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

NCT04063267 | Completed Phase 2 DMC

• 1 other identifier: 18-00840
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Cigarette Smoking; Addiction; E Cig Use

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

E cigarettes

EXPERIMENTAL

Other: E cigarettes

Nicotine Replacement Therapy

ACTIVE COMPARATOR

Other: Nicotine Replacement Therapy

Interventions

E cigarettes OTHER

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

E cigarettes

Nicotine Replacement Therapy 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.

Nicotine Replacement Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Behavior, Addictive; Vaping

Interventions

Electronic Nicotine Delivery Systems; Nicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use; Compulsive Behavior; Impulsive Behavior

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture; Drug Therapy; Therapeutics

Study Officials

• Scott Sherman, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2019
• First Posted: August 21, 2019
• Study Start: October 27, 2020
• Primary Completion: June 1, 2024
• Study Completion: June 30, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• Access Criteria: Requests should be directed to Scott.Sherman@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)