Phase 3 N=52 Randomized Quadruple-blind Treatment

Highdose Nicotine Patch Therapy for Smokeless Tobacco Use

Smokeless Tobacco Use

Bottom Line

View on ClinicalTrials.gov: NCT00939029 ↗

Enrolled (actual)

Serious AEs

1.9%

Results posted

Apr 2014

Primary outcome: Primary: End of Treatment (Week 8) Point Prevalence Abstinence — 11; 6 participants — p=0.05

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: nicotine replacement therapy (nicotine patches) (Drug); placebo NRT (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Mayo Clinic
Primary completion: Jun 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY End of Treatment (Week 8) Point Prevalence Abstinence	11; 6	0.05
SECONDARY Point-prevalence Abstinence at 3 Months	12; 5	0.014 sig
SECONDARY Point-prevalence Abstinence at 6 Months	11; 7	0.087

Summary

Smokeless tobacco use ("chewing") is associated with negative health effects. To date, no medications have been shown to help chewers quit long-term. High dose nicotine patch therapy may improve the chances that chewers can quit for good. If found to be effective, chewers may use this treatment to help them quit and reduce their risk for negative health effects.

Eligibility Criteria

Inclusion Criteria

are at least 18 years of age and at most 55 years of age;
report daily ST use for the past 12 months;
identify ST as their primary tobacco product;
use an average of ≥ 3 cans/pouches per week;
are in general good health (determined by medical history and screening physical examination);
have been provided with, understand, and have signed the informed consent.

Exclusion Criteria

are currently using (past 30 days) any other behavioral or pharmacologic tobacco treatment program;
are currently pregnant or lactating;
have had unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months;
have a history of arrhythmia or an abnormal tracing on the baseline EKG;
have a blood pressure of greater than 140/90 or a pulse of more than 110 beats per minute;
have a history of severe skin allergies or dermatoses;
have a history of intolerance to nicotine patches;
have another member of their household already participating in this study;
are taking a medication known to interact with nicotine (i.e., clozapine);
are taking any prescription medication for depression or asthma

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00939029). 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.