Varenicline for Treatment of E-cigarette Dependence

Varenicline is used to treat tobacco use dependence. It helps reduce cravings for tobacco use and decreases the pleasurable effects of cigarettes and other tobacco products. Varenicline has been proven to reduce the desire to smoke cigarettes. This study aims to test whether it shows a similar benefit for individuals who vape and are interested in quitting.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation
• Intervention / Treatment: Drug: Varenicline Tartrate; Drug: Placebo

Detailed Description

Varenicline is a highly efficacious FDA-approved smoking cessation pharmacotherapy. The aim of this study is to examine the effectiveness of varenicline for e-cigarette cessation medication for mono- e-cigarette use in combination with a minimal, self-guided behavior change booklet. This booklet will include general tips for e-cigarettes cessation and information about the free web-based e-cigarette cessation program sponsored by The Truth Initiative and Mayo called "This is Quitting". This study will have an 8-week treatment period and a 4-week follow-up phase. Participants will be randomized to receive an 8-week supply of varenicline or matching placebo (gel capsule filled with cellulose powder) in combination with the self-change booklet. The investigators hypothesize that participants who receive varenicline will have higher rates of e-cigarette cessation.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Lisa Fucito, PhD; Phone Number: 203-464-7850; Email: lisa.fucito@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Yale University
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• daily use of an e-cigarette containing nicotine (defined as use for at least 25 days out of the past month)
• use of an e-cigarette containing nicotine> 6 months
• have desire to quit e-cigarettes, are willing to set a quit date and maintain e-cigarette abstinence
• have daily access to a smartphone or have regular (daily) access/use of email
• live in South Carolina or Connecticut

Exclusion Criteria:

• Vulnerable Populations: Not be enrolling vulnerable populations, specifically pregnant women, children, prisoners, or institutionalized individuals
• The investigators will not enroll participants incapable of providing their own consent. The rationale will be provided to the individual as well as his or her family members.

Referrals for further evaluation, including urgent or emergent evaluation, will be made as needed and clinically warranted.

• exclude individuals with medical contraindications for varenicline use (i.e., severe renal impairment)
• exclude anyone currently using smoking cessation medications.
• Individuals will also be excluded if another household member is currently enrolled in the study.
• Individuals will be excluded if not proficient in English.
• Individuals will be excluded if they have smoked any combustible cigarettes in the past 6 months.
• Verification of Non-Pregnancy: Females ages <55 will be mailed a commercially available pregnancy test to verify non-pregnancy. Written confirmation of negative pregnancy test via REDCap will be required prior to enrollment in the trial. Participants are also informed that they should let us know if they become pregnant during the trial. Medications will not be sent until this verification is in place. These procedures are based on the Medical University of South Carolina Internal Review Board approved STARS protocol.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Varenicline + Self-Change Pamphlet; Days 1-3: 0.5mg study pill once per day; Days 4-7: 0.5mg study pill twice per day; Weeks 2-8: 1mg study pill twice per day in combination with a minimal, self-guided behavior change booklet. This booklet includes general tips for e-cigarettes cessation and information about the free web-based e-cigarette cessation program sponsored by The Truth Initiative and Mayo called "This is Quitting". This study will have an 8-week treatment period and a 4-week follow-up.	Drug: Varenicline Tartrate; Days 1-3: 0.5mg study pill once per day, Days 4-7: 0.5mg study pill twice per day, Weeks 2-8: 1mg study pill twice per day
Placebo Comparator: Placebo + Self-Change Pamphlet; Days 1-3: 0.5mg placebo pill once per day; Days 4-7: 0.5mg placebo pill twice per day; Weeks 2-8: 1mg placebo pill twice per day in combination with a minimal, self-guided behavior change booklet. This booklet includes general tips for e-cigarettes cessation and information about the free web-based e-cigarette cessation program sponsored by The Truth Initiative and Mayo called "This is Quitting". This study will have an 8-week treatment period and a 4-week follow-up.	Drug: Placebo; Days 1-3: 0.5mg pill once per day, Days 4-7: 0.5mg pill twice per day, Weeks 2-8: 1mg pill twice per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants Abstinent from vaping at week 8	Abstinence is defined as no vaping, not even a puff, every day for the last 7 days via self-report (i.e., 7 day point prevalent abstinence).	Week 8

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants Abstinent from vaping at week 12	Abstinence is defined as no vaping, not even a puff, every day for the last 7 days via self-report (i.e., 7 day point prevalent abstinence).	Week 12

Collaborators and Investigators

• Sponsor: Yale University
• Investigators: Principal Investigator: Lisa Fucito, Ph.D., Yale University; Principal Investigator: Benjamin Toll, Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2022
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: September 12, 2022
• First Submitted That Met QC Criteria: September 12, 2022
• First Posted (Actual): September 15, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2024
• Last Update Submitted That Met QC Criteria: April 23, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: e-cigarette
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Nicotinic Agonists; Cholinergic Agonists; Varenicline
• Other Study ID Numbers: 2000032740; 000 (Other Identifier: CTGTY)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes