Clinical Trials Directory

Trials / Completed

CompletedNCT04063267

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
48 (actual)
Sponsor
NYU Langone Health · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERE cigarettesParticipants will be encouraged to substitute e-cigarettes for combustible cigarettes in order to reduce nicotine withdrawal symptoms
OTHERNicotine Replacement TherapyNicotine 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.

Timeline

Start date
2020-10-27
Primary completion
2024-06-01
Completion
2024-06-30
First posted
2019-08-21
Last updated
2024-12-20

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04063267. Inclusion in this directory is not an endorsement.