Tobacco Use DisorderNCT02628964
Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy
A study testing e-cigarettes in people with Tobacco Use Disorder and Smoking, run by NYU Langone Health at 1 site in United States.
Trial summary
The purpose of this study is to examine the feasibility of using e-cigarettes as a method for harm reduction and the effects of providing e-cigarettes (or placebo e-cigarettes) on smoking outcomes. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Disorder, Smoking
- What is being tested?
- e-cigarettes
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to 26 Mar 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 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 21-35 years old
- daily smokers who smoke at least 10 cigarettes per day (CPD)
- interested in reducing CPDs
- able to provide consent
- Use a cell phone and are willing/able to receive and respond to daily text messages regarding their cigarette use and e-cigarette use on their cell phone
- Willing to use an e-cigarette for 3 weeks
Who cannot join
- pregnant and/or breast feeding
- currently using smoking cessation medications (including other forms of Nicotine Replacement Therapy (NRT), buproprion, or varenicline)
- enrolled in a smoking cessation program or another cessation trial
- have used an e-cigarette in the past 14 days
- have used any other tobacco products (pipe, cigar, cigarillos, snuff, chewing tobacco, rolling tobacco, or hookah/shisha) in the past 30 days
- score ≥7 (men) or ≥5 (women) on the Alcohol Use Disorders Identification Test (AUDIT-C),
- score ≥ 5 on the Drug Abuse Screening Test-10 (DAST)
- report having a history of asthma, other airways diseases, or heart disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Assessing the Use of Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy
The purpose of this study is to examine the feasibility of using e-cigarettes as a method for harm reduction and the effects of providing e-cigarettes (or placebo e-cigarettes) on smoking outcomes. Participants will be randomized to receive either e-cigarettes with nicotine cartridges or e-cigarettes with placebo cartridges, and followed for 3 weeks.
Read the detailed description
This pilot study will be a two-arm, randomized controlled trial. The investigator will randomize 40 participants into each intervention arm. Participants will be randomized to one of the two arms: e-cigarettes with nicotine cartridges or e-cigarettes with placebo cartridges (0mg). Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges. Participants will be asked to track their nicotine use via text message. All participants will receive a 20-30 minute behavioral counseling consultation with a trained tobacco counselor. Counselors will review each participant's smoking pattern and offer tailored behavioral and environmental change strategies including specific smoking reduction strategy options. Participants will be given a supply of e-cigarettes and followed for 3 weeks
- Conditions
- Tobacco Use Disorder, Smoking
- Being tested
- e-cigarettes
- Keywords
- smoking, cigarettes
- 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.
e-cigarettesDevice
Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges.
| Study group | Role | What they receive |
|---|---|---|
| 4.5% e-cig | Active comparator | e-cigarettes with nicotine cartridges Receives: Device: e-cigarettes |
| 0 mg e-cig | Placebo comparator | e-cigarettes with placebo cartridges (0mg). Receives: Device: e-cigarettes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the Number of Cigarettes Per Day (CPD)
Measured: Baseline up to 3 weeks
Proportion of Participants Who Achieve 50% Reduction in Number of Cigarettes Per Day at 3 Weeks.
Using the percent difference in number of cigarettes per day from baseline to 3-weeks, the proportion of participants who reduced their cigarette usage per day by 50% or greater
Measured: up to 3 weeks
Secondary outcomes (5)
Percent of Participants in Each Arm Who Reported Side Effects
Percentage of participants who responded yes to a yes/no question about experiencing any side effects
Measured: 3 weeks
Number of Participants Using Additional Tobacco Products and/or Marijuana
Measured: Up to 12 weeks
Percentage Satisfaction Rating for the E-cigarettes
Percent of participants who reported either "Strongly Agree" or "Agree" to liking using e-cigarettes at 3-weeks
Measured: 3 weeks
Number of Nicotine Urges/Cravings
Measured: Up to 12 weeks
Number of Participants Experiencing Withdrawal Symptoms
No data displayed because Outcome Measure has zero total participants analyzed.
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startMay 2015
- Primary completion26 Mar 2018
- Study completion26 Mar 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.
- Other trials for Tobacco Use DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Donna Shelley, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02628964
- Sponsor's protocol ID
- 14-01178
- Status last verified
- Feb 2020
- First submitted
- 28 Sep 2015
- Last updated
- 24 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Use of Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy
- ClinicalTrials.gov ID
- NCT02628964
- Acronym / sponsor ID
- 14-01178
- Conditions
- Tobacco Use Disorder, Smoking
- Keywords
- smoking, cigarettes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- 26 Mar 2018 (actual)
- Study completion
- 26 Mar 2018 (actual)
- First posted
- 11 Dec 2015 (estimated)
- Results
- Posted 24 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the feasibility of using e-cigarettes as a method for harm reduction and the effects of providing e-cigarettes (or placebo e-cigarettes) on smoking outcomes. Participants will be randomized to receive either e-cigarettes with nicotine cartridges or e-cigarettes with placebo cartridges, and followed for 3 weeks.
Detailed description
This pilot study will be a two-arm, randomized controlled trial. The investigator will randomize 40 participants into each intervention arm. Participants will be randomized to one of the two arms: e-cigarettes with nicotine cartridges or e-cigarettes with placebo cartridges (0mg). Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges. Participants will be asked to track their nicotine use via text message. All participants will receive a 20-30 minute behavioral counseling consultation with a trained tobacco counselor. Counselors will review each participant's smoking pattern and offer tailored behavioral and environmental change strategies including specific smoking reduction strategy options. Participants will be given a supply of e-cigarettes and followed for 3 weeks
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 4.5% e-cig | Active comparator | Device: e-cigarettese-cigarettes with nicotine cartridges |
| 0 mg e-cig | Placebo comparator | Device: e-cigarettese-cigarettes with placebo cartridges (0mg). |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 21-35 years old
- daily smokers who smoke at least 10 cigarettes per day (CPD)
- interested in reducing CPDs
- able to provide consent
- Use a cell phone and are willing/able to receive and respond to daily text messages regarding their cigarette use and e-cigarette use on their cell phone
Key exclusion criteria (8 listed)
- pregnant and/or breast feeding
- currently using smoking cessation medications (including other forms of Nicotine Replacement Therapy (NRT), buproprion, or varenicline)
- enrolled in a smoking cessation program or another cessation trial
- have used an e-cigarette in the past 14 days
- have used any other tobacco products (pipe, cigar, cigarillos, snuff, chewing tobacco, rolling tobacco, or hookah/shisha) in the past 30 days
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-cigarettesParticipants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges. | Device | 0 mg e-cig, 4.5% e-cig |
Primary outcome
Changes in the Number of Cigarettes Per Day (CPD)
Time frame: Baseline up to 3 weeks
Proportion of Participants Who Achieve 50% Reduction in Number of Cigarettes Per Day at 3 Weeks.
Time frame: up to 3 weeks
Using the percent difference in number of cigarettes per day from baseline to 3-weeks, the proportion of participants who reduced their cigarette usage per day by 50% or greater
5 secondary outcomes
Percent of Participants in Each Arm Who Reported Side Effects
Time frame: 3 weeks
Number of Participants Using Additional Tobacco Products and/or Marijuana
Time frame: Up to 12 weeks
Percentage Satisfaction Rating for the E-cigarettes
Time frame: 3 weeks
Number of Nicotine Urges/Cravings
Time frame: Up to 12 weeks
Number of Participants Experiencing Withdrawal Symptoms
Time frame: Up to 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Donna Shelley, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-cigarettes in people with Tobacco Use Disorder and Smoking, run by NYU Langone Health 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 6 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: finished, as of the sponsor's last update on 24 Feb 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2020). 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?
Changes in the Number of Cigarettes Per Day (CPD) (time frame: Baseline up to 3 weeks). The study lists 2 primary outcomes in all. 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 24 Feb 2020.