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Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Smokeless Tobacco Cessation

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Trial Information

Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation


The overarching aim of this line of research is to develop effective ST interventions that
can be disseminated. In order to accomplish our aims, the investigators will enroll 1011 ST
users in a multicenter, randomized controlled trial.

The primary aims and hypotheses to be tested in this study are the following:

1. To evaluate the effectiveness of a ST intervention combining the nicotine lozenge and
assisted self-help (LASH) for increasing both prolonged and point prevalence all
tobacco and ST abstinence rates at 6 months follow-up compared to an assisted self-help
intervention (ASH)among ST users who are interested in achieving tobacco abstinence.

Hypothesis: The LASH intervention - adding the lozenge as nicotine replacement
therapy(NRT)- will significantly increase both the prolonged and point prevalence all
tobacco and ST abstinence rates compared to the ASH intervention at 6 months among ST
users who are interested in achieving tobacco abstinence.

2. To evaluate the effectiveness of a ST intervention combining the nicotine lozenge and
assisted self-help (LASH) for increasing both prolonged and point prevalence all
tobacco and ST abstinence rates at 6 months follow-up compared to a lozenge plus
self-help intervention (LSH group: no telephone counseling) among ST users who are
interested in achieving tobacco abstinence.

Hypothesis: The LASH intervention will significantly increase the point prevalence
abstinence rates of all tobacco and ST at 6 months compared to the LSH intervention among ST
users who are interested in achieving tobacco abstinence.

Secondary aims to be tested in this study:

1. To evaluate the incremental cost-per-quit of adding the nicotine lozenge to an assisted
self-help intervention (or of adding an assisted self-help intervention to a nicotine
lozenge intervention)for increasing tobacco abstinence rates.

2. To evaluate changes in self-efficacy and other theoretically-relevant measures related
to the use of the nicotine lozenge as potential mediators of tobacco abstinence.

The investigators will also examine an exploratory aim:

1. To evaluate the relationship between the nicotine metabolite ratio (i.e., ratio of
trans-3'-hydroxycotinine to cotinine) and the number of lozenges used and and ST abstinence
among ST users receiving the nicotine lozenge in the LASH intervention.


Inclusion Criteria:



- 18 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

Exclusion Criteria:

- 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)

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Prolonged All Tobacco Abstinence

Outcome Description:

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

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Herbert H Severson, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oregon Research Institute

Authority:

United States: Institutional Review Board

Study ID:

R01CA142952

NCT ID:

NCT01341938

Start Date:

July 2011

Completion Date:

June 2014

Related Keywords:

  • Smokeless Tobacco Cessation
  • Smokeless Tobacco Use

Name

Location

Oregon Research InsitituteEugene, Oregon  97403