NCT01341938

Brief Summary

This research study will determine if using a combination of 4-mg nicotine lozenges, self-help materials, and/or telephone tobacco cessation counseling will help smokeless tobacco users stop using tobacco. The study will consist of three interventions:

  1. 1.The Lozenge Assisted Self-help intervention - lozenge nicotine replacement therapy, phone counseling, and self help materials
  2. 2.Assisted Self-Help intervention - self-help materials and phone counseling without lozenges
  3. 3.Lozenge Self Help intervention - self help materials and lozenge nicotine replacement therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,067

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2011

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

April 25, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 26, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

August 4, 2021

Status Verified

July 1, 2021

Enrollment Period

1.3 years

First QC Date

April 25, 2011

Last Update Submit

July 28, 2021

Conditions

Smokeless Tobacco Cessation

Keywords

Smokeless Tobacco Use

Outcome Measures

Primary Outcomes (1)

  • Prolonged All Tobacco Abstinence

    The primary outcome measure will be self-reported prolonged abstinence from all tobacco use at 3- and 6-month follow-up.

    6 months

Secondary Outcomes (1)

  • Saliva Test for Bio-chemical Verification of Tobacco Abstinence

    6 months

Study Arms (3)

Lozenge Self Help: self help materials & lozenge NRT.

ACTIVE COMPARATOR

Self-help materials + Commit® nicotine lozenges (4 mg)

Drug: Commit® nicotine lozenges (4 mg) & self-help materialsBehavioral: Phone counseling & self-help materials

Lozenge Assisted Self-help: lozenge NRT, phone counseling, & self help materials

EXPERIMENTAL

Self-help materials + Commit® nicotine lozenges (4 mg) + Phone counseling

Drug: Commit® nicotine lozenges (4 mg) & self-help materialsBehavioral: Commit® nicotine lozenges (4 mg) & phone counseling & self-help materialsBehavioral: Phone counseling & self-help materials

Assisted Self-Help: self-help materials & phone counseling without lozenges

EXPERIMENTAL

Self-help materials + Phone counseling

Behavioral: Commit® nicotine lozenges (4 mg) & phone counseling & self-help materialsBehavioral: Phone counseling & self-help materials

Interventions

Commit® nicotine lozenges (4 mg) & self-help materialsDRUG

Participants provided with instructions on standard use of lozenge for nicotine replacement therapy (NRT) \& instructed to use the lozenge any time they have a craving or urge to use ST or tobacco. Dosing: weeks 1-6 one lozenge every 1-2 hours/16 per day, weeks 7-9 one lozenge every 2-4 hours/8 per day, weeks 10-12 one lozenge every 4-8 hours/4 per day + The "Enough Snuff" video and printed guide providing strategies for tobacco cessation.

Also known as: Active Comparator, Lonzenge + self-help only
Lozenge Assisted Self-help: lozenge NRT, phone counseling, & self help materialsLozenge Self Help: self help materials & lozenge NRT.
Commit® nicotine lozenges (4 mg) & phone counseling & self-help materialsBEHAVIORAL

Three phone counseling sessions to assist in cessation from use of all tobacco + lozenge nicotine replacement therapy (NRT) + The "Enough Snuff" video and printed guide providing strategies for tobacco cessation.

Also known as: lonzenge + phone + self-help
Assisted Self-Help: self-help materials & phone counseling without lozengesLozenge Assisted Self-help: lozenge NRT, phone counseling, & self help materials
Phone counseling & self-help materialsBEHAVIORAL

Three phone counseling sessions to assist in cessation from use of all tobacco + The "Enough Snuff" video and printed guide providing strategies for tobacco cessation.

Also known as: phone + self-help only
Assisted Self-Help: self-help materials & phone counseling without lozengesLozenge Assisted Self-help: lozenge NRT, phone counseling, & self help materialsLozenge Self Help: self help materials & lozenge NRT.

Eligibility Criteria

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

You may qualify if:

  • years old or over
  • Currently using smokeless tobacco products as primary tobacco product
  • Use smokeless tobacco for the last 6 months
  • Currently want to quit
  • Able to read and write English; and
  • Willing to share phone number, e-mail, and mailing address with the research project
  • complete informed consent process

You may not qualify if:

  • have used behavioral or pharmacologic tobacco treatment in last 30 days
  • medical history of unstable angina, myocardial infarction within the past 6 months, cardiac dysrhythmia other than medication-controlled atrial fibrillation or PSVT or medically treated or untreated hypertension with BP ≥ 180 systolic OR ≥ 100 diastolic
  • have phenylketonuria (PKU)
  • have another member of their household already participating in this study
  • currently pregnant or nursing
  • score of ≥ 15 on the Patient Health Questionnaire (PHQ-8)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Insititute

Eugene, Oregon, 97403, United States

Location

Related Publications (2)

  • Ebbert JO, Severson HH, Danaher BG, Benowitz NL, Schroeder DR. Nicotine Metabolite Ratio Is Associated With Lozenge Use But Not Quitting in Smokeless Tobacco Users. Nicotine Tob Res. 2016 Mar;18(3):366-70. doi: 10.1093/ntr/ntv102. Epub 2015 May 14.

    PMID: 25977408RESULT

  • Severson HH, Danaher BG, Ebbert JO, van Meter N, Lichtenstein E, Widdop C, Crowley R, Akers L, Seeley JR. Randomized trial of nicotine lozenges and phone counseling for smokeless tobacco cessation. Nicotine Tob Res. 2015 Mar;17(3):309-15. doi: 10.1093/ntr/ntu145. Epub 2014 Aug 28.

    PMID: 25168034RESULT

MeSH Terms

Conditions

Tobacco Use Cessation

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • Herbert H Severson, PhD

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 25, 2011

First Posted

April 26, 2011

Study Start

July 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

August 4, 2021

Record last verified: 2021-07

Locations

US(1)