Electronic Cigarettes as a Harm Reduction Strategy in Individuals With Substance Use Disorder

Cigarette Smoking Clinical Trial

Official title:

Electronic Cigarettes as a Harm Reduction Strategy in Individuals With Substance Use Disorder

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04063267
• Other study ID #: 18-00840
• Status: Recruiting
• Phase: Phase 2
• Start date: October 27, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: NYU Langone Health
• Contact: Omar El Shahawy
• Phone: 804-218-8270
• Email: Omar.ElShahawy[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: June 30, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Addiction
• Cigarette Smoking
• E Cig Use
• Substance-Related Disorders

Intervention

Device:
• E cigarettes
Participants will be encouraged to substitute e-cigarettes for combustible cigarettes in order to reduce nicotine withdrawal symptoms

Other:
• Nicotine Replacement Therapy
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.

Locations

Country	Name	City	State
United States	NYU Langone Health	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	Proportion of participants who achieve 50% reduction in CPD at 3 weeks.	proportion of participants who achieve 50% reduction in CPD at 3 weeks.	3 Weeks