Phase 2
Completed N=391
Efficacy of Oral Tobacco Products Compared to a Medicinal Nicotine
Source: ClinicalTrials.gov NCT00710034 ↗Enrolled (actual)
391
Serious AEs
0.5%
Results posted
Dec 2017
Primary outcomePrimary: Product Effect on Complete Substitution for Smoking — 56; 56 participants
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.
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 | — |
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.
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. Informational only — not medical advice.