Comparison Across Treatment Conditions to Reduce Smokeless Tobacco Use

NCT00218296 | Completed Phase 2 Results DMC

• 4 other identifiers: NIDA-14404-4R01-DA14404-4DPMCDAR01DA014404
• Study Type: interventional
• Target: 332
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder

Keywords

Nicotine Dependence; Tobacco Dependence

Outcome Measures

Primary Outcomes (6)

• Percent Abstinent From Tobacco at Week 12 (7 Day Point Prevalence)

  No tobacco use 7 days prior to Week 12 verified by biomarkers (urine, cotinine and CO)

  12 weeks

• Percent Prolonged Abstinence From Tobacco at Week 12

  Continuous tobacco cessation from quit date through Week 12 verified by biomarkers (urine, cotinine and CO)

  12 weeks

• Percent Abstinent From Tobacco at Week 26 (7 Day Point Prevalence)

  Abstinence from tobacco 7 days prior to Week 26 (Assessed at 26 weeks for Usual Care and 20 weeks for Reduction Group post-quit date)

  26 week

• Percent Prolonged Abstinence From Tobacco at Week 26

  Continuous Abstinence from quit date through Week 26 (Assessed at Week 26 for Usual Care and Week 20 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).

  26 weeks

• Percent Abstinent From Tobacco at Week 32 (7 Day Point Prevalence)

  Abstinence from tobacco 7 days prior to Week 26 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group. Reduction Group's quit date is 6 weeks later than Usual Care).

  32 Weeks

• Percent Prolonged Abstinence From Tobacco at Week 32

  Continuous Abstinence from quit date through Week 32 (Assessed at Week 32 for Usual Care and Week 26 for Reduction Group, Reduction Group's quit date is 6 weeks later than Usual Care).

  32 Weeks

Study Arms (2)

Usual Care Group

ACTIVE COMPARATOR

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

Drug: Usual Care Group

Reduction Group

EXPERIMENTAL

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

Other: Reduction Group

Interventions

Usual Care Group DRUG

Nicotine replacement therapy

Also known as: 21 mg Nicotine Patch, Nicoderm

Usual Care Group

Reduction Group OTHER

Subject selects preferred method for reduction.

Also known as: Commit Nicotine Lozenge or, Reduced nicotine smokeless tobacco products (Skoal, Skoal Bandits)

Reduction Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

Univerisity of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

Related Publications (1)

• 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.

  PMID: 22218402 RESULT

Related Links

• 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.

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices; Nicotine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Limitations and Caveats

Sample size was limited.

Results Point of Contact

• Title: Dorothy Hatsukami, Ph.D.
• Organization: University of Minnesota

hatsu001@umn.edu

612-626-2121

Study Officials

• Dorothy Hatsukami, PhD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2005
• First Posted: September 22, 2005
• Study Start: November 1, 2006
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: October 16, 2017
• Results First Posted: December 19, 2013

Record last verified: 2017-09

Locations

US (1)