Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

University of Minnesota391 enrolled

Overview

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.

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

391

Conditions

Tobacco Use Disorder

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Product Effect on Complete Substitution for Smoking

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

Time frame: 6 week post smoking substitution

Number of Cigarettes Smoked

Cigarettes per day at mid intervention

Time frame: 6 weeks post cigarette substitution

Number of Products Used

Pieces of product per week at mid intervention

Time frame: 6 weeks post smoking substitution

Secondary Outcomes

Products Effect on Withdrawal Symptoms.

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.

Time frame: Week 1-12 post switching

Product Effect on Biomarkers of Exposure and Toxicity

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).

Time frame: Baseline and Week 4 post smoking substitution