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

NCT02628964 | Completed Results FDA Device

• 1 other identifier: 14-01178
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Tobacco Use Disorder; Smoking

Keywords

smoking; cigarettes

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  up to 3 weeks

Secondary Outcomes (5)

• Percent of Participants in Each Arm Who Reported Side Effects

  3 weeks

• Number of Participants Using Additional Tobacco Products and/or Marijuana

  Up to 12 weeks

• Percentage Satisfaction Rating for the E-cigarettes

  3 weeks

• Number of Nicotine Urges/Cravings

  Up to 12 weeks

• Number of Participants Experiencing Withdrawal Symptoms

  Up to 12 weeks

Study Arms (2)

4.5% e-cig

ACTIVE COMPARATOR

e-cigarettes with nicotine cartridges

Device: e-cigarettes

0 mg e-cig

PLACEBO COMPARATOR

e-cigarettes with placebo cartridges (0mg).

Device: e-cigarettes

Interventions

e-cigarettes DEVICE

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.

0 mg e-cig; 4.5% e-cig

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavior

Results Point of Contact

• Title: Donna Shelley, MD MPH
• Organization: NYU Langone Health

donna.shelley@nyulangone.org

917-494-4210

Study Officials

• Donna Shelley, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2015
• First Posted: December 11, 2015
• Study Start: May 1, 2015
• Primary Completion: March 26, 2018
• Study Completion: March 26, 2018
• Last Updated: February 24, 2020
• Results First Posted: February 24, 2020

Record last verified: 2020-02

Locations

US (1)