Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation (LASH)

This study has been completed.
Sponsor:
Collaborators:
Mayo Clinic
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT01341938
First received: April 25, 2011
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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

Hypothesis: The Lozenge Assisted Self-help intervention will significantly increase both the prolonged and point prevalence for all tobacco and smokeless tobacco (ST) abstinence rates at 6 months among ST users who are interested in achieving tobacco abstinence, compared to those in the Assisted Self-Help intervention and the Lozenge Self Help intervention.


Condition Intervention Phase
Smokeless Tobacco Cessation
Drug: Commit® nicotine lozenges (4 mg).
Behavioral: Phone Counseling
Behavioral: Self-help materials
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation

Resource links provided by NLM:


Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:
  • Prolonged All Tobacco Abstinence [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The primary outcome measure will be self-reported prolonged abstinence from all tobacco use at 3- and 6-month follow-up.


Secondary Outcome Measures:
  • Saliva Test for Bio-chemical verification [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    An exploratory test of liver enzyme activity on the metabolism of nicotine will be tested as a potential moderator for the efficacy of the nicotine lozenge.


Enrollment: 1067
Study Start Date: July 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LASH: Nicotine Lozenge, Counseling, Self-help Drug: Commit® nicotine lozenges (4 mg).
Participants will be provided with instructions on the proper use of the lozenge and 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.
Behavioral: Phone Counseling
Three phone counseling sessions to assist in cessation from use of all tobacco.
Behavioral: Self-help materials
Participants receive the "Enough Snuff" video and printed guide providing strategies for tobacco cessation.
Experimental: LSH: Nicotine Lozenge, Self Help Drug: Commit® nicotine lozenges (4 mg).
Participants will be provided with instructions on the proper use of the lozenge and 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.
Behavioral: Self-help materials
Participants receive the "Enough Snuff" video and printed guide providing strategies for tobacco cessation.
Experimental: ASH: Counseling, Self Help Behavioral: Phone Counseling
Three phone counseling sessions to assist in cessation from use of all tobacco.
Behavioral: Self-help materials
Participants receive the "Enough Snuff" video and printed guide providing strategies for tobacco cessation.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01341938

Locations
United States, Oregon
Oregon Research Insititute
Eugene, Oregon, United States, 97403
Sponsors and Collaborators
Oregon Research Institute
Mayo Clinic
Investigators
Principal Investigator: Herbert H Severson, PhD Oregon Research Institute
  More Information

No publications provided

Responsible Party: Oregon Research Institute
ClinicalTrials.gov Identifier: NCT01341938     History of Changes
Other Study ID Numbers: R01CA142952, R01CA142952-01
Study First Received: April 25, 2011
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Oregon Research Institute:
Smokeless Tobacco Use

Additional relevant MeSH terms:
Lobeline
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 01, 2014