Clinical trial NCT00710034: Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Tobacco Use Disorder
Keywords: Oral Tobacco Products
Snus
Smoking Substitution
Harm Reduction
Biomarkers of Tobacco Exposure
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-07-03
Enrollment: 391
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Product Effect on Complete Substitution for Smoking
timeFrame: 6 week post smoking substitution
measure: Number of Cigarettes Smoked
timeFrame: 6 weeks post cigarette substitution
measure: Number of Products Used
timeFrame: 6 weeks post smoking substitution
Secondary outcomes:
measure: Products Effect on Withdrawal Symptoms.
timeFrame: Week 1-12 post switching
measure: Product Effect on Biomarkers of Exposure and Toxicity
timeFrame: Baseline and Week 4 post smoking substitution
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
affiliation: University of Minnesota
name: Dorothy Hatsukami, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hatsukami DK, Severson H, Anderson A, Vogel RI, Jensen J, Broadbent B, Murphy SE, Carmella S, Hecht SS. Randomised clinical trial of snus versus medicinal nicotine among smokers interested in product switching. Tob Control. 2016 May;25(3):267-74. doi: 10.1136/tobaccocontrol-2014-052080. Epub 2015 May 19.