Tobacco Use DisorderNCT02004171
Electronic Cigarettes or Nicotine Inhaler for Smoking Cessation
A study testing electronic cigarette and nicotine inhaler in people with Tobacco Use Disorder, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
Electronic cigarettes have shown promise but have yet to proven effective for smoking cessation. This trial will evaluate the effectiveness of electronic cigarettes in smokers who are trying to quit smoking compared with a standard therapy, the nicotine inhaler. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder
- What is being tested?
- electronic cigarette and nicotine inhaler
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to Oct 2015
- Phase
- Interventional
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-60 year old
- Meet DSM-IV criteria for nicotine dependence
- Seeking treatment for smoking cessation
- Smoking at least 15 cigarettes per day
- Capable of giving informed consent and complying with study procedures
Who cannot join
- Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, and bipolar disorder or current diagnosis of major depressive disorder
- Current DSM-IV criteria for any other psychiatric disorder that may, according to the investigator's judgment, require either pharmacological or non- pharmacological intervention over the course of the study
- Currently receiving any treatment for nicotine dependence, including nicotine replacement therapy
- Pregnancy, lactation, or failure to use adequate contraception methods in women who are currently having sex with men
- Unstable medical condition, such as uncontrolled hypertension, angina, and oropharyngeal conditions which may make participation hazardous
- Current DSM-IV diagnosis of substance dependence, other than nicotine
- Use of cannabis or alcohol on more than 20 days in the past 30 days
- Risk for suicide
Trial locations and contacts
1 site in 1 country.
United States1 site
Substance Treatment and Research Services (STARS)
New York, New York, 10032
About this study
Official title: Electronic Nicotine Delivery Devices (ENDDs) or Nicotine Inhaler for Smoking Cessation
Electronic cigarettes have shown promise but have yet to proven effective for smoking cessation. This trial will evaluate the effectiveness of electronic cigarettes in smokers who are trying to quit smoking compared with a standard therapy, the nicotine inhaler. The investigators hypothesize that electronic cigarettes will be comparable to the nicotine inhaler in terms of smoking cessation.
Read the detailed description
Cigarette smoking remains the leading cause of preventable death and disease worldwide.
The purpose of this trial is to evaluate the effectiveness of electronic cigarettes for smoking cessation compared to a similar nicotine replacement therapy, the nicotine inhaler.
- Conditions
- Tobacco Use Disorder
- Being tested
- electronic cigarette, nicotine inhaler
- Keywords
- electronic cigarette, nicotine inhaler, smoking cessation
- Medical subject headings
- Tobacco Use Disorder, Vaping, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
electronic cigaretteOther
V2 Cigs with 24 mg nicotine cartridges
nicotine inhalerDrug
Also called Nicotrol inhaler
nicotine inhaler with 10 mg nicotine cartridges
| Study group | Role | What they receive |
|---|---|---|
| electronic cigarette | Experimental | electronic cigarette 24mg cartridges; 1-2 cartridges daily Receives: Other: electronic cigarette |
| nicotine inhaler | Active comparator | nicotine inhaler 10mg cartridge; max 16 cartridges daily Receives: Drug: nicotine inhaler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cigarettes smoked over 24 hours
Measured: 4 weeks
Secondary outcomes (3)
Symptoms of nicotine withdrawal
We will measure the incidence and severity of nicotine withdrawal symptoms, including irritability, anxiety, depressed mood and increased appetite.
Measured: 4 weeks
Benefits from smoking cessation
we will measure perceived benefits from smoking cessation including improved breathing, improved sense of taste and smell, and improved physical fitness.
Measured: 4 weeks
Adverse reaction to nicotine inhaler or electronic cigarette
we will assess for any possible side effect from the electronic cigarette or the nicotine inhaler, including irritation of the mouth and throat and cough.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionOct 2015
- Study completionOct 2015
Why it stopped: No participants enrolled. Changed requirements for studying e-cigarettes.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use DisorderStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Barney Vaughan, MD, Principal investigator, New York State Psychiatric Institute/Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004171
- Sponsor's protocol ID
- #6863 P50DA009236-20
- Other IDs
- P50DA009236-20
- Status last verified
- Nov 2014
- First submitted
- 25 Nov 2013
- Last updated
- 19 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Nicotine Delivery Devices (ENDDs) or Nicotine Inhaler for Smoking Cessation
- ClinicalTrials.gov ID
- NCT02004171
- Acronym / sponsor ID
- #6863 P50DA009236-20
- Conditions
- Tobacco Use Disorder
- Keywords
- electronic cigarette, nicotine inhaler, smoking cessation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No participants enrolled. Changed requirements for studying e-cigarettes.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Dec 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 9 Dec 2013 (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.
Electronic cigarettes have shown promise but have yet to proven effective for smoking cessation. This trial will evaluate the effectiveness of electronic cigarettes in smokers who are trying to quit smoking compared with a standard therapy, the nicotine inhaler. The investigators hypothesize that electronic cigarettes will be comparable to the nicotine inhaler in terms of smoking cessation.
Detailed description
Cigarette smoking remains the leading cause of preventable death and disease worldwide.
The purpose of this trial is to evaluate the effectiveness of electronic cigarettes for smoking cessation compared to a similar nicotine replacement therapy, the nicotine inhaler.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| electronic cigarette | Experimental | Other: electronic cigaretteelectronic cigarette 24mg cartridges; 1-2 cartridges daily |
| nicotine inhaler | Active comparator | Drug: nicotine inhalernicotine inhaler 10mg cartridge; max 16 cartridges daily |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 18-60 year old
- Meet DSM-IV criteria for nicotine dependence
- Seeking treatment for smoking cessation
- Smoking at least 15 cigarettes per day
- Capable of giving informed consent and complying with study procedures
Key exclusion criteria (8 listed)
- Lifetime history of DSM-IV diagnosis of schizophrenia, schizoaffective disorder, and bipolar disorder or current diagnosis of major depressive disorder
- Current DSM-IV criteria for any other psychiatric disorder that may, according to the investigator's judgment, require either pharmacological or non- pharmacological intervention over the course of the study
- Currently receiving any treatment for nicotine dependence, including nicotine replacement therapy
- Pregnancy, lactation, or failure to use adequate contraception methods in women who are currently having sex with men
- Unstable medical condition, such as uncontrolled hypertension, angina, and oropharyngeal conditions which may make participation hazardous
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 |
|---|---|---|
| electronic cigaretteV2 Cigs with 24 mg nicotine cartridges | Other | electronic cigarette |
| nicotine inhalerAlso: Nicotrol inhalernicotine inhaler with 10 mg nicotine cartridges | Drug | nicotine inhaler |
Primary outcome
Cigarettes smoked over 24 hours
Time frame: 4 weeks
3 secondary outcomes
Symptoms of nicotine withdrawal
Time frame: 4 weeks
Benefits from smoking cessation
Time frame: 4 weeks
Adverse reaction to nicotine inhaler or electronic cigarette
Time frame: 4 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2016.
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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.
Barney Vaughan, MD principal investigator
New York State Psychiatric Institute/Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing electronic cigarette and nicotine inhaler in people with Tobacco Use Disorder, run by New York State Psychiatric Institute 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 5 inclusion and 8 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: withdrawn, as of the sponsor's last update on 19 Oct 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. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Cigarettes smoked over 24 hours (time frame: 4 weeks). 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 19 Oct 2016; AzTrials last refreshed its copy on 3 Nov 2026.