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Completed

NCT Number: NCT00710034

Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

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.

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Key information

Conditions

Tobacco Use Disorder Behavior Chemically-Induced Disorders Harm Reduction Mental Disorders Substance-Related Disorders

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Minnesota, Minneapolis, Minnesota, United States

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About this study

This second study under "Oral Tobacco as a Harm Reduction Product" grant is a clinical trial. Subjects will be randomized to the brand of smokeless tobacco that is determined to be most effective in Study 1 or to nicotine gum for 12 weeks to compare complete substitution for smoking. The secondary aims are to determine the effects of the products on biomarkers of exposure and toxicity. Other secondary aim includes examining the effects of the two products on withdrawal symptoms. Two sites will be used for these studies: University of Minnesota and Oregon Research Institute (ORI).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • smoking at least 10 cigarettes daily for the past year,
  • in good physical health (no unstable medical condition;
  • no contraindications for medicinal nicotine, as appropriate for the study, stable, good mental health (e.g., no recent unstable or untreated psychiatric diagnosis, including substance abuse, as determined by the DSM-IV criteria).

Exclusion criteria

Subjects must not be currently using other tobacco or nicotine products; Female subjects cannot be pregnant or nursing.

Treatment and study plan

Oral tobacco

Other

Snus

Other names: Camel Snus

Nicotine gum

Drug

4 mg Nicotine gum

Other names: Nicorette

Primary outcomes

  1. Product Effect on Complete Substitution for Smoking

    Time frame: 6 week post smoking substitution

    Number of subjects using only the assigned study product at week 6

  2. Number of Cigarettes Smoked

    Time frame: 6 weeks post cigarette substitution

    Cigarettes per day at mid intervention

  3. Number of Products Used

    Time frame: 6 weeks post smoking substitution

    Pieces of product per week at mid intervention

Secondary outcomes

  1. Products Effect on Withdrawal Symptoms.

    Time frame: Week 1-12 post switching

    Total withdrawal score on the Minnesota Nicotine Withdrawal Scale for subjects using only their assigned study product. This scale measures withdrawal symptoms from cigarettes. There are 8 items on the scale with scores that range from 0 to 4. Total score is calculated by summing the scores (excluding the craving item). Minimum score is 0 and maximum is 28. The higher the score the more severe the withdrawal.

  2. Product Effect on Biomarkers of Exposure and Toxicity

    Time frame: Baseline and Week 4 post smoking substitution

    Total NNAL (e.g., 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol and its glucuronides) among those subjects who reported use of assigned product only (baseline and week 4 samples).

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Oral Tobacco as a Harm Reduction Product: Study 2 - Efficacy of Oral Tobacco Products Compared to Medicinal Nicotine for Complete Cigarette Substitution and Among Non-abstainers, for Reduction in Cigarette Smoking

Important dates

Study start
2010
Primary completion
2013
Study completion
2014
First posted
Jul 3, 2008
Registry last updated
Dec 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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