Clinical trial NCT02628964: 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
Overall status: COMPLETED
Phase: NA
Conditions: Tobacco Use Disorder
Smoking
Keywords: smoking
cigarettes
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2015-12-11
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: Changes in the Number of Cigarettes Per Day (CPD)
timeFrame: Baseline up to 3 weeks
measure: Proportion of Participants Who Achieve 50% Reduction in Number of Cigarettes Per Day at 3 Weeks.
timeFrame: up to 3 weeks
Secondary outcomes:
measure: Percent of Participants in Each Arm Who Reported Side Effects
timeFrame: 3 weeks
measure: Number of Participants Using Additional Tobacco Products and/or Marijuana
timeFrame: Up to 12 weeks
measure: Percentage Satisfaction Rating for the E-cigarettes
timeFrame: 3 weeks
measure: Number of Nicotine Urges/Cravings
timeFrame: Up to 12 weeks
measure: Number of Participants Experiencing Withdrawal Symptoms
timeFrame: Up to 12 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Donna Shelley, MD
role: PRINCIPAL_INVESTIGATOR
References: