Tobacco DependenceNCT01928719
Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status
A study testing Reduced Nicotine Content Cigarettes and Same Nicotine Content Cigarettes in people with Tobacco Dependence, run by Milton S. Hershey Medical Center at 2 sites in United States.
Trial summary
The overall goal of this study is to address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in smokers of low socioeconomic status Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Dependence
- What is being tested?
- Reduced Nicotine Content Cigarettes and Same Nicotine Content Cigarettes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Sep 2015to 23 Feb 2018
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65
- Less than 16 years of education
- Able to understand, and sign consent
- Smoke >4 cigarettes/day for at least a year
- No quit attempt in prior 1 month and not planning to quit smoking within next 6 months
- Plan to live in local area for next 8 months
- Able to read and write in English
- Women not pregnant and taking steps to avoid pregnancy
Who cannot join
- College graduate
- Use of psychotropic drugs
- Significant medical condition, or immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data
- Use of any non-cigarette nicotine delivery product in the past week or smoking cessation medicine in prior 3 months
- Currently pregnant or nursing
- Uncontrolled serious psychotic illness or substance abuse
- History of difficulties providing blood samples-fainting, poor veins, anxiety
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Penn State College of Medicine
Hershey, Pennsylvania, 17033
George Washington University School of Public Health
Washington D.C., District of Columbia, 20052
About this study
The overall goal of this study is to address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in smokers of low socioeconomic status
Read the detailed description
To address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in low socioeconomic smokers, we will randomize smokers to either an Reduced Nicotine Content group with a gradual step-wise reduction in nicotine from 11 mg to 0.2 mg per cigarette in five 3-wk stages, or a control group with nicotine content similar to their preferred usual brand of cigarettes.
Overall, we hypothesize that low socioeconomic smokers who switch to progressively lower nicotine cigarettes will initially alter their smoking behavior to compensate for lower nicotine until cigarette nicotine yields become so low that complete compensation becomes too difficult. At that point, smokers will either drop-out or continue to smoke the reduced nicotine content cigarettes but with incomplete compensatory behaviors.
- Conditions
- Tobacco Dependence
- Being tested
- Reduced Nicotine Content Cigarettes, Same Nicotine Content Cigarettes
- Keywords
- Smoking, Nicotine
- Medical subject headings
- Tobacco Use Disorder, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced Nicotine Content CigarettesDrug
Also called Nicotine
Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette
Same Nicotine Content CigarettesDrug
Also called Nicotine
about 11.6 mg nicotine per cigarette
| Study group | Role | What they receive |
|---|---|---|
| Reduced Nicotine Content Cigarettes | Experimental | the experimental group will smoke cigarettes with Gradually Reduced Nicotine Content (RNC) (11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg per cigarette) cigarettes, each smoked for 3 weeks, except for the last period which will last 6 weeks to evaluate a longer-term adherence to the lowest nicotine content cigarette. Receives: Drug: Reduced Nicotine Content Cigarettes |
| Same Nicotine Content Cigarettes | Placebo comparator | The Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette) Receives: Drug: Same Nicotine Content Cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Dropped Out of Study as a Measure of Adherence
Adherence to the regimen was assessed via dropout (due to withdrawal or lost-to-follow up) during the randomized intervention trial phase of the study. Dropout was analyzed as a time-to-event outcome during the 18 weeks after randomization.
Measured: 18 weeks
Secondary outcomes (6)
Predictors of Participant Dropout
Baseline participant characteristics were evaluated for their association with the primary outcome, randomized trial phase dropout. The table below reports the number of participants who dropped out by each characteristic that was found to be univariately associated with the primary outcome.
Measured: 18 weeks
Cigarettes Per Day
Measured by self-reported cigarettes per day at in-person clinic visits using 6-day follow back
Measured: 18 weeks
Nicotine Exposure
Measured by cotinine (ng/ml) measured in plasma
Measured: 18 weeks
Smoke Exposure
Measured in carbon monoxide levels by expired CO
Measured: 18 weeks
Perceived Stress
Perceived Stress is measured via the Perceived Stress Scale Score. The 10-item version was used. Scale range is 0-40. Higher scores indicate more stress.
Measured: 18 weeks
Cortisol
Salivary Cortisol Cortisol is produced by the hypothalamic-pituitary-adrenal axis (HPA) axis in response to stress. Peak cortisol measures during the cortisol awakening response were used.
Measured: 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2013 (estimated)
- Study start9 Sep 2015
- Primary completion5 Jan 2018
- Study completion23 Feb 2018
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 DependenceStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- George Washington University, National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jonathan Foulds, Milton S. Hershey Medical Center
- Investigators
- Joshua Muscat, PhD, Principal investigator, Penn State College of MedicineKimberly Horn, PhD, Study director, George Washington University School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01928719
- Sponsor's protocol ID
- 43804UG-P1
- Other IDs
- P50DA036107-01
- Status last verified
- Apr 2019
- First submitted
- 21 Aug 2013
- Last updated
- 1 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Krebs NM, Allen SI, Veldheer S, Martinez DJ, Horn K, Livelsberger C, Modesto J, Kuprewicz R, Wilhelm A, Hrabovsky S, Kazi A, Fazzi A, Liao J, Zhu J, Wasserman E, Reilly SM, Reinhart L, Trushin N, Moyer RE, Bascom R, Foulds J, Richie JP Jr, Muscat JE. Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial. Trials. 2017 Jul 3;18(1):300. doi: 10.1186/s13063-017-2038-9.
PubMed 28673312
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduced Nicotine Content Cigarettes in Smokers of Lower Socioeconomic Status
- ClinicalTrials.gov ID
- NCT01928719
- Acronym / sponsor ID
- 43804UG-P1
- Conditions
- Tobacco Dependence
- Keywords
- Smoking, Nicotine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- George Washington University, National Institute on Drug Abuse (NIDA)
- Study start
- 9 Sep 2015 (actual)
- Primary completion
- 5 Jan 2018 (actual)
- Study completion
- 23 Feb 2018 (actual)
- First posted
- 27 Aug 2013 (estimated)
- Results
- Posted 12 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall goal of this study is to address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in smokers of low socioeconomic status
Detailed description
To address the question of whether progressively lowering nicotine content in cigarettes can reduce or eliminate nicotine dependence in low socioeconomic smokers, we will randomize smokers to either an Reduced Nicotine Content group with a gradual step-wise reduction in nicotine from 11 mg to 0.2 mg per cigarette in five 3-wk stages, or a control group with nicotine content similar to their preferred usual brand of cigarettes.
Overall, we hypothesize that low socioeconomic smokers who switch to progressively lower nicotine cigarettes will initially alter their smoking behavior to compensate for lower nicotine until cigarette nicotine yields become so low that complete compensation becomes too difficult. At that point, smokers will either drop-out or continue to smoke the reduced nicotine content cigarettes but with incomplete compensatory behaviors.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reduced Nicotine Content Cigarettes | Experimental | Drug: Reduced Nicotine Content Cigarettesthe experimental group will smoke cigarettes with Gradually Reduced Nicotine Content (RNC) (11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg per cigarette) cigarettes, each smoked for 3 weeks, except for the last period which will last 6 weeks to evaluate a longer-term adherence to the lowest nicotine content cigarette. |
| Same Nicotine Content Cigarettes | Placebo comparator | Drug: Same Nicotine Content CigarettesThe Same Nicotine Control Group (SNC) will continue to smoke research cigarettes with a usual nicotine content (about 11.6 mg per cigarette) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-65
- Less than 16 years of education
- Able to understand, and sign consent
- Smoke >4 cigarettes/day for at least a year
- No quit attempt in prior 1 month and not planning to quit smoking within next 6 months
Key exclusion criteria (7 listed)
- College graduate
- Use of psychotropic drugs
- Significant medical condition, or immune system disorders, respiratory diseases, kidney or liver diseases or any other medical disorders that may affect biomarker data
- Use of any non-cigarette nicotine delivery product in the past week or smoking cessation medicine in prior 3 months
- 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 |
|---|---|---|
| Reduced Nicotine Content CigarettesAlso: NicotineCigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette | Drug | Reduced Nicotine Content Cigarettes |
| Same Nicotine Content CigarettesAlso: Nicotineabout 11.6 mg nicotine per cigarette | Drug | Same Nicotine Content Cigarettes |
Primary outcome
Number of Participants Who Dropped Out of Study as a Measure of Adherence
Time frame: 18 weeks
Adherence to the regimen was assessed via dropout (due to withdrawal or lost-to-follow up) during the randomized intervention trial phase of the study. Dropout was analyzed as a time-to-event outcome during the 18 weeks after randomization.
6 secondary outcomes
Predictors of Participant Dropout
Time frame: 18 weeks
Cigarettes Per Day
Time frame: 18 weeks
Nicotine Exposure
Time frame: 18 weeks
Smoke Exposure
Time frame: 18 weeks
Perceived Stress
Time frame: 18 weeks
Cortisol
Time frame: 15 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28673312Krebs NM, Allen SI, Veldheer S, Martinez DJ, Horn K, Livelsberger C, Modesto J, Kuprewicz R, Wilhelm A, Hrabovsky S, Kazi A, Fazzi A, Liao J, Zhu J, Wasserman E, Reilly SM, Reinhart L, Trushin N, Moyer RE, Bascom R, Foulds J, Richie JP Jr, Muscat JE. Reduced nicotine content cigarettes in smokers of low socioeconomic status: study protocol for a randomized control trial. Trials. 2017 Jul 3;18(1):300. doi: 10.1186/s13063-017-2038-9.
- Individual participant dataSharing planned: No
Related trials for Tobacco Dependence
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Recruiting
Young Adult Tobacco/Nicotine and Cannabis Co-use
Tobacco Use Disorder, Nicotine Dependence
Recruiting
Social Media Support Groups for Adolescent Vaping Cessation
Vaping, Vaping Cessation
Recruiting
The INITIATE Study: Initiating Nicotine Dependence Treatment for Smokers Admitted to Emergency Departments
Nicotine Dependence, Cigarettes, Nicotine Withdrawal
Recruiting
Advanced Functional and Structural MRI Techniques for Neuropharmacological Imaging
Drug Abuse, Nicotine Dependence
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.
Joshua Muscat, PhD principal investigator
Penn State College of Medicine
Kimberly Horn, PhD study director
George Washington University School of Public Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced Nicotine Content Cigarettes and Same Nicotine Content Cigarettes in people with Tobacco Dependence, run by Milton S. Hershey Medical Center at 2 sites 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 8 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 1 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 12 Mar 2019). 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 Participants Who Dropped Out of Study as a Measure of Adherence (time frame: 18 weeks). 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 NCT01928719, 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 1 May 2019.