Tobacco Use DisorderNCT01800500
Interest in Smokeless Tobacco Product as a Substitution for Cigarettes in Current Smokers
A study testing smoking cessation intervention, questionnaire administration and quality-of-life assessment in people with Tobacco Use Disorder, run by Roswell Park Cancer Institute at 1 site in United States.
Trial summary
This randomized clinical trial studies interest in smokeless tobacco product as a substitution for cigarettes in current smokers. Use of smokeless tobacco products may help people stop smoking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- smoking cessation intervention, questionnaire administration and quality-of-life assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to May 2015
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must report currently smoke at least 10 cigarettes per day and been smoking for at least 1 year
- Must not be planning to quit smoking in the next 30 days, nor tried to quit in the last 30 days
- Must be able to read and speak English
- Should not concurrently using other tobacco products or nicotine medications
- Willing to try new tobacco products and substitute other brands of cigarettes
- Not current participating in any other ongoing research study
Show all 18Show fewer
- Must be in good general health
- Medically eligible to receive nicotine replacement products (based upon the New York State [NYS] Smokers Quit line eligibility criteria)
- No history of heart attack or stoke in last 2 weeks
- No current use of Zyban, bupropion, Wellbutrin, or Chantix/varenicline, or other smoking cessation medication
- No history of chest pains or angina in past month
- No report of physician diagnosed arrhythmia/irregular heartbeat, fast heartbeat, abnormal heart rate, or use of pacemaker
- No current report of physician diagnosed heart disease/coronary artery disease, high blood pressure (systolic blood pressure [SBP] = 160; diastolic blood pressure [DBP] = 100), stomach ulcer, diabetes, or taking pills for depression or asthma
- No self-reported chronic dental problems that would interfere with using oral products
- No use of an electronic cigarette (e-cigarette) in the past 30 days
- No known sensitivity to glycerol, propylene glycol, or glycerin
- For females, not currently pregnant or breastfeeding; nor planning to become pregnant during the follow-up interval
- Prospective participants must also pass screening tests for substance use, administered at the orientation session, to be entered on study; substance use will be assessed using a Clinical Laboratory Improvement Amendments (CLIA)-waived 7-drug urine screen (detecting presence of tetrahydrocannabinol [THC], opiates, amphetamine, barbiturates, methamphetamine, phencyclidine [PCP], and lysergic acid diethylamide [LSD]); participants must test negative on all 7 to be put on study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Roswell Park Cancer Institute
Buffalo, New York, 14263
About this study
Official title: Exploring Current Smokers' Interest in Using Smokeless Tobacco Products Smokeless Tobacco Substitution for Cigarettes
This randomized clinical trial studies interest in smokeless tobacco product as a substitution for cigarettes in current smokers. Use of smokeless tobacco products may help people stop smoking. Measuring use of other sources of nicotine for cigarettes under a variety of different conditions may help determine whether and how much smokers are willing to use substitutions
Read the detailed description
PRIMARY OBJECTIVES:
- Systematically vary price, availability, product type, and information about products to examine their individual and joint effects on degree of substitution of smokeless products for cigarettes.
II. Examine the impact of smokeless tobacco (ST) substitution on biomarkers of exposure (carbon monoxide [CO], cotinine).
III. Explore relationships between ST substitution and measures of mood and health related quality of life.
OUTLINE: Participants are randomized to 1 of 2 treatment arms.
ARM I: Participants purchase ST products using a fixed rate of product prices once weekly and record their consumption of ST products and cigarettes smoked daily for 3 weeks.
ARM II: Participants purchase ST products using escalating product prices once weekly and record their consumption of ST products and cigarettes smoked daily for 3 weeks.
After completion of study treatment, patients are followed up for 6 months.
- Conditions
- Tobacco Use Disorder
- Being tested
- smoking cessation intervention, questionnaire administration, quality-of-life assessment, laboratory biomarker analysis, ecigarettes
- Medical subject headings
- Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking cessation interventionBehavioural
Purchase ST products using a fixed rate of product prices
smoking cessation interventionBehavioural
Purchase ST products using escalating product prices
questionnaire administrationOther
Ancillary studies
quality-of-life assessmentOther
Also called quality of life assessment
Ancillary studies
laboratory biomarker analysisOther
Correlative studies
ecigarettesOther
Also called ecigarettes, Stonewall, Ariva, Camel Snus, and Marlboro Snus,NRT
Purchase ST products using escalating product prices nicotine replacement therapy
ecigarettesOther
Also called ecigarettes, Stonewall, Ariva, Camel Snus, and Marlboro Snus, NRT
Purchase ST products using a fixed rate of product prices nicotine replacement therapy
| Study group | Role | What they receive |
|---|---|---|
| Arm I (fixed rate ST product prices) | Experimental | Participants purchase ST products using a fixed rate of product prices once weekly and record their consumption of ST products and cigarettes smoked daily for 3 weeks Receives: Behavioral: smoking cessation intervention; Other: questionnaire administration; Other: quality-of-life assessment; Other: laboratory biomarker analysis; Other: ecigarettes |
| Arm II (escalating ST product prices) | Experimental | Participants purchase ST products using escalating product prices once weekly and record their consumption of ST products and cigarettes smoked daily for 3 weeks. Receives: Behavioral: smoking cessation intervention; Other: questionnaire administration; Other: quality-of-life assessment; Other: laboratory biomarker analysis; Other: ecigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of tobacco use accounted for by ST
Tested using hierarchical linear modeling and generalized estimating equations.
Measured: Up to week 5
Proportion of group members that replace at least 50% of baseline cigarette consumption with ST
Assessed using a Fisher's exact test.
Measured: Up to week 5
Change in saliva cotinine
Tested using hierarchical linear modeling and generalized estimating equations.
Measured: Up to week 5
Change in exhaled alveolar CO
Tested using hierarchical linear modeling and generalized estimating equations.
Measured: Up to week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2013 (estimated)
- Study startSep 2011
- Primary completionMay 2015
Why it stopped: Difficulty accruing
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by Roswell Park Cancer InstituteThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Mahoney, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01800500
- Sponsor's protocol ID
- I 165309
- Other IDs
- NCI-2013-00403
- Status last verified
- Sep 2022
- First submitted
- 20 Feb 2013
- Last updated
- 13 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Current Smokers' Interest in Using Smokeless Tobacco Products Smokeless Tobacco Substitution for Cigarettes
- ClinicalTrials.gov ID
- NCT01800500
- Acronym / sponsor ID
- I 165309
- Conditions
- Tobacco Use Disorder
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty accruing
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2015 (actual)
- First posted
- 27 Feb 2013 (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 randomized clinical trial studies interest in smokeless tobacco product as a substitution for cigarettes in current smokers. Use of smokeless tobacco products may help people stop smoking. Measuring use of other sources of nicotine for cigarettes under a variety of different conditions may help determine whether and how much smokers are willing to use substitutions
Detailed description
PRIMARY OBJECTIVES:
- Systematically vary price, availability, product type, and information about products to examine their individual and joint effects on degree of substitution of smokeless products for cigarettes.
II. Examine the impact of smokeless tobacco (ST) substitution on biomarkers of exposure (carbon monoxide [CO], cotinine).
III. Explore relationships between ST substitution and measures of mood and health related quality of life.
OUTLINE: Participants are randomized to 1 of 2 treatment arms.
ARM I: Participants purchase ST products using a fixed rate of product prices once weekly and record their consumption of ST products and cigarettes smoked daily for 3 weeks.
ARM II: Participants purchase ST products using escalating product prices once weekly and record their consumption of ST products and cigarettes smoked daily for 3 weeks.
After completion of study treatment, patients are followed up for 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (fixed rate ST product prices) | Experimental | Behavioral: smoking cessation intervention, Other: questionnaire administration, Other: quality-of-life assessment, Other: laboratory biomarker analysis, Other: ecigarettesParticipants purchase ST products using a fixed rate of product prices once weekly and record their consumption of ST products and cigarettes smoked daily for 3 weeks |
| Arm II (escalating ST product prices) | Experimental | Behavioral: smoking cessation intervention, Other: questionnaire administration, Other: quality-of-life assessment, Other: laboratory biomarker analysis, Other: ecigarettesParticipants purchase ST products using escalating product prices once weekly and record their consumption of ST products and cigarettes smoked daily for 3 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Must report currently smoke at least 10 cigarettes per day and been smoking for at least 1 year
- Must not be planning to quit smoking in the next 30 days, nor tried to quit in the last 30 days
- Must be able to read and speak English
- Should not concurrently using other tobacco products or nicotine medications
- Willing to try new tobacco products and substitute other brands of cigarettes
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| smoking cessation interventionPurchase ST products using a fixed rate of product prices | Behavioural | Arm I (fixed rate ST product prices) |
| smoking cessation interventionPurchase ST products using escalating product prices | Behavioural | Arm II (escalating ST product prices) |
| questionnaire administrationAncillary studies | Other | Arm I (fixed rate ST product prices), Arm II (escalating ST product prices) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Other | Arm I (fixed rate ST product prices), Arm II (escalating ST product prices) |
| laboratory biomarker analysisCorrelative studies | Other | Arm I (fixed rate ST product prices), Arm II (escalating ST product prices) |
| ecigarettesAlso: ecigarettes, Stonewall, Ariva, Camel Snus, and Marlboro Snus,NRTPurchase ST products using escalating product prices nicotine replacement therapy | Other | Arm II (escalating ST product prices) |
| ecigarettesAlso: ecigarettes, Stonewall, Ariva, Camel Snus, and Marlboro Snus, NRTPurchase ST products using a fixed rate of product prices nicotine replacement therapy | Other | Arm I (fixed rate ST product prices) |
Primary outcome
Proportion of tobacco use accounted for by ST
Time frame: Up to week 5
Tested using hierarchical linear modeling and generalized estimating equations.
Proportion of group members that replace at least 50% of baseline cigarette consumption with ST
Time frame: Up to week 5
Assessed using a Fisher's exact test.
Change in saliva cotinine
Time frame: Up to week 5
Tested using hierarchical linear modeling and generalized estimating equations.
Change in exhaled alveolar CO
Time frame: Up to week 5
Tested using hierarchical linear modeling and generalized estimating equations.
Results and safety
The study was stopped early (reason given: Difficulty accruing). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2022.
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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.
Martin Mahoney principal investigator
Roswell Park Cancer 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 smoking cessation intervention, questionnaire administration and quality-of-life assessment in people with Tobacco Use Disorder, run by Roswell Park Cancer 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 18 inclusion and 0 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: stopped early, as of the sponsor's last update on 13 Sep 2022. 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 was stopped early (reason given: Difficulty accruing). Results are not available in the source record.
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?
Proportion of tobacco use accounted for by ST (time frame: Up to week 5). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2022.