Highdose Nicotine Patch Therapy for Smokeless Tobacco Use

Smokeless Tobacco Use Clinical Trial

Official title:

Highdose Nicotine Patch Therapy for Smokeless Tobacco Use

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00939029
• Other study ID #: 09-002581
• Secondary ID: CA14012509-00176
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 10, 2009
• Last updated: May 8, 2014
• Start date: July 2010
• Est. completion date: June 2013

Study information

• Verified date: May 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

Approximately 8.2 million (3.3%) of Americans ≥ 12 years of age are current smokeless tobacco (ST) users, and the prevalence of ST use has increased over the past three years. ST is increasingly being promoted as a harm reduction strategy for cigarette smoking, and two of the world's largest cigarette manufacturers have entered the ST market. ST use is estimated to be the greatest exogenous source of human exposure to cancer-causing nitrosamines. ST has been associated with oral and extra-oral cancer as well as cardiovascular and cerebrovascular mortality.

A need for efficacious interventions exists as 64% of ST users report the desire to quit. However, no pharmacotherapy has proven efficacy for increasing long-term (> 6 months) tobacco abstinence rates among ST users compared to placebo. New pharmacotherapies, drug combinations, and improved dosing of existing pharmacotherapies are needed. Previous research with nicotine patches for ST users using standard doses (up to 21 mg/day) have not increased long-term abstinence rates. However, studies of higher dose nicotine patch therapy (up to 63 mg/day) in ST users have demonstrated a dose-dependent reduction in tobacco withdrawal symptoms as well as preliminary evidence of increased long-term (> 6 months) abstinence rates compared to lower doses. The purpose of this study is to evaluate the efficacy of high dose nicotine patch therapy (42 mg/day) for increasing the 7-day point prevalence and prolonged all tobacco and ST abstinence rates at end-of-treatment (week 8), 12 and 24 weeks compared to placebo in ST users who use ≥ 3 cans/pouches per week when all subjects receive behavioral treatment for tobacco dependence. To accomplish our aims, we will randomize 60 ST users in a clinical pilot study. The work will be conducted at the Mayo Clinic in Rochester, MN.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. are at least 18 years of age and at most 55 years of age;

2. report daily ST use for the past 12 months;

3. identify ST as their primary tobacco product;

4. use an average of = 3 cans/pouches per week;

5. are in general good health (determined by medical history and screening physical examination);

6. have been provided with, understand, and have signed the informed consent.

Exclusion Criteria:

1. are currently using (past 30 days) any other behavioral or pharmacologic tobacco treatment program;

2. are currently pregnant or lactating;

3. have had unstable angina, myocardial infarction, or coronary angioplasty within the past 3 months;

4. have a history of arrhythmia or an abnormal tracing on the baseline EKG;

5. have a blood pressure of greater than 140/90 or a pulse of more than 110 beats per minute;

6. have a history of severe skin allergies or dermatoses;

7. have a history of intolerance to nicotine patches;

8. have another member of their household already participating in this study;

9. are taking a medication known to interact with nicotine (i.e., clozapine);

10. are taking any prescription medication for depression or asthma

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Smokeless Tobacco Use

Intervention

Drug:
• nicotine replacement therapy (nicotine patches)
2- 21 mg patches per day for 8 weeks
• placebo NRT
2 placebo patches (containing no active ingredient)per day for 8 weeks

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

Ebbert JO, Croghan IT, Schroeder DR, Hurt RD. A randomized phase II clinical trial of high-dose nicotine patch therapy for smokeless tobacco users. Nicotine Tob Res. 2013 Dec;15(12):2037-44. doi: 10.1093/ntr/ntt097. Epub 2013 Jul 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	End of Treatment (Week 8) Point Prevalence Abstinence	7 day point prevalence abstinence at the end of treatment, biochemically confirmed by urinary anabasine < 2 ng per ml	weeks 8	No
Secondary	Point-prevalence Abstinence at 3 Months	7 day point prevalence abstinence from tobacco at 3 months, biochemically confirmed using urinary anabasine < 2 ng per ml	week 12	No
Secondary	Point-prevalence Abstinence at 6 Months	7 day point prevalence abstinence from all tobacco at 6 months, biochemically confirmed using urinary anabasine < 2 ng per ml.	week 24	No