Varenicline for Treatment of E-cigarette Dependence

NCT05541497 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2000032740000
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Smoking Cessation

Keywords

e-cigarette

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants Abstinent From Vaping at Week 12

  Week 12

Study Arms (2)

Varenicline + Self-Change Pamphlet

EXPERIMENTAL

* 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

Placebo + Self-Change Pamphlet

PLACEBO COMPARATOR

* 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

Interventions

Varenicline Tartrate DRUG

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

Varenicline + Self-Change Pamphlet

Placebo DRUG

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

Placebo + Self-Change Pamphlet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead

Study Sites (2)

Yale University

New Haven, Connecticut, 06520, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Smoking Cessation; Vaping

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior; Smoking

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinoxalines

Results Point of Contact

• Title: Lisa Fucito, PhD: Associate Professor of Psychiatry; Director, Tobacco Treatment Service, Psychiatry
• Organization: Yale School of Medicine

lisa.fucito@yale.edu

(203) 688-1878

Study Officials

• Lisa Fucito, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

• Benjamin Toll

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 15, 2022
• Study Start: November 4, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2023
• Last Updated: December 2, 2024
• Results First Posted: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)