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Human Laboratory Study of Smokeless Tobacco Products

NCT01100216 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2014-12-10

No results posted yet for this study

Summary

With the advent of restrictions on public smoking, the tobacco industry has introduced a variety of novel smokeless tobacco products (NSTP) to allow continued tobacco use. These products typically have lower tobacco-specific nitrosamines, carcinogens and nicotine than conventional smokeless products out on the market. No studies have compared the effects of NSTP and medicinal nicotine products (MNP) in smokeless tobacco users and whether some of the NSTP products may serve as a cessation tool for smokeless tobacco users. Our hypothesis is that the effects from these products will be directly related to their nicotine content and sensory effects. Products that produce greater effects on outcome measures may serve as potential cessation tools.

Conditions

  • Smokeless Tobacco

Interventions

OTHER

Nicotine Lozenge

4 mg for 12 days

OTHER

Stonewall Dissolvable Tobacco Pieces

5.6 mg nicotine pieces for 12 days

OTHER

Camel Snus Frost

pouches, 6.2 mg nicotine, for 12 days

OTHER

Skoal Wintergreen

Used at baseline (Days 1 and 2, 5-11) and then at every 7 day wash-out period.

Sponsors & Collaborators

Principal Investigators

  • Marc Mooney, Ph.D. · Dept. Psychiatry, University of Minnesota

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-03-31
Primary Completion
2010-12-31
Completion
2010-12-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT01100216 on ClinicalTrials.gov