Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine

Completed · Phase 2

Conditions studied: Tobacco Use Disorder

In brief

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.

Key facts

Study ID

NCT00710034

Run by

University of Minnesota

People needed

391

Starts

2010-04-01

Expected to finish

2014-05-01

Last updated by the study team

2017-12-06

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

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

Where it is running

• University of Minnesota — Minneapolis, Minnesota, United States
• Oregon Research Institute — Eugene, Oregon, United States

Full record on ClinicalTrials.gov

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