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

NCT ID: NCT04063267

Last Updated: 2024-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-27

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Cigarette Smoking Addiction E Cig Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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E cigarettes

Group Type EXPERIMENTAL

E cigarettes

Intervention Type OTHER

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

Nicotine Replacement Therapy

Group Type ACTIVE_COMPARATOR

Nicotine Replacement Therapy

Intervention Type OTHER

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.

Interventions

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E cigarettes

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott Sherman, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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NYU Langone Health

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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18-00840

Identifier Type: -

Identifier Source: org_study_id