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Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy

Primary Purpose

Tobacco Use Disorder, Smoking

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

e-cigarettes

About this trial

This is an interventional supportive care trial for Tobacco Use Disorder focused on measuring smoking, cigarettes

Eligibility Criteria

21 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

New York University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

4.5% e-cig

0 mg e-cig

Arm Description

e-cigarettes with nicotine cartridges

e-cigarettes with placebo cartridges (0mg).

Outcomes

Primary Outcome Measures

Changes in the Number of Cigarettes Per Day (CPD)

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

Secondary Outcome Measures

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

Number of Participants Using Additional Tobacco Products and/or Marijuana

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

Number of Nicotine Urges/Cravings

Number of Participants Experiencing Withdrawal Symptoms

No data displayed because Outcome Measure has zero total participants analyzed.

Full Information

NCT ID

NCT02628964

First Posted

September 28, 2015

Last Updated

February 20, 2020

Sponsor

NYU Langone Health

1. Study Identification

Unique Protocol Identification Number

NCT02628964

Brief Title

Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy

Official Title

Assessing the Use of Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

May 2015 (undefined)

Primary Completion Date

March 26, 2018 (Actual)

Study Completion Date

March 26, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

NYU Langone Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tobacco Use Disorder, Smoking

Keywords

smoking, cigarettes

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

4.5% e-cig

Arm Type

Active Comparator

Arm Description

e-cigarettes with nicotine cartridges

Arm Title

0 mg e-cig

Arm Type

Placebo Comparator

Arm Description

e-cigarettes with placebo cartridges (0mg).

Intervention Type

Device

Intervention Name(s)

e-cigarettes

Intervention Description

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.

Primary Outcome Measure Information:

Title

Changes in the Number of Cigarettes Per Day (CPD)

Time Frame

Baseline up to 3 weeks

Title

Proportion of Participants Who Achieve 50% Reduction in Number of Cigarettes Per Day at 3 Weeks.

Description

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

Secondary Outcome Measure Information:

Title

Percent of Participants in Each Arm Who Reported Side Effects

Description

Percentage of participants who responded yes to a yes/no question about experiencing any side effects

Time Frame

3 weeks

Title

Number of Participants Using Additional Tobacco Products and/or Marijuana

Time Frame

Up to 12 weeks

Title

Percentage Satisfaction Rating for the E-cigarettes

Description

Percent of participants who reported either "Strongly Agree" or "Agree" to liking using e-cigarettes at 3-weeks

Time Frame

3 weeks

Title

Number of Nicotine Urges/Cravings

Time Frame

Up to 12 weeks

Title

Number of Participants Experiencing Withdrawal Symptoms

Description

No data displayed because Outcome Measure has zero total participants analyzed.

Time Frame

Up to 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Maximum Age & Unit of Time

35 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Donna Shelley, MD

Organizational Affiliation

NYU Langone Health

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York University School of Medicine

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

12. IPD Sharing Statement

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Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy

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