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Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

NCT00710034 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 391

Last updated 2017-12-06

Study results available
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Summary

For the primary goals, we hypothesize that 1) the oral tobacco product will be more efficacious than the medicinal nicotine product in substituting for smoking cigarettes; 2) among non-abstainers, the oral tobacco product will lead to greater reduction in cigarette smoking than medicinal nicotine; and 3) a higher rate of oral tobacco compared to medicinal nicotine use will be observed during and beyond the treatment period.

For the secondary goals, we hypothesize that 1) both products will equally reduce withdrawal symptoms from cigarette abstinence; and 2) the toxicant exposure and toxicity will be reduced dramatically when smokers switch from cigarettes to each of these products; however, this reduction will be greater with the use of medicinal nicotine.

Conditions

  • Tobacco Use Disorder

Interventions

OTHER

Oral tobacco

Snus

DRUG

Nicotine Gum

4 mg Nicotine gum

Sponsors & Collaborators

Principal Investigators

  • Dorothy Hatsukami, Ph.D. · University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-05-31
Completion
2014-05-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00710034 on ClinicalTrials.gov