NCT00939029

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jul 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 10, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 14, 2009

Completed
12 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
11 months until next milestone

Results Posted

Study results publicly available

April 25, 2014

Completed
Last Updated

May 19, 2014

Status Verified

May 1, 2014

Enrollment Period

2.9 years

First QC Date

July 10, 2009

Results QC Date

March 25, 2014

Last Update Submit

May 8, 2014

Conditions

Smokeless Tobacco Use

Keywords

tobacco usesmokeless tobaccochewing tobaccosnuffnicotine replacementtobacco dependencetobacco cessationtobacco abstinence

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Point-prevalence Abstinence at 3 Months

    week 12

  • Point-prevalence Abstinence at 6 Months

    week 24

Study Arms (2)

Active

ACTIVE COMPARATOR

2 nicotine patches each at 21 mg/day for a total of 42 mg/day for 8 weeks

Drug: nicotine replacement therapy (nicotine patches)

placebo

PLACEBO COMPARATOR

2 patches (containing non active ingredients) per day for 8 weeks

Drug: placebo NRT

Interventions

nicotine replacement therapy (nicotine patches)DRUG

2- 21 mg patches per day for 8 weeks

Active
placebo NRTDRUG

2 placebo patches (containing no active ingredient)per day for 8 weeks

placebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related 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.

    PMID: 23873976RESULT

MeSH Terms

Conditions

Tobacco UseTobacco Use DisorderTobacco Use Cessation

Interventions

Nicotine Replacement TherapyTobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

BehaviorSubstance-Related DisordersChemically-Induced DisordersMental DisordersHealth Behavior

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Results Point of Contact

Title
Dr. Jon Ebbert
Organization
Mayo Clinic
ebbert.jon@mayo.edu
507-284-4736

Study Officials

  • Jon O Ebbert, MD

    Mayo Clinic

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priniciple Investigator

Study Record Dates

First Submitted

July 10, 2009

First Posted

July 14, 2009

Study Start

July 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

May 19, 2014

Results First Posted

April 25, 2014

Record last verified: 2014-05

Locations

US(1)