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

Sponsor
NYU Langone Health (Other)
Overall Status
Recruiting
CT.gov ID
NCT04063267
Collaborator
(none)
240
1
2
38.1
6.3

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: E cigarettes
  • Other: Nicotine Replacement Therapy
Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Electronic Cigarettes as a Harm Reduction Strategy in Individuals With Substance Use Disorder
Actual Study Start Date :
Oct 27, 2020
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: E cigarettes

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

Active Comparator: Nicotine Replacement Therapy

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.

Outcome Measures

Primary Outcome Measures

  1. Proportion of participants who achieve 50% reduction in CPD at 3 weeks. [3 Weeks]

    proportion of participants who achieve 50% reduction in CPD at 3 weeks.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 NYU Langone Health New York New York United States 10016

Sponsors and Collaborators

  • NYU Langone Health

Investigators

  • Principal Investigator: Scott Sherman, MD, NYU Langone Health

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
NYU Langone Health
ClinicalTrials.gov Identifier:
NCT04063267
Other Study ID Numbers:
  • 18-00840
First Posted:
Aug 21, 2019
Last Update Posted:
Aug 10, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 10, 2022