SmokingPhase 1/2NCT00932295
Evaluating the Acute Effects of Electronic Nicotine Delivery Devices Marketed to Smokers.
A Phase 1/2 study testing OB, CROWN SEVEN and NJOY in people with Smoking, run by Virginia Commonwealth University at 1 site in United States.
Trial summary
The study's aim is to develop a clinical model that can be used to measure the nicotine delivery and tobacco/nicotine abstinence-suppressing capability of electronic devices that are marketed as a means to deliver nicotine to cigarette smokers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- OB, CROWN SEVEN and NJOY
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Oct 2009
- Phase
- Phase 1/2
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Participants must be healthy, between 18 and 55 years of age, and report a cigarette intake of > 15 cig/day for at least 1 year. They must provide an afternoon screening CO level of > 15 ppm at intake. They must also provide a urine sample for cotinine analysis, and receive a result of at least 4 on the urine immunoassay test strip scale (possible range = 0-6) at intake.
Who cannot join
- Exclusion criteria include: history of chronic health problems or psychiatric conditions, breastfeeding, or pregnancy (assessed by urinalysis). Individuals who report current attempts to quit smoking, previous experience with Crown Seven or NJOY. Individuals who report alcohol or marijuana use greater than 20 days within the last 30 days, or recent illicit drug use such as cocaine or heroin. Women reporting active menopause will be excluded (menopause may cause tobacco/nicotine withdrawal-like symptoms, such as depression, Parry et al., 2001).
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical Behavioral Pharmacology Laboratory
Richmond, Virginia, 23298
About this study
The study's aim is to develop a clinical model that can be used to measure the nicotine delivery and tobacco/nicotine abstinence-suppressing capability of electronic devices that are marketed as a means to deliver nicotine to cigarette smokers. The study will compare the nicotine delivery, cardiovascular effects, and tobacco withdrawal suppressing effects of two devices currently marketed in the U.S.: Crown Seven and NJOY. Specifically, the effects of these devices will be compared with the effects of own brand cigarettes (positive control), and an abstinence condition (sham smoking; puffing from an unlit cigarette). The primary hypothesis is that the nicotine delivery, withdrawal suppression, and other effects of electronic devices marketed as a means to deliver nicotine to smokers can be measured during a period of acute exposure.
Read the detailed description
Potential reduced exposure products (PREPs) are being developed and marketed by the tobacco industry in an attempt to reduce some of the risks involved in tobacco use (see Breland et al., 2002b). Evaluating the effects of these products is crucial to public health, as past industry-sponsored efforts at harm reduction (e.g., so-called "light" and "ultra-light" cigarettes) were not evaluated and failed to reduce carbon monoxide (CO), nicotine, and carcinogen exposure in smokers; these efforts thus failed to reduce the harms of smoking (Stratton et al., 2001). This study is part of an on-going, NIH-funded program of research to develop a science-based model that uses outcome measures relevant to evaluating current tobacco industry-sponsored smoking harm reduction efforts systematically and efficiently.
- Conditions
- Smoking
- Being tested
- OB, Sham smoking, CROWN SEVEN, NJOY
- Keywords
- tobacco, cigarette, nicotine
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OBOther
10 puffs from the participants own brand brand of cigarette (lit; 30 second inter puff interval)
Sham smokingOther
10 puffs from the participants own brand brand of cigarette (NOT lit; 30 second inter puff interval)
CROWN SEVENOther
10 puffs from a so-called "electronic cigarette" named CROWN SEVEN (16 mg cartridge; 30 second inter puff interval)
NJOYOther
10 puffs from a so-called "electronic cigarette" named NJOY(16 mg cartridge; 30 second inter puff interval)
| Study group | Role | What they receive |
|---|---|---|
| Own brand cigarette | Active comparator | 10 puffs from the participants own brand brand of cigarette (lit; 30 second inter puff interval) Receives: Other: OB |
| Sham smoking | Sham comparator | 10 puffs from the participants own brand brand of cigarette (NOT lit; 30 second inter puff interval) Receives: Other: Sham smoking |
| Electronic cigarette Version One C7 | Experimental | 10 puffs from a so-called "electronic cigarette" named CROWN SEVEN (16 mg cartridge; 30 second inter puff interval) Receives: Other: CROWN SEVEN |
| Electronic cigarette version 2: NJ | Experimental | 10 puffs from a so-called "electronic cigarette" named NJOY (16 mg cartridge; 30 second inter puff interval) Receives: Other: NJOY |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma nicotine concentration (ng/ml)
Measured: baseline, 5, 15, 30, and 45 minutes post-use
Secondary outcomes (2)
Heart rate
Measured: continuous
Withdrawal suppression (subjective measure)
Measured: baseline and 5, 15, 30, and 45 minutes post-use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2009 (estimated)
- Study startFeb 2009
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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 1/2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Thomas Eissenberg, Ph.D., Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00932295
- Sponsor's protocol ID
- HM11820
- Other IDs
- R01CA103827, R01CA120142
- Status last verified
- Dec 2016
- First submitted
- 2 Jul 2009
- Last updated
- 13 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Cobb CO, Weaver MF, Eissenberg T. Evaluating the acute effects of oral, non-combustible potential reduced exposure products marketed to smokers. Tob Control. 2010 Oct;19(5):367-73. doi: 10.1136/tc.2008.028993. Epub 2009 Apr 2.
PubMed 19346218Gray JN, Breland AB, Weaver M, Eissenberg T. Potential reduced exposure products (PREPs) for smokeless tobacco users: clinical evaluation methodology. Nicotine Tob Res. 2008 Sep;10(9):1441-8. doi: 10.1080/14622200802323258.
PubMed 19023835Blank MD, Sams C, Weaver MF, Eissenberg T. Nicotine delivery, cardiovascular profile, and subjective effects of an oral tobacco product for smokers. Nicotine Tob Res. 2008 Mar;10(3):417-21. doi: 10.1080/14622200801901880.
PubMed 18324559Breland AB, Kleykamp BA, Eissenberg T. Clinical laboratory evaluation of potential reduced exposure products for smokers. Nicotine Tob Res. 2006 Dec;8(6):727-38. doi: 10.1080/14622200600789585.
PubMed 17132520Breland AB, Evans SE, Buchhalter AR, Eissenberg T. Acute effects of Advance: a potential reduced exposure product for smokers. Tob Control. 2002 Dec;11(4):376-8. doi: 10.1136/tc.11.4.376.
PubMed 12432165
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Acute Effects of Electronic Nicotine Delivery Devices Marketed to Smokers.
- ClinicalTrials.gov ID
- NCT00932295
- Acronym / sponsor ID
- HM11820
- Conditions
- Smoking
- Keywords
- tobacco, cigarette, nicotine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Feb 2009
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 3 Jul 2009 (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.
The study's aim is to develop a clinical model that can be used to measure the nicotine delivery and tobacco/nicotine abstinence-suppressing capability of electronic devices that are marketed as a means to deliver nicotine to cigarette smokers. The study will compare the nicotine delivery, cardiovascular effects, and tobacco withdrawal suppressing effects of two devices currently marketed in the U.S.: Crown Seven and NJOY. Specifically, the effects of these devices will be compared with the effects of own brand cigarettes (positive control), and an abstinence condition (sham smoking; puffing from an unlit cigarette). The primary hypothesis is that the nicotine delivery, withdrawal suppression, and other effects of electronic devices marketed as a means to deliver nicotine to smokers can be measured during a period of acute exposure.
Detailed description
Potential reduced exposure products (PREPs) are being developed and marketed by the tobacco industry in an attempt to reduce some of the risks involved in tobacco use (see Breland et al., 2002b). Evaluating the effects of these products is crucial to public health, as past industry-sponsored efforts at harm reduction (e.g., so-called "light" and "ultra-light" cigarettes) were not evaluated and failed to reduce carbon monoxide (CO), nicotine, and carcinogen exposure in smokers; these efforts thus failed to reduce the harms of smoking (Stratton et al., 2001). This study is part of an on-going, NIH-funded program of research to develop a science-based model that uses outcome measures relevant to evaluating current tobacco industry-sponsored smoking harm reduction efforts systematically and efficiently.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Own brand cigarette | Active comparator | Other: OB10 puffs from the participants own brand brand of cigarette (lit; 30 second inter puff interval) |
| Sham smoking | Sham comparator | Other: Sham smoking10 puffs from the participants own brand brand of cigarette (NOT lit; 30 second inter puff interval) |
| Electronic cigarette Version One C7 | Experimental | Other: CROWN SEVEN10 puffs from a so-called "electronic cigarette" named CROWN SEVEN (16 mg cartridge; 30 second inter puff interval) |
| Electronic cigarette version 2: NJ | Experimental | Other: NJOY10 puffs from a so-called "electronic cigarette" named NJOY (16 mg cartridge; 30 second inter puff interval) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Participants must be healthy, between 18 and 55 years of age, and report a cigarette intake of > 15 cig/day for at least 1 year. They must provide an afternoon screening CO level of > 15 ppm at intake. They must also provide a urine sample for cotinine analysis, and receive a result of at least 4 on the urine immunoassay test strip scale (possible range = 0-6) at intake.
Key exclusion criteria (1 listed)
- Exclusion criteria include: history of chronic health problems or psychiatric conditions, breastfeeding, or pregnancy (assessed by urinalysis). Individuals who report current attempts to quit smoking, previous experience with Crown Seven or NJOY. Individuals who report alcohol or marijuana use greater than 20 days within the last 30 days, or recent illicit drug use such as cocaine or heroin. Women reporting active menopause will be excluded (menopause may cause tobacco/nicotine withdrawal-like symptoms, such as depression, Parry et al., 2001).
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 |
|---|---|---|
| OB10 puffs from the participants own brand brand of cigarette (lit; 30 second inter puff interval) | Other | Own brand cigarette |
| Sham smoking10 puffs from the participants own brand brand of cigarette (NOT lit; 30 second inter puff interval) | Other | Sham smoking |
| CROWN SEVEN10 puffs from a so-called "electronic cigarette" named CROWN SEVEN (16 mg cartridge; 30 second inter puff interval) | Other | Electronic cigarette Version One C7 |
| NJOY10 puffs from a so-called "electronic cigarette" named NJOY(16 mg cartridge; 30 second inter puff interval) | Other | Electronic cigarette version 2: NJ |
Primary outcome
Plasma nicotine concentration (ng/ml)
Time frame: baseline, 5, 15, 30, and 45 minutes post-use
2 secondary outcomes
Heart rate
Time frame: continuous
Withdrawal suppression (subjective measure)
Time frame: baseline and 5, 15, 30, and 45 minutes post-use
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 13 Dec 2016.
- Background: PubMed 19346218Cobb CO, Weaver MF, Eissenberg T. Evaluating the acute effects of oral, non-combustible potential reduced exposure products marketed to smokers. Tob Control. 2010 Oct;19(5):367-73. doi: 10.1136/tc.2008.028993. Epub 2009 Apr 2.
- Background: PubMed 19023835Gray JN, Breland AB, Weaver M, Eissenberg T. Potential reduced exposure products (PREPs) for smokeless tobacco users: clinical evaluation methodology. Nicotine Tob Res. 2008 Sep;10(9):1441-8. doi: 10.1080/14622200802323258.
- Background: PubMed 18324559Blank MD, Sams C, Weaver MF, Eissenberg T. Nicotine delivery, cardiovascular profile, and subjective effects of an oral tobacco product for smokers. Nicotine Tob Res. 2008 Mar;10(3):417-21. doi: 10.1080/14622200801901880.
- Background: PubMed 17132520Breland AB, Kleykamp BA, Eissenberg T. Clinical laboratory evaluation of potential reduced exposure products for smokers. Nicotine Tob Res. 2006 Dec;8(6):727-38. doi: 10.1080/14622200600789585.
- Background: PubMed 12432165Breland AB, Evans SE, Buchhalter AR, Eissenberg T. Acute effects of Advance: a potential reduced exposure product for smokers. Tob Control. 2002 Dec;11(4):376-8. doi: 10.1136/tc.11.4.376.
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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.
Thomas Eissenberg, Ph.D. principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing OB, CROWN SEVEN and NJOY in people with Smoking, run by Virginia Commonwealth University 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 1 inclusion and 1 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 13 Dec 2016. 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. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Plasma nicotine concentration (ng/ml) (time frame: baseline, 5, 15, 30, and 45 minutes post-use). 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 NCT00932295, which also lists 5 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 13 Dec 2016.