Tobacco AddictionNCT02000921
Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors
A study testing VLNC cigarettes, Combusted Products and Non-combusted products in people with Tobacco Addiction and Dual Tobacco Use, run by University of Minnesota at 1 site in United States.
Trial summary
The main focus of this study is to determine the use of nicotine-containing products across the three experimental conditions. Subjects will be monitored to determine their continued use of assigned cigarettes, switching to other combusted and/or non-combusted tobacco, or cessation of all tobacco containing products. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Addiction, Dual Tobacco Use
- What is being tested?
- VLNC cigarettes, Combusted Products and Non-combusted products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Male or female subjects who are at least 18 years of age with a history of regular smoking for at least 1 year and no serious quit attempts in the last 3 months
- No unstable and significant medical or psychiatric conditions, including lack of stabilization of medications.
- Subject has provided written informed consent to participate in the study
Who cannot join
- Regular use of tobacco products (including e-cigarettes) other than cigarettes
- Regular use of nicotine replacement or other tobacco cessation products for purpose of quitting.
- Pregnant or breastfeeding (due to toxic effects from tobacco products).
- Planned quit date within the next two months.
- Does not have a way that the research team can communicate with them by phone or e-mail.
- Not able to read and write English well enough to complete study activities without translation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Tobacco Research Program
Minneapolis, Minnesota, 55414
About this study
Official title: Models for Tobacco Productive Evaluation: Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors
The main focus of this study is to determine the use of nicotine-containing products across the three experimental conditions. Subjects will be monitored to determine their continued use of assigned cigarettes, switching to other combusted and/or non-combusted tobacco, or cessation of all tobacco containing products.
Read the detailed description
This is a single site, single-blind, randomized trial with three experimental conditions tested for a period of 8 weeks: 1) Very low nicotine content (VLNC) cigarettes (0.07 nicotine yield) with access to combusted (except cigarettes) and non-combusted tobacco and medicinal nicotine products; 2) VLNC cigarettes with access to only non-combusted tobacco and medicinal nicotine products; and 3) conventional nicotine (CN) content experimental cigarettes (0.8 mg nicotine) with access to combusted and non-combusted products. This study will examine the use of nicotine-containing products across the three experimental conditions. Subjects will be monitored to determine their continued use of assigned cigarettes, switching to other combusted (e.g., little cigars, large cigars, pipes) and/or non-combusted tobacco products (e.g., conventional smokeless tobacco, snus for smokers, dissolvables, e-cigarettes, medicinal nicotine), or cessation of all tobacco containing products. Toxicant exposure across the three conditions will also be examined.
Eligible subjects will be provided very low nicotine content cigarettes and are told to use the product ad lib for 8 weeks. Subjects will complete questionnaires on demographics, smoking and health history, drug and alcohol use history, mood and perceptions of the study tobacco product. Biomarker samples will be analyzed for exposure levels of nicotine and tobacco-related toxicants.
- Conditions
- Tobacco Addiction, Dual Tobacco Use
- Being tested
- VLNC cigarettes, Combusted Products, Non-combusted products, CN cigarettes
- Keywords
- Cigarette Smoking, Very Low Nicotine Content cigarettes (VLNC), Dual Tobacco Use
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VLNC cigarettesOther
Also called Very Low Nicotine Content Cigarettes
Modified risk tobacco product
Combusted ProductsOther
Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
Non-combusted productsOther
Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
CN cigarettesOther
Experimental cigarettes with conventional nicotine content.
| Study group | Role | What they receive |
|---|---|---|
| CN + combusted & non-combusted products | Experimental | Subjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time. Receives: Other: Combusted Products; Other: Non-combusted products; Other: CN cigarettes |
| VLNC + combusted & non-combusted products | Experimental | Subjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time. Receives: Other: VLNC cigarettes; Other: Combusted Products; Other: Non-combusted products |
| VLNC with non-combusted products | Experimental | Subjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products. Receives: Other: VLNC cigarettes; Other: Non-combusted products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Days Using Alternative Products
The primary aim of the study is to determine the rate of use of alternative nicotine-containing products across the three experimental conditions.
Measured: 8 week intervetnion period
Number of Combusted Products Smoked
Number of combusted products smoked per day during the last two weeks of the intervention period.
Measured: At weeks 6-8 (last two weeks of intervention period)
Secondary outcomes (2)
Rate of 24 Hour Quit Attempts
Rate of 24 hour quit attempts during the intervention period
Measured: 8 week intervention period
Carcinogen Exposure Biomarker: Total NNAL
Total NNAL (pmol/mg creatinine) is a measure of carcinogen exposure assessed at the end of intervention.
Measured: Week 8 (end of intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionSep 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco AddictionStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Dorothy K Hatsukami, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02000921
- Sponsor's protocol ID
- 2013NTLS012
- Other IDs
- U19CA157345
- Status last verified
- Feb 2017
- First submitted
- 27 Nov 2013
- Last updated
- 31 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Hatsukami DK, Luo X, Dick L, Kangkum M, Allen SS, Murphy SE, Hecht SS, Shields PG, al'Absi M. Reduced nicotine content cigarettes and use of alternative nicotine products: exploratory trial. Addiction. 2017 Jan;112(1):156-167. doi: 10.1111/add.13603. Epub 2016 Nov 2.
PubMed 27614097
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Models for Tobacco Productive Evaluation: Reduced Nicotine Content Cigarettes and Tobacco Switching Behaviors
- ClinicalTrials.gov ID
- NCT02000921
- Acronym / sponsor ID
- 2013NTLS012
- Conditions
- Tobacco Addiction, Dual Tobacco Use
- Keywords
- Cigarette Smoking, Very Low Nicotine Content cigarettes (VLNC), Dual Tobacco Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2013
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 4 Dec 2013 (estimated)
- Results
- Posted 31 Mar 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main focus of this study is to determine the use of nicotine-containing products across the three experimental conditions. Subjects will be monitored to determine their continued use of assigned cigarettes, switching to other combusted and/or non-combusted tobacco, or cessation of all tobacco containing products.
Detailed description
This is a single site, single-blind, randomized trial with three experimental conditions tested for a period of 8 weeks: 1) Very low nicotine content (VLNC) cigarettes (0.07 nicotine yield) with access to combusted (except cigarettes) and non-combusted tobacco and medicinal nicotine products; 2) VLNC cigarettes with access to only non-combusted tobacco and medicinal nicotine products; and 3) conventional nicotine (CN) content experimental cigarettes (0.8 mg nicotine) with access to combusted and non-combusted products. This study will examine the use of nicotine-containing products across the three experimental conditions. Subjects will be monitored to determine their continued use of assigned cigarettes, switching to other combusted (e.g., little cigars, large cigars, pipes) and/or non-combusted tobacco products (e.g., conventional smokeless tobacco, snus for smokers, dissolvables, e-cigarettes, medicinal nicotine), or cessation of all tobacco containing products. Toxicant exposure across the three conditions will also be examined.
Eligible subjects will be provided very low nicotine content cigarettes and are told to use the product ad lib for 8 weeks. Subjects will complete questionnaires on demographics, smoking and health history, drug and alcohol use history, mood and perceptions of the study tobacco product. Biomarker samples will be analyzed for exposure levels of nicotine and tobacco-related toxicants.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CN + combusted & non-combusted products | Experimental | Other: Combusted Products, Other: Non-combusted products, Other: CN cigarettesSubjects will be asked to smoke the assigned conventional nicotine content (CN) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time. |
| VLNC + combusted & non-combusted products | Experimental | Other: VLNC cigarettes, Other: Combusted Products, Other: Non-combusted productsSubjects will be asked to smoke the assigned very low nicotine content (VLNC) cigarettes, instead of their normal brand, for 8 weeks and will also be given access to use other combusted and non-combusted tobacco and medicinal nicotine products during that time. |
| VLNC with non-combusted products | Experimental | Other: VLNC cigarettes, Other: Non-combusted productsSubjects will be asked to smoke very low nicotine content (VLNC) cigarettes instead of their usual cigarettes for an 8 week period and will be given the opportunity to use non-combusted types of tobacco and medicinal tobacco products. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female subjects who are at least 18 years of age with a history of regular smoking for at least 1 year and no serious quit attempts in the last 3 months
- No unstable and significant medical or psychiatric conditions, including lack of stabilization of medications.
- Subject has provided written informed consent to participate in the study
Key exclusion criteria (6 listed)
- Regular use of tobacco products (including e-cigarettes) other than cigarettes
- Regular use of nicotine replacement or other tobacco cessation products for purpose of quitting.
- Pregnant or breastfeeding (due to toxic effects from tobacco products).
- Planned quit date within the next two months.
- Does not have a way that the research team can communicate with them by phone or e-mail.
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 |
|---|---|---|
| VLNC cigarettesAlso: Very Low Nicotine Content CigarettesModified risk tobacco product | Other | VLNC + combusted & non-combusted products, VLNC with non-combusted products |
| Combusted ProductsOptions for combusted tobacco products include cigars, cigarillos, and little cigars, . | Other | CN + combusted & non-combusted products, VLNC + combusted & non-combusted products |
| Non-combusted productsOptions for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine. | Other | CN + combusted & non-combusted products, VLNC + combusted & non-combusted products, VLNC with non-combusted products |
| CN cigarettesExperimental cigarettes with conventional nicotine content. | Other | CN + combusted & non-combusted products |
Primary outcome
Number of Days Using Alternative Products
Time frame: 8 week intervetnion period
The primary aim of the study is to determine the rate of use of alternative nicotine-containing products across the three experimental conditions.
Number of Combusted Products Smoked
Time frame: At weeks 6-8 (last two weeks of intervention period)
Number of combusted products smoked per day during the last two weeks of the intervention period.
2 secondary outcomes
Rate of 24 Hour Quit Attempts
Time frame: 8 week intervention period
Carcinogen Exposure Biomarker: Total NNAL
Time frame: Week 8 (end of intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27614097Hatsukami DK, Luo X, Dick L, Kangkum M, Allen SS, Murphy SE, Hecht SS, Shields PG, al'Absi M. Reduced nicotine content cigarettes and use of alternative nicotine products: exploratory trial. Addiction. 2017 Jan;112(1):156-167. doi: 10.1111/add.13603. Epub 2016 Nov 2.
- Individual participant dataSharing planned: No
Related trials for Tobacco Addiction
RecruitingPhase 4
Addiction Potential of Very Low Nicotine Filtered Little Cigars
Smoking (Tobacco) Addiction
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
Active, not recruiting
THE EFFECT OF A TRANSTHEORETICAL MODEL-BASED CHATBOT SUPPORT INTERVENTION ON SMOKING BEHAVIOR IN UNIVERSITY STUDENTS
Smoking ( Cigarette), Smoking (Tobacco) Addiction
Recruiting
Impact of Novel vs. Usual Brand Menthol Cigarettes on Abuse Liability
Cigarette Addiction, Tobacco Use Disorder
Recruiting
Interventional Study on Smoking Reduction in Psychiatry
Tobacco Addiction
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.
Dorothy K Hatsukami, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VLNC cigarettes, Combusted Products and Non-combusted products in people with Tobacco Addiction and Dual Tobacco Use, run by University of Minnesota 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 3 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 31 Mar 2017. 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?
Yes. Results are posted in the registry (first posted 31 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Days Using Alternative Products (time frame: 8 week intervetnion period). The study lists 2 primary outcomes in all. 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 NCT02000921, which also lists 1 linked publication.
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 31 Mar 2017.