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

NCT00218244 | Completed Phase 1 DMC

• 3 other identifiers: NIDA-14404-1R01-14404-1DPMC
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder

Keywords

Brand Switching, smokeless tobacco use

Outcome Measures

Primary Outcomes (4)

• Percent reduction in ST use

  26 weeks

• Toxicity profile of carcinogen metabolites

  26 weeks

• Number of unsuccessful quit attempts

  26 weeks

• Abstinence from ST use (measured at Week 8, and 12 and 26 weeks following treatment completion)

  26 weeks

Secondary Outcomes (1)

• Motivation and self-efficacy (measured at Week 8, and 12 and 26 weeks following treatment completion)

  26 weeks

Study Arms (3)

1 Controlled use

ACTIVE COMPARATOR

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

Other: Lower Nicotine Smokeless Tobacco Product

2 Uncontrolled use

ACTIVE COMPARATOR

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

Other: Lower Nicotine Smokeless Tobacco Product

3 Behavioral

PLACEBO COMPARATOR

Reduction in smokeless tobacco use using behavioral techniques only.

Other: Behavioral Counseling

Interventions

Lower Nicotine Smokeless Tobacco Product OTHER

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

Also known as: Skoal and Skoal Bandits

1 Controlled use; 2 Uncontrolled use

Behavioral Counseling OTHER

Behavioral counseling alone for reduction in tobacco use.

3 Behavioral

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Drug Abuse (NIDA): lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dorothy Hatsukami, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: August 1, 2001
• Primary Completion: November 1, 2004
• Study Completion: November 1, 2004
• Last Updated: January 10, 2017

Record last verified: 2008-06

Locations

US (1)