Nicotine DependencePhase 1/2Ecig1NCT02590393
The Role of Nicotine and Non-Nicotine Alkaloids in E-Cigarette Use and Dependence
A Phase 1/2 study testing E-cigarettes in people with Nicotine Dependence, run by Duke University at 1 site in United States.
Trial summary
The advent of electronic cigarette (e-cigarette) technologies represents one of the most significant developments in the last several decades, and provides a novel and promising strategy for substantially reducing the morbidity and mortality associated with smoking. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Nicotine Dependence
- What is being tested?
- E-cigarettes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2021to 13 Jan 2022
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have no known serious medical conditions;
- Are 21-65 years old;
- Smoke an average of at least 10 cigarettes per day;
- Have smoked at least one cumulative year;
- Have an expired air CO reading of at least 10ppm;
- Are able to read and understand English.
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- Potential subjects must agree to use acceptable contraception during their participation in this study. Potential subjects must agree to avoid the following during their participation in this study:
- Participation in any other nicotine-related modification strategy outside of this protocol;
- Use of tobacco products other than cigarettes, including pipe tobacco, cigars, snuff, and chewing tobacco;
- Use of e-cigarettes other than the ones provided during the study;
- Use of experimental (investigational) drugs or devices;
- Use of illegal drugs.
Who cannot join
- Actively seeking treatment for nicotine dependence;
- Uncontrolled high blood pressure (self-report);
- Coronary heart disease with symptoms (e.g., chest pain);
- Heart attack in the past year;
- Cardiac rhythm disorder (irregular heart rhythm with symptoms);
- Chest pain in the last month (unless history indicates a non-cardiac source);
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- Symptomatic heart disorder such as heart failure;
- Advanced liver or kidney disease that requires medication or dialysis, paracentesis;
- Bleeding stomach ulcers in the past 30 days;
- Lung disease that requires oxygen;
- Major brain disorder (including stroke with residual deficit, brain tumor, and seizure disorder);
- Migraine headaches that occur more frequently than once per week;
- Recent, unexplained fainting spells;
- Diabetes with insulin use;
- Current cancer or treatment for cancer in the past six months (except basal or squamous cell skin cancer);
- Other major medical condition (as determined by study medical provider);
- Diagnosis of thought disorder; such as bipolar disorder or schizophrenia;
- Psychiatric hospitalization within the past 12 months;
- Pregnant or nursing mothers;
- Use (within the past 7 days) of illegal drugs (or if the urine drug screen is positive for THC, Cocaine, Amphetamine, Opiates, Methamphetamines, PCP, Benzodiazepines, or Barbiturates), unless recent use of prescription opiates or benzodiazepines were taken for management of acute symptoms (e.g., tooth extraction, recent surgery, or sleep);
- Use of experimental (investigational) drugs within the past 7 days;
- Use of psychiatric medications including antidepressants and anti-psychotics may be permitted if the condition is stable (study medical provider discretion).
- Use of opiates, benzodiazepines, and muscle relaxants (unless taken for sleep or acute symptoms such as tooth extraction or recent surgery) within the past 7 days (study medical provider discretion);
- Use of Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine patch, nicotine replacement therapy, clonidine or any other smoking cessation aid within the past 30 days;
- Use of cigars, pipes, Hookah, dissolvable nicotine, snuff, chewing tobacco, or e-cigarettes within the past 7 days;
- Diagnosis of alcohol abuse or dependence or self-report of consuming more than 6 drinks on one occasion more than one day per week;
- Significant adverse reaction to nicotine patch in the past;
- Current or recent participation (in the past 30 days) in another smoking treatment study at our Center or another research facility;
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Center for Smoking Cessation
Durham, North Carolina, 27705
About this study
The advent of electronic cigarette (e-cigarette) technologies represents one of the most significant developments in the last several decades, and provides a novel and promising strategy for substantially reducing the morbidity and mortality associated with smoking. However, serious concerns have been raised regarding the possibility that e-cigarettes will sustain a dependency on nicotine and that they may lead to continued use of conventional cigarettes known to be extremely harmful to health. Cigarette addiction critically involves a dependence on nicotine, but it is likely that other tobacco constituents contribute to dependence as well. Recent evidence suggests that non-nicotine tobacco alkaloids, or NNTAs (including anabasine, anatabine, nornicotine, and myosmine) may play a role in tobacco dependence. These alkaloids have been shown to augment the reinforcing effects of nicotine in animal models and to affect cravings in human smokers. E-cigarettes contain variable quantities of nicotine and NNTAs, but there is virtually no information available concerning the role of e-cigarette nicotine or NNTA content in influencing the concurrent use of cigarettes and e-cigarettes, when smokers attempt to switch from conventional combustible cigarettes to e-cigarettes. Additionally, it is not known whether the presence of nicotine and NNTAs in e- cigarettes may sustain dependence, making it difficult to relinquish these products. The proposed project will assess the acceptability, extent of switching behavior, and degree of dependence maintained when smokers are provided with e-cigarettes containing nicotine and NNTAs.
Read the detailed description
A single group of thirty smokers will be recruited for the study to provide initial data to inform follow-up randomized controlled trials.
Dependence and concurrent use of e-cigarettes and cigarettes will be assessed by a battery of self-report, biochemical, and behavioral indices. This is not a tobacco cessation study and there is no intent to use e-cigarettes as a smoking cessation treatment. Smokers will be asked to use the e-cigarettes instead of their regular cigarettes during the study. E-cigarettes will not be used for the purpose of reducing urges, withdrawal or nicotine dependence; and e-cigarettes will not be described or used as a medical device or therapy.
Specific Aim 1: To assess the extent of switching from combustible cigarettes to e-cigarettes delivering nicotine along with NNTAs.
Switching will be assessed by self-report diaries and by reductions in expired air carbon monoxide, an index of combustible cigarette use.
Specific Aim 2: To assess the acceptability of e-cigarettes delivering nicotine along with NNTAs.
Ratings of user satisfaction and other subjective effects will be collected from participants, for both their customary brand of cigarettes and the e-cigarette to be used.
Specific Aim 3: To determine the extent of dependence maintained during use of e-cigarettes delivering nicotine with NNTAs, as well as the relationship between dependence and self-reported use of cigarettes and e-cigarettes.
- Conditions
- Nicotine Dependence
- Being tested
- E-cigarettes
- Keywords
- Nicotine addiction, Cigarette smoking, E-cigarettes
- Medical subject headings
- Tobacco Use Disorder, Cigarette Smoking, Vaping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E-cigarettesCombination product
Also called Electronic Nicotine Delivery System (ENDS), e-cigs, electronic cigarettes
Participants will be asked to switch from cigarette use to use of e-cigarettes for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine + NNTAs | Experimental | Participants will be asked to switch from cigarette use to use of e-cigarettes for eight weeks. E-cigarette cartridges will contain tobacco extract with nicotine + NNTAs in a vehicle of propylene glycol and vegtable glycerin, with tobacco or menthol flavor matched to each participant's preference. The yields of nicotine and NNTAs will be in the range of typical commercial cigarettes. Receives: Combination Product: E-cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in expired air carbon monoxide (CO) to assess recent smoking
Self-reported changes in cigarette use from baseline to week 8, expressed as a percentage of baseline values, will be calculated, based on expired air carbon monoxide readings.
Measured: Weeks 1-8
Secondary outcomes (5)
Mean volume of e-cigarette solution used per day to assess e-cigarette use.
The mean volume of solution used per day (by measuring the content and number of pods returned) will be calculated for each week.
Measured: Weeks 1-8
Change in cigarette use, assessed by self-report in daily dairies
Self-reported changes in cigarette use from baseline to week 8, expressed as a percentage of baseline values, will be calculated, based on cigarette consumption recorded in daily diaries.
Measured: Weeks 1-8
E-cigarette use, assessed by self-report in daily dairies
The self-reported use of e-cigarette pods, based on daily diaries, will be totaled for each week.
Measured: Weeks 1-8
Change in Nicotine dependence
The change in level of nicotine dependence will be assessed by administering the Fagerstrom Test for Nicotine Dependence questionnaire, administered at baseline and at week 8.
Measured: Weeks 1-8.
Satisfaction ratings
The satisfaction of the experimental e-cigarette formulation will be assessed using the modified Cigarette Evaluation Questionnaire, with wording adapted to e-cigarettes.
Measured: Weeks 1-8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study start21 May 2021
- Primary completion13 Jan 2022
- Study completion13 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine DependenceStudies of the same condition, open and under way.
- More trials run by Duke 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jed Rose, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590393
- Sponsor's protocol ID
- Pro00059780
- Other IDs
- 1R01DA038554-01
- Acronym
- Ecig1
- Status last verified
- Feb 2024
- First submitted
- 27 Oct 2015
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Nicotine and Non-Nicotine Alkaloids in E-Cigarette Use and Dependence
- ClinicalTrials.gov ID
- NCT02590393
- Acronym / sponsor ID
- Ecig1 / Pro00059780
- Conditions
- Nicotine Dependence
- Keywords
- Nicotine addiction, Cigarette smoking, E-cigarettes
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 21 May 2021 (actual)
- Primary completion
- 13 Jan 2022 (actual)
- Study completion
- 13 Jan 2022 (actual)
- First posted
- 29 Oct 2015 (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 advent of electronic cigarette (e-cigarette) technologies represents one of the most significant developments in the last several decades, and provides a novel and promising strategy for substantially reducing the morbidity and mortality associated with smoking. However, serious concerns have been raised regarding the possibility that e-cigarettes will sustain a dependency on nicotine and that they may lead to continued use of conventional cigarettes known to be extremely harmful to health. Cigarette addiction critically involves a dependence on nicotine, but it is likely that other tobacco constituents contribute to dependence as well. Recent evidence suggests that non-nicotine tobacco alkaloids, or NNTAs (including anabasine, anatabine, nornicotine, and myosmine) may play a role in tobacco dependence. These alkaloids have been shown to augment the reinforcing effects of nicotine in animal models and to affect cravings in human smokers. E-cigarettes contain variable quantities of nicotine and NNTAs, but there is virtually no information available concerning the role of e-cigarette nicotine or NNTA content in influencing the concurrent use of cigarettes and e-cigarettes, when smokers attempt to switch from conventional combustible cigarettes to e-cigarettes. Additionally, it is not known whether the presence of nicotine and NNTAs in e- cigarettes may sustain dependence, making it difficult to relinquish these products. The proposed project will assess the acceptability, extent of switching behavior, and degree of dependence maintained when smokers are provided with e-cigarettes containing nicotine and NNTAs.
Detailed description
A single group of thirty smokers will be recruited for the study to provide initial data to inform follow-up randomized controlled trials.
Dependence and concurrent use of e-cigarettes and cigarettes will be assessed by a battery of self-report, biochemical, and behavioral indices. This is not a tobacco cessation study and there is no intent to use e-cigarettes as a smoking cessation treatment. Smokers will be asked to use the e-cigarettes instead of their regular cigarettes during the study. E-cigarettes will not be used for the purpose of reducing urges, withdrawal or nicotine dependence; and e-cigarettes will not be described or used as a medical device or therapy.
Specific Aim 1: To assess the extent of switching from combustible cigarettes to e-cigarettes delivering nicotine along with NNTAs.
Switching will be assessed by self-report diaries and by reductions in expired air carbon monoxide, an index of combustible cigarette use.
Specific Aim 2: To assess the acceptability of e-cigarettes delivering nicotine along with NNTAs.
Ratings of user satisfaction and other subjective effects will be collected from participants, for both their customary brand of cigarettes and the e-cigarette to be used.
Specific Aim 3: To determine the extent of dependence maintained during use of e-cigarettes delivering nicotine with NNTAs, as well as the relationship between dependence and self-reported use of cigarettes and e-cigarettes.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nicotine + NNTAs | Experimental | Combination Product: E-cigarettesParticipants will be asked to switch from cigarette use to use of e-cigarettes for eight weeks. E-cigarette cartridges will contain tobacco extract with nicotine + NNTAs in a vehicle of propylene glycol and vegtable glycerin, with tobacco or menthol flavor matched to each participant's preference. The yields of nicotine and NNTAs will be in the range of typical commercial cigarettes. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have no known serious medical conditions;
- Are 21-65 years old;
- Smoke an average of at least 10 cigarettes per day;
- Have smoked at least one cumulative year;
- Have an expired air CO reading of at least 10ppm;
Key exclusion criteria (28 listed)
- Actively seeking treatment for nicotine dependence;
- Uncontrolled high blood pressure (self-report);
- Coronary heart disease with symptoms (e.g., chest pain);
- Heart attack in the past year;
- Cardiac rhythm disorder (irregular heart rhythm with symptoms);
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 |
|---|---|---|
| E-cigarettesAlso: Electronic Nicotine Delivery System (ENDS), e-cigs, electronic cigarettesParticipants will be asked to switch from cigarette use to use of e-cigarettes for eight weeks. | Combination product | Nicotine + NNTAs |
Primary outcome
Change in expired air carbon monoxide (CO) to assess recent smoking
Time frame: Weeks 1-8
Self-reported changes in cigarette use from baseline to week 8, expressed as a percentage of baseline values, will be calculated, based on expired air carbon monoxide readings.
5 secondary outcomes
Mean volume of e-cigarette solution used per day to assess e-cigarette use.
Time frame: Weeks 1-8
Change in cigarette use, assessed by self-report in daily dairies
Time frame: Weeks 1-8
E-cigarette use, assessed by self-report in daily dairies
Time frame: Weeks 1-8
Change in Nicotine dependence
Time frame: Weeks 1-8.
Satisfaction ratings
Time frame: Weeks 1-8.
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 21 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Jed Rose, Ph.D. principal investigator
Duke 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 E-cigarettes in people with Nicotine Dependence, run by Duke 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 12 inclusion and 28 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 21 Feb 2024. 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.
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?
Change in expired air carbon monoxide (CO) to assess recent smoking (time frame: Weeks 1-8). 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 21 Feb 2024.