NCT00392379

Brief Summary

This study will be a randomized, blinded, placebo-controlled two-group clinical trial. The independent variable is treatment assignment (active 4-mg nicotine lozenge vs. matching placebo lozenge), and the dependent variables are all tobacco and ST abstinence at 3 and 6 months. ST users will be randomly assigned to either the 4-mg active nicotine lozenge or matching placebo.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

2 active sites

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

October 24, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 26, 2006

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

August 30, 2010

Completed
Last Updated

April 24, 2013

Status Verified

April 1, 2013

Enrollment Period

2.2 years

First QC Date

October 24, 2006

Results QC Date

June 2, 2010

Last Update Submit

April 16, 2013

Conditions

Smokeless Tobacco Use

Keywords

Tobacco use disorderTobacco cessation

Outcome Measures

Primary Outcomes (1)

  • Prolonged Smokeless Tobacco Abstinence at 3 Months

    Participants had to have self-reported not having used any tobacco from two weeks past the target quit date to the 3-months post baseline.

    3 months

Secondary Outcomes (2)

  • Self-reported Point Prevalence All Tobacco Abstinence at 3 Months

    3 months

  • Prolonged Smokeless Tobacco Abstinence at 6 Months

    6 months

Study Arms (2)

A

EXPERIMENTAL

4 mg nicotine lozenges for 3 months

Drug: Nicotine Lozenges

B

PLACEBO COMPARATOR

Placebo nicotine lozenges for 3 months

Drug: Placebo lozenge

Interventions

Nicotine LozengesDRUG

Nicotine lozenges, 4 mg

Also known as: Commit nicotine lozenge
A
Placebo lozengeDRUG

Placebo lozenge

B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • are at least 18 years of age;
  • report smokeless tobacco (ST) as their primary tobacco of use;
  • have used ST daily for the past 6 months;
  • are in general good health (determined by medical history and screening physical examination);
  • have been provided with, understand, and have signed the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

MeSH Terms

Conditions

Tobacco Use DisorderTobacco Use Cessation

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Jon O. Ebbert, MD
Organization
Mayo Clinic
nicotineresearch@mayo.edu
507-266-1944

Study Officials

  • Jon O. Ebbert, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
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
Professor of Medicine

Study Record Dates

First Submitted

October 24, 2006

First Posted

October 26, 2006

Study Start

January 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

April 24, 2013

Results First Posted

August 30, 2010

Record last verified: 2013-04

Locations

US(2)