Feasibility of Treatment for Vaping Cessation

NCT04317300 | Withdrawn Early Phase 1 FDA Drug

• 1 other identifier: 19-011437
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Researchers are gathering information on the feasibility of treating e-cigarette users with 12-weeks of varenicline (Chantix®) in assisting with stopping the use of e-cigarettes.

Conditions

Vaping

Keywords

electronic cigarettes; vaping; e-cigarettes

Outcome Measures

Primary Outcomes (1)

• Rate of e-cigarette abstinence after 12 weeks of treatment with varenicline plus brief behavioral therapy as an aid to stop vaping

  The rate of self reported e-cigarette abstinence verified biochemically with nicotine and nicotine metabolites in urine will be assessed at the end of a 12-week course of varenicline plus brief behavioral therapy.

  12 weeks

Study Arms (1)

E-cigarette users

EXPERIMENTAL

Participants who are regular users of e-cigarettes will be treated with a 12 week course of varenicline for stopping vaping.

Drug: Varenicline; Other: brief behavioral therapy

Interventions

Varenicline DRUG

Dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 11 weeks of treatment.

Also known as: Chantix®

E-cigarette users

brief behavioral therapy OTHER

brief behavioral therapy

E-cigarette users

Eligibility Criteria

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

You may qualify if:

• ≥18 years and ≤65 years of age;
• No use of tobacco in any form (except E-cigarettes) in the past 3 months;
• currently using e-cigarettes

You may not qualify if:

• Current moderate or severe depression
• Use of any treatments for tobacco dependence within the past 30 days;
• Recent history (past 3 months) of abuse of, or dependence on, a substance other than nicotine;
• Women who are pregnant or lactating, or who are of childbearing potential and are likely to become pregnant during the medication phase, or a male who is able to father a child, and are not willing to use a reliable form of contraception,
• Subject describes having a medical history of: a) unstable angina; b) myocardial infarction within the past 3 months; c) coronary angioplasty; or d) an untreated cardiac dysrhythmia;
• Subject currently has cancer \[excluding non-melanoma skin cancer\] not in remission;
• Known allergy to varenicline;

Sponsors & Collaborators

• Mayo Clinic: lead

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Vaping

Interventions

Varenicline

Condition Hierarchy (Ancestors)

Smoking; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Jon Ebbert, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 12 weeks of varenicline

Study Record Dates

• First Submitted: February 14, 2020
• First Posted: March 23, 2020
• Study Start: February 1, 2023
• Primary Completion: February 1, 2023
• Study Completion: February 1, 2023
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share