Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use

NCT ID: NCT00218296

Last Updated: 2017-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 332 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2009-01-31

Brief Summary

Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has health risks associated with its use. While treatment programs that focus on stopping tobacco use may be effective, past research has shown that interventions that specifically focus on reducing tobacco use may be equally effective and may motivate individuals to eventually quit using tobacco. This study will compare the effectiveness of a ST reduction treatment program versus a usual tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.

Detailed Description

Individuals who use ST are at increased risk for cancer or dying from cardiovascular disease. Other long-term effects include tooth abrasion, gum recession, and loss of bone in the jaw. Many individuals who use ST recognize the health risks associated with ST, but either do not want to quit or feel that it is impossible to quit. For these individuals, tobacco reduction may be an important transitional goal, either prior to quitting or as a treatment endpoint. By participating in a tobacco reduction program, these individuals may be motivated to eventually stop using tobacco altogether. The purpose of this study is to compare a ST reduction treatment program versus a standard tobacco cessation treatment program (immediate cessation) for reducing tobacco use in ST users.

This study will enroll regular users of ST. Participants will be randomly assigned to either a tobacco reduction program or to usual care, a standard tobacco cessation program during the first telephone contact. At the first clinic visit, participants assigned to the tobacco Reduction Group will replace their usual brand of ST with one of two options: an ST brand with less nicotine or nicotine lozenge. Participants will be encouraged to reduce their nicotine intake by at least 50% the first two weeks and encouraged to further reduce their nicotine intake in the following 4 weeks. Participants assigned to the Usual Care Group will be advised to quit and will be asked to set a quit date within two weeks. Telephone counseling, ideas on methods for sustaining cessation, and a self-help manual will also be provided along with a 2 week supply of nicotine patches. Study visits will occur at 2, 4, 8, 12, 26, and 32 (for reduction group) weeks. Outcome assessments will include vital signs, physiological measures related to tobacco use, levels of nicotine reduction, tobacco use status, and measures of motivation and self-efficacy to quit.

Conditions

Tobacco Use Disorder

Keywords

Nicotine Dependence; Tobacco Dependence

Study Design

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

Study Groups

Usual Care Group

Usual care for cessation with immediate quit date scheduled and two weeks of nicotine patch supplied.

Group Type: ACTIVE_COMPARATOR

Usual Care Group

Intervention Type: DRUG

Nicotine replacement therapy

Reduction Group

Reduction in nicotine exposure for 6 weeks prior to quit date using medicinal nicotine lozenge or reduced nicotine smokeless tobacco.

Group Type: EXPERIMENTAL

Reduction Group

Intervention Type: OTHER

Subject selects preferred method for reduction.

Interventions

Usual Care Group

Nicotine replacement therapy

Intervention Type: DRUG

Reduction Group

Subject selects preferred method for reduction.

Intervention Type: OTHER

Other Intervention Names

21 mg Nicotine Patch; Nicoderm; Commit Nicotine Lozenge or; Reduced nicotine smokeless tobacco products (Skoal, Skoal Bandits)

Eligibility Criteria

Inclusion Criteria

• No interest in stopping ST use within 90 days of study entry
• Daily use of ST in the 6 months prior to study entry

Exclusion Criteria

• Current use of tobacco or nicotine products, other than ST
• Current unstable medical and mental health conditions
• Use of any medication that may affect tobacco use or be affected by a reduction in tobacco use
• Pregnant or breastfeeding

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dorothy Hatsukami, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Univerisity of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

References

Schiller KR, Luo X, Anderson AJ, Jensen JA, Allen SS, Hatsukami DK. Comparing an immediate cessation versus reduction approach to smokeless tobacco cessation. Nicotine Tob Res. 2012 Aug;14(8):902-9. doi: 10.1093/ntr/ntr302. Epub 2012 Jan 4.

Reference Type: RESULT

PMID: 22218402 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed/22218402

Schiller KR, Luo X, Anderson AJ, Jensen JA, Allen SS, Hatsukami DK. Comparing an immediate cessation versus reduction approach to smokeless tobacco cessation. Nicotine Tob Res 2012.

Other Identifiers

R01-DA14404-4

Identifier Type: -

Identifier Source: secondary_id

DPMCDA

Identifier Type: -

Identifier Source: secondary_id

R01DA014404

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NIDA-14404-4

Identifier Type: -

Identifier Source: org_study_id