Smoking, Tobacco Use Disorder
Conditions
Keywords
smoking, cigarettes
Brief 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. 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
Interventions
DEVICEe-cigarettes
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.
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
21 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the Number of Cigarettes Per Day (CPD) | Baseline up to 3 weeks | — |
| Proportion of Participants Who Achieve 50% Reduction in Number of Cigarettes Per Day at 3 Weeks. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage Satisfaction Rating for the E-cigarettes | 3 weeks | Percent of participants who reported either Strongly Agree or Agree to liking using e-cigarettes at 3-weeks |
| Percent of Participants in Each Arm Who Reported Side Effects | 3 weeks | Percentage of participants who responded yes to a yes/no question about experiencing any side effects |
| Number of Participants Experiencing Withdrawal Symptoms | Up to 12 weeks | No data displayed because Outcome Measure has zero total participants analyzed. |
| Number of Nicotine Urges/Cravings | Up to 12 weeks | — |
| Number of Participants Using Additional Tobacco Products and/or Marijuana | Up to 12 weeks | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 4.5% E-cig e-cigarettes with nicotine cartridges
e-cigarettes: 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. | 50 |
| 0 mg E-cig e-cigarettes with placebo cartridges (0mg).
e-cigarettes: 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. | 49 |
| Total | 99 |
Baseline characteristics
| Characteristic | 4.5% E-cig | 0 mg E-cig | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 49 Participants | 99 Participants |
| Race/Ethnicity, Customized Hispanic of any race | 11 Participants | 13 Participants | 24 Participants |
| Race/Ethnicity, Customized Non-Hispanic African American/black | 16 Participants | 14 Participants | 30 Participants |
| Race/Ethnicity, Customized Non-Hispanic white | 17 Participants | 12 Participants | 29 Participants |
| Race/Ethnicity, Customized Other | 1 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Other non-Hispanic | 5 Participants | 9 Participants | 14 Participants |
| Region of Enrollment United States | 50 participants | 49 participants | 99 participants |
| Sex: Female, Male Female | 16 Participants | 16 Participants | 32 Participants |
| Sex: Female, Male Male | 34 Participants | 33 Participants | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 49 |
| other Total, other adverse events | 0 / 50 | 0 / 49 |
| serious Total, serious adverse events | 0 / 50 | 0 / 49 |
Outcome results
Primary
Changes in the Number of Cigarettes Per Day (CPD)
Time frame: Baseline up to 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 4.5% E-cig | Changes in the Number of Cigarettes Per Day (CPD) | 8.2 cigarettes per day (CPD) | Standard Deviation 5.1 |
| 0 mg E-cig | Changes in the Number of Cigarettes Per Day (CPD) | 7.3 cigarettes per day (CPD) | Standard Deviation 4.9 |
Primary
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
Time frame: up to 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 4.5% E-cig | Proportion of Participants Who Achieve 50% Reduction in Number of Cigarettes Per Day at 3 Weeks. | .7 proportion of participants |
| 0 mg E-cig | Proportion of Participants Who Achieve 50% Reduction in Number of Cigarettes Per Day at 3 Weeks. | .49 proportion of participants |
Secondary
Number of Nicotine Urges/Cravings
Time frame: Up to 12 weeks
Population: no data were collected for this Outcome Measure
Secondary
Number of Participants Experiencing Withdrawal Symptoms
No data displayed because Outcome Measure has zero total participants analyzed.
Time frame: Up to 12 weeks
Population: no data were collected for this Outcome Measure
Secondary
Number of Participants Using Additional Tobacco Products and/or Marijuana
Time frame: Up to 12 weeks
Population: no data were collected for this Outcome Measure
Secondary
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
Time frame: 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 4.5% E-cig | Percentage Satisfaction Rating for the E-cigarettes | 65 percentage of participants |
| 0 mg E-cig | Percentage Satisfaction Rating for the E-cigarettes | 71.8 percentage of participants |
Secondary
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
Time frame: 3 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 4.5% E-cig | Percent of Participants in Each Arm Who Reported Side Effects | 22.5 percentage of participants |
| 0 mg E-cig | Percent of Participants in Each Arm Who Reported Side Effects | 10.5 percentage of participants |