Nicotine Dependence, CigarettesPhase 2ENDS-SwitchNCT03492463
The Role of Nicotine Dose and Route of Delivery in Affecting Adoption of E-cigarettes and Reducing Exposure to Toxic Combustion Products
A Phase 2 study testing Nicotine patch, E-cigarettes and Non-nicotine e-cigarettes in people with Nicotine Dependence, Cigarettes, run by Duke University at 1 site in United States.
Trial summary
This study plans to investigate whether using electronic cigarettes (e-cigarettes) or skin patches containing nicotine affects switching from smoking conventional combustible (burning) cigarettes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nicotine Dependence, Cigarettes
- What is being tested?
- Nicotine patch, E-cigarettes and Non-nicotine e-cigarettes
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Aug 2018to 31 May 2021
- Phase
- Phase 2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- Have a body weight of > 110 lbs. (50 kg) and ≤ 300 lbs. (136 kg);
- Are able to read and understand English;
- Potential subjects of child bearing potential 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:
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- 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;
- Use of exclusionary medications.
Who cannot join
- Seeking treatment for nicotine dependence.
- Hypertension - systolic BP > 160 mm Hg, diastolic BP > 100 mm Hg. Individuals with a history of hypertension may be allowed to participate in the study if the study physician or medical provider determines that the condition is stable and will not jeopardize the individual's safety.
- Hypotension (with symptoms) - systolic BP < 90 mm Hg, diastolic BP < 60 mm Hg.
- Coronary heart disease with symptoms (e.g., chest pain)
- Heart attack in the past year
- Cardiac rhythm disorder (irregular heart rhythm with symptoms)
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- Chest pain in the last month (unless history indicates a non-cardiac source)
- Symptomatic heart disorder such as heart failure
- Advanced liver or kidney disease that requires medication or dialysis, paracentesis
- Major gastrointestinal illness (e.g. Celiac disease, Crohn's dx Ulcerative Colitis)
- 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
- Problems giving blood samples
- Diabetes with insulin use or with HbA1C over 7%
- Current cancer or treatment for cancer in the past six months (except basal or squa-mous cell skin cancer)
- HIV, Hepatitis B, or Hepatitis C
- History of Tuberculosis or recent positive purified protein derivative (PPD)
- Other major medical condition (as determined by study physician)
- Currently symptomatic psychiatric disease (as determined by study physician)
- Psychosis, bipolar disorder, or psychiatric hospitalization within the past 12 months
- Suicidal ideation (thinking about ways to commit suicide) (within the past 12 months) or a lifetime occurrence of attempted suicide;
- Current depression - The Patient Health Questionnaire PHQ-9 for Depression will be used to screen for current (within 2 weeks) depression. Potential subjects who score >9 (or who score >0 on item #9 ("Thoughts that you would be better off dead, or of hurting yourself in some way") will be excluded from study participation, and, at the discretion of the study physician, referred to appropriate psychiatric treatment;
- Pregnant or nursing mothers
- Use (within the past 30 days) of:
- Illegal drugs (or if the urine drug screen is positive for tetrahydrocannabinol (THC), Cocaine, Amphetamine, Opiates, Methamphetamines, phencyclidine (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);
- Experimental (investigational) drugs;
- Psychiatric medications including antidepressants (selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressant (TCAs), monoamine oxidase inhibitors (MAOIs), St. John's Wort), lithium, anti-psychotics or any other medications that are known to affect smoking cessation (e.g. clonidine);
- Phentermine, triptans, tryptophan, linezolid, dextromethorphan, opiates (unless taken for management of acute symptoms), tramadol, or dopamine agonists;
- Any agents that have documented correlation with increased incidence of valvulopathy and/or pulmonary hypertension (e.g., cyproheptadine, trazodone, nefazodone, amoxapine, tricyclic antidepressants, mirtazapine, pergolide, ergotamine, methysergide) (or anticipated use during the study);
- Wellbutrin, bupropion, Zyban, Chantix, varenicline, nicotine patch, nicotine replacement therapy or any other smoking cessation aid;
- Use of cigars, cigarillos, pipes, Hookah, dissolvable nicotine, snuff, chewing tobacco, or e-cigarettes
- Concurrent use of a serotonergic agent/combination associated with severe serotonin syndrome (within the past 30 days)
- Use of cigars, cigarillos, pipes, Hookah, dissolvable nicotine, snuff, chewing tobacco, or e-cigarettes within the past 30 days
- Self-report of consuming more than 6 alcoholic drinks on 1 or more days per week
- Significant adverse reaction to nicotine patch in the past
- Current participation or recent participation (in the past 30 days) in another smoking study at our Center or another research facility
- Current participation in another research study
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Center for Smoking Cessation
Durham, North Carolina, 27705
About this study
This study plans to investigate whether using electronic cigarettes (e-cigarettes) or skin patches containing nicotine affects switching from smoking conventional combustible (burning) cigarettes.
Read the detailed description
This study proposes to assess the relative role of nicotine dose and route of delivery in affecting successful switching from combustible cigarettes to e-cigarettes, as well as concomitant reductions in ad libitum cigarette smoking and exposure to harmful and potentially harmful constituents of combustion. The strategy will be to assess adoption of e-cigarette use and concomitant reduction in ad libitum smoking of subjects' usual brands of cigarettes over an 8-week period, during which they will receive nicotine or non-nicotine e-cigarettes, and nicotine skin patches. The nicotine patches will not be used as a therapeutic treatment in this study, but rather as a way to manipulate the nicotine dose, while varying the rate and route of nicotine delivery. Behavioral or "habit" aspects of e-cigarette use will be controlled for by the groups receiving non-nicotine e-cigarettes. Initially the study design included placebo patch control conditions, but due to limitations in budget and period of support, enrollment in these these arms was discontinued. All participants currently receive active nicotine patches.
- Conditions
- Nicotine Dependence, Cigarettes
- Being tested
- Nicotine patch, Placebo patch, E-cigarettes, Non-nicotine e-cigarettes
- Keywords
- Nicotine addiction, Cigarette smoking, Nicotine patches, 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.
Nicotine patchDrug
Also called NicoDerm
Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
Placebo patchOther
Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
E-cigarettesOther
Also called Electronic Nicotine Delivery System (ENDS), e-cigs, electronic cigarettes
Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
Non-nicotine e-cigarettesOther
Also called Electronic Nicotine Delivery System (ENDS), e-cigs, electronic cigarettes
Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine e-cigs + Nicotine patches | Active comparator | Participants will receive e-cigarettes containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks. Receives: Drug: Nicotine patch; Other: E-cigarettes |
| Non-nicotine e-cigs + Nicotine patches | Active comparator | Participants will receive e-cigarettes not containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks. Receives: Drug: Nicotine patch; Other: Non-nicotine e-cigarettes |
| Nicotine e-cigs + Placebo patches | Active comparator | Participants will receive e-cigarettes containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks. Receives: Other: Placebo patch; Other: E-cigarettes |
| Non-nicotine e-cigs + Placebo patches | Placebo comparator | Participants will receive e-cigarettes not containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks. Receives: Other: Placebo patch; Other: Non-nicotine e-cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expired Air Carbon Monoxide (CO) to Assess Recent Smoking
The effects of e-cigarette nicotine content and patch nicotine content on the concurrent use of conventional cigarettes will be assessed by comparing the groups on the expired air carbon monoxide (CO) measured at the end of the exposure period (Week 8).
Measured: Week 8
Secondary outcomes (3)
Cigarette Use, Assessed by Self-report in Daily Dairies
The effects of e-cigarette nicotine content and patch nicotine content on the concurrent use of conventional cigarettes will be assessed by comparing the groups on self-report of cigarette consumption on daily diaries (for week 8 only, average cigarettes smoked per day).
Measured: Week 8
E-cigarette Use, Assessed by Self-report in Daily Dairies
The effects of e-cigarette nicotine content and patch nicotine content on the concurrent use of e-cigarettes will be assessed by comparing the groups on self-report of e-cigarette use on daily diaries (for week 8 only).
Measured: Week 8
Total Urinary 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)
The effects of e-cigarette nicotine content and patch nicotine content on the concurrent use of conventional cigarettes will be assessed by comparing the groups on total urinary NNAL, a metabolite of the tobacco-specific carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), at the end of week 8.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start6 Aug 2018
- Primary completion31 May 2021
- Study completion31 May 2021
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.
- Other trials for Nicotine Dependence, CigarettesStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 94 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 E. Rose, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03492463
- Sponsor's protocol ID
- Pro00084132
- Other IDs
- P50DA027840-07
- Acronym
- ENDS-Switch
- Status last verified
- Jan 2023
- First submitted
- 3 Apr 2018
- Last updated
- 8 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Nicotine Dose and Route of Delivery in Affecting Adoption of E-cigarettes and Reducing Exposure to Toxic Combustion Products
- ClinicalTrials.gov ID
- NCT03492463
- Acronym / sponsor ID
- ENDS-Switch / Pro00084132
- Conditions
- Nicotine Dependence, Cigarettes
- Keywords
- Nicotine addiction, Cigarette smoking, Nicotine patches, E-cigarettes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 6 Aug 2018 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 10 Apr 2018 (actual)
- Results
- Posted 28 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study plans to investigate whether using electronic cigarettes (e-cigarettes) or skin patches containing nicotine affects switching from smoking conventional combustible (burning) cigarettes.
Detailed description
This study proposes to assess the relative role of nicotine dose and route of delivery in affecting successful switching from combustible cigarettes to e-cigarettes, as well as concomitant reductions in ad libitum cigarette smoking and exposure to harmful and potentially harmful constituents of combustion. The strategy will be to assess adoption of e-cigarette use and concomitant reduction in ad libitum smoking of subjects' usual brands of cigarettes over an 8-week period, during which they will receive nicotine or non-nicotine e-cigarettes, and nicotine skin patches. The nicotine patches will not be used as a therapeutic treatment in this study, but rather as a way to manipulate the nicotine dose, while varying the rate and route of nicotine delivery. Behavioral or "habit" aspects of e-cigarette use will be controlled for by the groups receiving non-nicotine e-cigarettes. Initially the study design included placebo patch control conditions, but due to limitations in budget and period of support, enrollment in these these arms was discontinued. All participants currently receive active nicotine patches.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Nicotine e-cigs + Nicotine patches | Active comparator | Drug: Nicotine patch, Other: E-cigarettesParticipants will receive e-cigarettes containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks. |
| Non-nicotine e-cigs + Nicotine patches | Active comparator | Drug: Nicotine patch, Other: Non-nicotine e-cigarettesParticipants will receive e-cigarettes not containing nicotine and nicotine patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks. |
| Nicotine e-cigs + Placebo patches | Active comparator | Other: Placebo patch, Other: E-cigarettesParticipants will receive e-cigarettes containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks. |
| Non-nicotine e-cigs + Placebo patches | Placebo comparator | Other: Placebo patch, Other: Non-nicotine e-cigarettesParticipants will receive e-cigarettes not containing nicotine and placebo patches (21mg/24hr) and will be asked to switch from cigarette use to use of the study e-cigarettes for eight weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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;
- Have a body weight of > 110 lbs. (50 kg) and ≤ 300 lbs. (136 kg);
- Are able to read and understand English;
Key exclusion criteria (40 listed)
- Seeking treatment for nicotine dependence.
- Hypertension - systolic BP > 160 mm Hg, diastolic BP > 100 mm Hg. Individuals with a history of hypertension may be allowed to participate in the study if the study physician or medical provider determines that the condition is stable and will not jeopardize the individual's safety.
- Hypotension (with symptoms) - systolic BP < 90 mm Hg, diastolic BP < 60 mm Hg.
- Coronary heart disease with symptoms (e.g., chest pain)
- Heart attack in the past year
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 |
|---|---|---|
| Nicotine patchAlso: NicoDermParticipants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks. | Drug | Nicotine e-cigs + Nicotine patches, Non-nicotine e-cigs + Nicotine patches |
| Placebo patchParticipants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks. | Other | Nicotine e-cigs + Placebo patches, Non-nicotine e-cigs + Placebo patches |
| E-cigarettesAlso: Electronic Nicotine Delivery System (ENDS), e-cigs, electronic cigarettesParticipants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks. | Other | Nicotine e-cigs + Nicotine patches, Nicotine e-cigs + Placebo patches |
| Non-nicotine e-cigarettesAlso: Electronic Nicotine Delivery System (ENDS), e-cigs, electronic cigarettesParticipants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks. | Other | Non-nicotine e-cigs + Nicotine patches, Non-nicotine e-cigs + Placebo patches |
Primary outcome
Expired Air Carbon Monoxide (CO) to Assess Recent Smoking
Time frame: Week 8
The effects of e-cigarette nicotine content and patch nicotine content on the concurrent use of conventional cigarettes will be assessed by comparing the groups on the expired air carbon monoxide (CO) measured at the end of the exposure period (Week 8).
3 secondary outcomes
Cigarette Use, Assessed by Self-report in Daily Dairies
Time frame: Week 8
E-cigarette Use, Assessed by Self-report in Daily Dairies
Time frame: Week 8
Total Urinary 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL)
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 E. 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 2 study testing Nicotine patch, E-cigarettes and Non-nicotine e-cigarettes in people with Nicotine Dependence, Cigarettes, 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 40 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 8 Feb 2023. 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 28 Jun 2022). 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?
Expired Air Carbon Monoxide (CO) to Assess Recent Smoking (time frame: Week 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 8 Feb 2023.