SmokingNCT02228824
Very-Low Nicotine Cigarettes and Non-Daily Smokers
A study testing Very low nicotine content cigarettes and Normal nicotine content cigarettes in people with Smoking, run by Saul Shiffman at 1 site in United States.
Trial summary
The purpose of this research study is to investigate the impact of different nicotine levels in cigarettes among non-daily smokers. This research may help inform the Food and Drug Administration (FDA) on how best to regulate tobacco products in the future, with the goal of improving public health. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking
- What is being tested?
- Very low nicotine content cigarettes and Normal nicotine content cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 312 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 31 Jul 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or older, and smoking cigarettes for at least 3 years
- smoking, on average, 4-27 days per month
- smoking at current rate for at least the previous 3 months
- willingness to try novel cigarettes
Who cannot join
- active plans to quit or actively seeking smoking cessation treatment in the next 3 months
- severe psychiatric disorders that may interfere with study procedures
- current, regular (i.e., monthly or more) use of nicotine replacement or other tobacco products, by self-report
- exclusive use of roll-your-own cigarettes (since the study uses manufactured cigarettes)
- [for female participants] being pregnant or breastfeeding, or planning to become pregnant, by self-report
- current use of medications such as Chantix (varenicline), Zyban, Wellbutrin, or bupropion for any purpose, including stopping smoking
- occurrence of heart attack, stroke, or angina in the past 3 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Smoking Research Group, University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: The Effect of Very-Low Nicotine Cigarettes on Smoking in Non-Daily Smokers
The purpose of this research study is to investigate the impact of different nicotine levels in cigarettes among non-daily smokers. This research may help inform the Food and Drug Administration (FDA) on how best to regulate tobacco products in the future, with the goal of improving public health.
Read the detailed description
The overall goal of the study is to assess the effects of switching to Very-Low-Nicotine-Content cigarettes (VLNCCs) among non-daily, or intermittent smokers (ITS). This is a two-arm randomized study with an own-cigarette baseline control. After a 2-week baseline period smoking their own cigarettes, 455 ITS will be randomized (double-blind) for 10 weeks to smoke experimental cigarettes, either: (a) normal nicotine content cigarettes (NNCCs; 0.8 mg) or (b) VLNCCs (0.07 mg), each matched to menthol status of subjects' preferred brand. ITS are more likely to be African-American (AA) smokers; thus AA smokers will be oversampled (to one third of the total sample). Change in cigarette consumption is the primary end-point, and biomarkers of smoke exposure and measures of smoking intensity are also assessed.
- Conditions
- Smoking
- Being tested
- Very low nicotine content cigarettes, Normal nicotine content cigarettes
- Keywords
- Smoking, Non-daily smokers, Ecological Momentary Assessment, Biomarkers
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Very low nicotine content cigarettesDrug
0.07 mg nicotine delivery
Normal nicotine content cigarettesDrug
0.8 mg nicotine delivery
| Study group | Role | What they receive |
|---|---|---|
| Very low nicotine content cigarettes | Experimental | Not described Receives: Drug: Very low nicotine content cigarettes |
| Normal nicotine content cigarettes | Active comparator | Not described Receives: Drug: Normal nicotine content cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cigarette Consumption
Difference in mean daily cigarette consumption between initial two-week baseline period and final two weeks of experimental period, using imputed data
Measured: Two-week pre-intervention baseline period compared to final two weeks of 10-week intervention period
Secondary outcomes (4)
Exposure Measure - Solanesol
The concentration of solanesol, a stable marker indicator of how much smoke has passed through the filter of a smoked cigarette to the smoker, will be assayed as a measure of smoking intensity. The filter of a cigarette butts smoked during the baseline period will be compared to those smoked during the experimental period.
Measured: Post-randomization time points at study weeks 4, 8, 12
Exposure Measure - Smoking Topography
Difference between average puff volume per cigarette at laboratory smoking topography sessions at study weeks 4, 8, and 12 across all participants, comparing those assigned to the very-low-nicotine-content cigarette condition to those assigned to the normal-nicotine-content cigarette condition. Topography measures were averaged across all time points for each treatment group.
Measured: Post-randomization study visits at study weeks 4, 8, 12
Exposure Measure - Cotinine (Logged)
Cotinine nicotine exposure measure, analyzed from urine samples taken at study office visits
The natural logarithm (ln) of the cotinine measures was used for analysis.
Difference in ln(cotinine) between baseline and end of study, from imputed data
Measured: Post-randomization office visits weeks 2 (end of baseline period) and 12 (end of study)
Exposure Measure - Cigarette Butt Weight
Mean mass smoked per cigarette (calculated as the starting cigarette weight minus returned butt weight) aggregated for all cigarettes smoked among participants assigned to the very-low-nicotine-content cigarette, compared to those assigned to the normal-nicotine-content cigarette condition.
Measured: Entire length of study, through completion, up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2014 (estimated)
- Study startJun 2015
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
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 SmokingStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 312 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saul Shiffman
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor-investigator, Saul Shiffman, University of Pittsburgh
- Investigators
- Saul Shiffman, PhD, Principal investigator, University of Pittsburgh, Department of Psychology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02228824
- Sponsor's protocol ID
- 3P30CA047904-25S4
- Status last verified
- Oct 2018
- First submitted
- 27 Aug 2014
- Last updated
- 31 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Shiffman S, Kurland BF, Scholl SM, Mao JM. Nondaily Smokers' Changes in Cigarette Consumption With Very Low-Nicotine-Content Cigarettes: A Randomized Double-blind Clinical Trial. JAMA Psychiatry. 2018 Oct 1;75(10):995-1002. doi: 10.1001/jamapsychiatry.2018.1831.
PubMed 29902305
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Very-Low Nicotine Cigarettes on Smoking in Non-Daily Smokers
- ClinicalTrials.gov ID
- NCT02228824
- Acronym / sponsor ID
- 3P30CA047904-25S4
- Conditions
- Smoking
- Keywords
- Smoking, Non-daily smokers, Ecological Momentary Assessment, Biomarkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 312 participants (actual)
- Lead sponsor
- Saul ShiffmanUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2015 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 29 Aug 2014 (estimated)
- Results
- Posted 31 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to investigate the impact of different nicotine levels in cigarettes among non-daily smokers. This research may help inform the Food and Drug Administration (FDA) on how best to regulate tobacco products in the future, with the goal of improving public health.
Detailed description
The overall goal of the study is to assess the effects of switching to Very-Low-Nicotine-Content cigarettes (VLNCCs) among non-daily, or intermittent smokers (ITS). This is a two-arm randomized study with an own-cigarette baseline control. After a 2-week baseline period smoking their own cigarettes, 455 ITS will be randomized (double-blind) for 10 weeks to smoke experimental cigarettes, either: (a) normal nicotine content cigarettes (NNCCs; 0.8 mg) or (b) VLNCCs (0.07 mg), each matched to menthol status of subjects' preferred brand. ITS are more likely to be African-American (AA) smokers; thus AA smokers will be oversampled (to one third of the total sample). Change in cigarette consumption is the primary end-point, and biomarkers of smoke exposure and measures of smoking intensity are also assessed.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Very low nicotine content cigarettes | Experimental | Drug: Very low nicotine content cigarettes |
| Normal nicotine content cigarettes | Active comparator | Drug: Normal nicotine content cigarettes |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18 years or older, and smoking cigarettes for at least 3 years
- smoking, on average, 4-27 days per month
- smoking at current rate for at least the previous 3 months
- willingness to try novel cigarettes
Key exclusion criteria (7 listed)
- active plans to quit or actively seeking smoking cessation treatment in the next 3 months
- severe psychiatric disorders that may interfere with study procedures
- current, regular (i.e., monthly or more) use of nicotine replacement or other tobacco products, by self-report
- exclusive use of roll-your-own cigarettes (since the study uses manufactured cigarettes)
- [for female participants] being pregnant or breastfeeding, or planning to become pregnant, by self-report
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 |
|---|---|---|
| Very low nicotine content cigarettes0.07 mg nicotine delivery | Drug | Very low nicotine content cigarettes |
| Normal nicotine content cigarettes0.8 mg nicotine delivery | Drug | Normal nicotine content cigarettes |
Primary outcome
Change in Cigarette Consumption
Time frame: Two-week pre-intervention baseline period compared to final two weeks of 10-week intervention period
Difference in mean daily cigarette consumption between initial two-week baseline period and final two weeks of experimental period, using imputed data
4 secondary outcomes
Exposure Measure - Solanesol
Time frame: Post-randomization time points at study weeks 4, 8, 12
Exposure Measure - Smoking Topography
Time frame: Post-randomization study visits at study weeks 4, 8, 12
Exposure Measure - Cotinine (Logged)
Time frame: Post-randomization office visits weeks 2 (end of baseline period) and 12 (end of study)
Exposure Measure - Cigarette Butt Weight
Time frame: Entire length of study, through completion, up to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29902305Shiffman S, Kurland BF, Scholl SM, Mao JM. Nondaily Smokers' Changes in Cigarette Consumption With Very Low-Nicotine-Content Cigarettes: A Randomized Double-blind Clinical Trial. JAMA Psychiatry. 2018 Oct 1;75(10):995-1002. doi: 10.1001/jamapsychiatry.2018.1831.
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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.
Saul Shiffman, PhD principal investigator
University of Pittsburgh, Department of Psychology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Very low nicotine content cigarettes and Normal nicotine content cigarettes in people with Smoking, run by Saul Shiffman 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 4 inclusion and 7 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 Oct 2018. 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 Oct 2018). 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?
Change in Cigarette Consumption (time frame: Two-week pre-intervention baseline period compared to final two weeks of 10-week intervention period). 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 NCT02228824, 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 Oct 2018.