Skoal bandits for 75% reduction.

2 Uncontrolled use

Reduction in tobacco toxicants by switching to a lower nicotine tobacco product under an uncontrolled use condition.

Group Type: ACTIVE_COMPARATOR

Lower Nicotine Smokeless Tobacco Product

Intervention Type: OTHER

Skoal for 50% reduction;Skoal bandits for 75% reduction.

3 Behavioral

Reduction in smokeless tobacco use using behavioral techniques only.

Group Type: PLACEBO_COMPARATOR

Behavioral Counseling

Intervention Type: OTHER

Behavioral counseling alone for reduction in tobacco use.

Interventions

Lower Nicotine Smokeless Tobacco Product

Skoal for 50% reduction;Skoal bandits for 75% reduction.

Intervention Type: OTHER

Behavioral Counseling

Behavioral counseling alone for reduction in tobacco use.

Intervention Type: OTHER

Other Intervention Names

Skoal and Skoal Bandits

Eligibility Criteria

Inclusion Criteria

• Not interested in quitting ST use within 90 days of study entry
• Has been using ST at least six times a day for 6 months prior to study entry
• Agrees to use an effective form of contraception throughout the study

Exclusion Criteria

• Current use of other tobacco or nicotine products
• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: lead

Responsible Party

University of Minnesota

Principal Investigators

Dorothy Hatsukami, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

R01-14404-1

Identifier Type: -

Identifier Source: secondary_id

DPMC

Identifier Type: -

Identifier Source: secondary_id

NIDA-14404-1

Identifier Type: -

Identifier Source: org_study_id