Phase 2 N=391 Randomized Treatment

Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

Tobacco Use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT00710034 ↗

Enrolled (actual)

391

Serious AEs

0.5%

Results posted

Dec 2017

Primary outcome: Primary: Product Effect on Complete Substitution for Smoking — 56; 56 participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Oral tobacco (Other); Nicotine Gum (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Minnesota
Primary completion: May 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Product Effect on Complete Substitution for Smoking	56; 56	—
PRIMARY Number of Cigarettes Smoked	18.6; 18.8	—
PRIMARY Number of Products Used	37.6; 39.1	—
SECONDARY Products Effect on Withdrawal Symptoms.	4.17; 5.01; 5.57; 5.73	—
SECONDARY Product Effect on Biomarkers of Exposure and Toxicity	1.39; 1.28; 0.30; 1.34	—

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.

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.

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Data sourced from ClinicalTrials.gov (NCT00710034). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.