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A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01509586
First received: December 14, 2011
Last updated: January 10, 2012
Last verified: December 2011
History of Changes
  Purpose

This nationwide telephone and mail- based research study will recruit 1,400 cigarette smokers who are not motivated to quit to test the effects of a marketed oral, non-combustible smokeless tobacco product on cigarette smoking behaviors. It will also track the participants' usage patterns of the smokeless tobacco product.

Half of the participants will receive a new, potentially safer tobacco product during the first six weeks of the study, and half will not. During this six-week period, each participant will complete three brief phone interviews. After this first six week period, participants will complete 6 other brief follow-up interviews, where they will answer questionnaires about their smoking habits.


Condition Intervention
Smoking
Smoking Cessation
 Drug: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Test of Short and Long Term Naturalistic Outcomes of Smokers Who Sample Smokeless Tobacco

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Prevalence of smokeless tobacco product use in the smokeless tobacco group [ Time Frame: From study enrollment through end of one-year follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in smoking behavior [ Time Frame: From study enrollment through end of one-year follow up ] [ Designated as safety issue: No ]
    We will determine changes in each of the following outcomes: 1) cigarette smoking, 2) motivation to quit, 3) confidence to quit. Cigarette smoking will be determined as the average cigarettes per day over the prior 7 days. Change in each outcome will be measured at 3 timepoints, each measured as change since baseline: a) end of tobacco product sampling period, b) 6-month, and c) 12-month follow-up.


Estimated Enrollment: 1400
Study Start Date: November 2011
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PREP (Potentially Reduced Exposure Product) Group Drug: Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product
The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
No Intervention: cigarette group

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age >=19
  • a daily cigarette smoker of >=10 cigs/day
  • English speaking
  • live in the contiguous U.S.
  • unmotivated to quit smoking in the next 30 days

Exclusion Criteria:

  • no use of smokeless tobacco in past six months
  • not breastfeeding, pregnant, or planning a pregnancy
  • devoid of any recent (past 6 months) cardiovascular trauma
  • no quit attempt of >=1 week in past 6 months
  • no use of pharmacotherapy to quit smoking in past 3 months
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509586

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
National Cancer Institute (NCI)
Investigators
Principal Investigator: Matthew J. Carpenter, Ph.D. Medical University of South Carolina
  More Information

No publications provided

Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01509586     History of Changes
Other Study ID Numbers: Pro00007428, R01CA154992
Study First Received: December 14, 2011
Last Updated: January 10, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
smoking
smoking cessation
Potentially Reduced Exposure Products (PREPs)

Additional relevant MeSH terms:
Smoking
Habits
Lobeline
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013