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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Tobacco Use Disorder, Smoking

Intervention / Treatment
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* Device: e-cigarettes


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 4.5% e-cig<br>e-cigarettes with nicotine cartridges | Device: e-cigarettes<br>* 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.<br>|
| Placebo Comparator: 0 mg e-cig<br>e-cigarettes with placebo cartridges (0mg). | Device: e-cigarettes<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Number of Participants Using Additional Tobacco Products and/or Marijuana |  | Up to 12 weeks | 
| 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 | 
| Number of Nicotine Urges/Cravings |  | Up to 12 weeks | 
| Number of Participants Experiencing Withdrawal Symptoms | No data displayed because Outcome Measure has zero total participants analyzed. | Up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking, cigarettes