Back to resultsElectronic Cigarettes as a Harm Reduction Strategy in Individuals With Substance Use Disorder
Primary Purpose
Cigarette Smoking, Addiction, E Cig Use
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
E cigarettes
Nicotine Replacement Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Cigarette Smoking
Eligibility Criteria
Inclusion Criteria:
- smokes at least 10 cigarettes per day
- meet DSM-V AUD and/or OUD within the past year, interested in reducing CPDs
- able to provide consent
- use a cell phone, are willing/able to receive and respond to daily text messages regarding their cigarette use and e-cigarette use on their cell phone
- provide one additional contact, and are willing to use an e-cigarette for 3 weeks.
Exclusion Criteria:
- pregnant and/or breast feeding (self-reported)
- currently using smoking cessation medications (including other forms of NRT, buproprion, or varenicline)
- enrolled in a smoking cessation program or another cessation tria
- 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
- report having a history of asthma, other airways diseases, or heart disease.
Sites / Locations
- NYU Langone HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
E cigarettes
Nicotine Replacement Therapy
Arm Description
Outcomes
Primary Outcome Measures
Proportion of participants who achieve 50% reduction in CPD at 3 weeks.
proportion of participants who achieve 50% reduction in CPD at 3 weeks.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04063267
Brief Title
Electronic Cigarettes as a Harm Reduction Strategy in Individuals With Substance Use Disorder
Official Title
Electronic Cigarettes as a Harm Reduction Strategy in Individuals With Substance Use Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 27, 2020 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
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
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients in addiction treatment have exceptionally higher rate of cigarette smoking and very low quit rates compared to the general population. 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 among patients in addiction treatment.
Detailed Description
Electronic nicotine delivery devices often referred to as e-cigarettes, are battery-powered devices that deliver vaporized nicotine when inhaled. Corresponding with the growth in media attention, marketing and promotion, awareness and use of e-cigarettes has increased dramatically. A large proportion of those using e-cigarettes use them to reduce the number of cigarettes they are smoking or to help them quit. Use of an e-cigarette by smokers unwilling or unable to stop smoking completely might be a good approach to reducing cigarette consumption as the e-cigarette imitates some behavioral aspects of cigarette smoking and contains nicotine. Moreover, the few existing studies on the effect of e-cigarettes on tobacco withdrawal and craving suggest promising potential to assist smokers in coping with smoking urges and decreasing cigarette use.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cigarette Smoking, Addiction, E Cig Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
E cigarettes
Arm Type
Experimental
Arm Title
Nicotine Replacement Therapy
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
E cigarettes
Intervention Description
Participants will be encouraged to substitute e-cigarettes for combustible cigarettes in order to reduce nicotine withdrawal symptoms
Intervention Type
Other
Intervention Name(s)
Nicotine Replacement Therapy
Intervention Description
Nicotine patches and gum to last them the first week based on their baseline recorded smoking. Participants will be advised to use both a 21 mg nicotine patch and 4 mg nicotine for cravings.
Primary Outcome Measure Information:
Title
Proportion of participants who achieve 50% reduction in CPD at 3 weeks.
Description
proportion of participants who achieve 50% reduction in CPD at 3 weeks.
Time Frame
3 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
smokes at least 10 cigarettes per day
meet DSM-V AUD and/or OUD within the past year, interested in reducing CPDs
able to provide consent
use a cell phone, are willing/able to receive and respond to daily text messages regarding their cigarette use and e-cigarette use on their cell phone
provide one additional contact, and are willing to use an e-cigarette for 3 weeks.
Exclusion Criteria:
pregnant and/or breast feeding (self-reported)
currently using smoking cessation medications (including other forms of NRT, buproprion, or varenicline)
enrolled in a smoking cessation program or another cessation tria
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
report having a history of asthma, other airways diseases, or heart disease.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omar El Shahawy
Phone
804-218-8270
Email
Omar.ElShahawy@nyulangone.org
First Name & Middle Initial & Last Name or Official Title & Degree
Kaitlyn Gee
Phone
646-501-3571
Email
Kaitlyn.Gee@nyulangone.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Sherman, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Health
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meghan Durr, MPH
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
IPD Sharing Time Frame
Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
IPD Sharing Access Criteria
Requests should be directed to Scott.Sherman@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Electronic Cigarettes as a Harm Reduction Strategy in Individuals With Substance Use Disorder
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