Smokeless Tobacco CessationLASHNCT01341938
Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation
A study testing Commit® nicotine lozenges (4 mg) & self-help materials, Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials and Phone counseling & self-help materials in people with Smokeless Tobacco Cessation, run by Oregon Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smokeless Tobacco Cessation
- What is being tested?
- Commit® nicotine lozenges (4 mg) & self-help materials, Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials and Phone counseling & self-help materials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,067 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to Nov 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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:
- The Lozenge Assisted Self-help intervention - lozenge nicotine replacement therapy, phone counseling, and self help materials
- Assisted Self-Help intervention - self-help materials and phone counseling without lozenges
- 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.
Read the 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:
- 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.
- 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:
- 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.
- 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:
- The primary outcome for the exploratory aim is to compare the rate of nicotine metabolism with ST abstinence. Prior research with cigarette smokers shows that the Nicotine Metabolite Ratio (NMR) [i.e., ratio of trans-3'-hydroxycotinine to cotinine) is a predictor of smoking cessation success in particular that "faster metabolizers" treated with NRT or placebo had lower quit rates compared to "slower metabolizers". The exploratory aim will test this association with Smokeless Tobacco users. The number of lozenges used is a data point to help inform this evaluation.
- Conditions
- Smokeless Tobacco Cessation
- Being tested
- Commit® nicotine lozenges (4 mg) & self-help materials, Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials, Phone counseling & self-help materials
- Keywords
- Smokeless Tobacco Use
- Medical subject headings
- Tobacco Use Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Commit® nicotine lozenges (4 mg) & self-help materialsDrug
Also called Active Comparator, Lonzenge + self-help only
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.
Commit® nicotine lozenges (4 mg) & phone counseling & self-help materialsBehavioural
Also called lonzenge + phone + self-help
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.
Phone counseling & self-help materialsBehavioural
Also called phone + self-help only
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.
| Study group | Role | What they receive |
|---|---|---|
| Lozenge Self Help: self help materials & lozenge NRT. | Active comparator | Self-help materials + Commit® nicotine lozenges (4 mg) Receives: Drug: Commit® nicotine lozenges (4 mg) & self-help materials; Behavioral: 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 Receives: Drug: Commit® nicotine lozenges (4 mg) & self-help materials; Behavioral: Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials; Behavioral: Phone counseling & self-help materials |
| Assisted Self-Help: self-help materials & phone counseling without lozenges | Experimental | Self-help materials + Phone counseling Receives: Behavioral: Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials; Behavioral: Phone counseling & self-help materials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Saliva Test for Bio-chemical Verification of Tobacco Abstinence
To verify self-report of prolonged abstinence, saliva will be collected once at 6 months. A salivary cotinine of < 15 ng/mL will be adjudicated as prolonged tobacco abstinence.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2011 (estimated)
- Study startJul 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smokeless Tobacco CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1,067 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Mayo Clinic
- Responsible party
- Sponsor
- Investigators
- Herbert H Severson, PhD, Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01341938
- Sponsor's protocol ID
- R01CA142952
- Other IDs
- R01CA142952-01
- Acronym
- LASH
- Status last verified
- Jul 2021
- First submitted
- 25 Apr 2011
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25977408Severson 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.
PubMed 25168034
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Lozenges and Assisted Self-help for Smokeless Tobacco Cessation
- ClinicalTrials.gov ID
- NCT01341938
- Acronym / sponsor ID
- LASH / R01CA142952
- Conditions
- Smokeless Tobacco Cessation
- Keywords
- Smokeless Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,067 participants (actual)
- Lead sponsor
- Oregon Research InstituteUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Mayo Clinic
- Study start
- Jul 2011 (actual)
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 26 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- The Lozenge Assisted Self-help intervention - lozenge nicotine replacement therapy, phone counseling, and self help materials
- Assisted Self-Help intervention - self-help materials and phone counseling without lozenges
- 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.
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:
- 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.
- 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:
- 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.
- 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:
- The primary outcome for the exploratory aim is to compare the rate of nicotine metabolism with ST abstinence. Prior research with cigarette smokers shows that the Nicotine Metabolite Ratio (NMR) [i.e., ratio of trans-3'-hydroxycotinine to cotinine) is a predictor of smoking cessation success in particular that "faster metabolizers" treated with NRT or placebo had lower quit rates compared to "slower metabolizers". The exploratory aim will test this association with Smokeless Tobacco users. The number of lozenges used is a data point to help inform this evaluation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lozenge Self Help: self help materials & lozenge NRT. | Active comparator | Drug: Commit® nicotine lozenges (4 mg) & self-help materials, Behavioral: Phone counseling & self-help materialsSelf-help materials + Commit® nicotine lozenges (4 mg) |
| Lozenge Assisted Self-help: lozenge NRT, phone counseling, & self help materials | Experimental | Drug: Commit® nicotine lozenges (4 mg) & self-help materials, Behavioral: Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials, Behavioral: Phone counseling & self-help materialsSelf-help materials + Commit® nicotine lozenges (4 mg) + Phone counseling |
| Assisted Self-Help: self-help materials & phone counseling without lozenges | Experimental | Behavioral: Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials, Behavioral: Phone counseling & self-help materialsSelf-help materials + Phone counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commit® nicotine lozenges (4 mg) & self-help materialsAlso: Active Comparator, Lonzenge + self-help onlyParticipants 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. | Drug | Lozenge Assisted Self-help: lozenge NRT, phone counseling, & self help materials, Lozenge Self Help: self help materials & lozenge NRT. |
| Commit® nicotine lozenges (4 mg) & phone counseling & self-help materialsAlso: lonzenge + phone + self-helpThree 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. | Behavioural | Assisted Self-Help: self-help materials & phone counseling without lozenges, Lozenge Assisted Self-help: lozenge NRT, phone counseling, & self help materials |
| Phone counseling & self-help materialsAlso: phone + self-help onlyThree phone counseling sessions to assist in cessation from use of all tobacco + The "Enough Snuff" video and printed guide providing strategies for tobacco cessation. | Behavioural | Assisted Self-Help: self-help materials & phone counseling without lozenges, Lozenge Assisted Self-help: lozenge NRT, phone counseling, & self help materials, Lozenge Self Help: self help materials & lozenge NRT. |
Primary outcome
Prolonged All Tobacco Abstinence
Time frame: 6 months
The primary outcome measure will be self-reported prolonged abstinence from all tobacco use at 3- and 6-month follow-up.
1 secondary outcome
Saliva Test for Bio-chemical Verification of Tobacco Abstinence
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Results publication: PubMed 25977408Ebbert 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.
- Results publication: PubMed 25168034Severson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herbert H Severson, PhD principal investigator
Oregon Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Commit® nicotine lozenges (4 mg) & self-help materials, Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials and Phone counseling & self-help materials in people with Smokeless Tobacco Cessation, run by Oregon Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prolonged All Tobacco Abstinence (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01341938, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.