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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02628964
• Other study ID #: 14-01178
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: March 26, 2018

Study information

• Verified date: February 2020
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Participants will be randomized to receive either e-cigarettes with nicotine cartridges or e-cigarettes with placebo cartridges, and followed for 3 weeks.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 26, 2018
• Est. primary completion date: March 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking
• Tobacco Use Disorder

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in the Number of Cigarettes Per Day (CPD)		Baseline up to 3 weeks
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	up to 3 weeks
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	3 weeks
Secondary	Number of Participants Using Additional Tobacco Products and/or Marijuana		Up to 12 weeks
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	3 weeks
Secondary	Number of Nicotine Urges/Cravings		Up to 12 weeks
Secondary	Number of Participants Experiencing Withdrawal Symptoms	No data displayed because Outcome Measure has zero total participants analyzed.	Up to 12 weeks