Switching to a Vaping Device: Evaluating Risk Reduction Among Quitline Treatment Failures

NCT03502200 | Completed Results DMC FDA Device

• 2 other identifiers: OSU-19133U01DA045537
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

Brief Summary

The overall aim of the study is to evaluate the provision of e-cigarette (EC) versus NRT on smoking behavior, product use patterns and continued use, and iCO, a biomarker of toxicant exposure, among a sample of recent QL treatment failures. We will randomly assign N=372 smokers (targeted accrual) to EC (n=186) or QL treatment as usual with combination nicotine replacement therapy (NRT; n=186). All participants will receive three calls from QL coaches and EC and NRT will be provided at no cost for 8 weeks. The final follow-up will occur 12-weeks post baseline.

Conditions

Smoking, Cigarette

Keywords

e-cigarettes; harm reduction; smoking behavior

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants With Self-Reported 7-day Point Prevalence Abstinence From Cigarettes

  Self-Reported 7-day Point Prevalence Abstinence from Cigarettes to assess complete product switching/substitution.

  Daily for 12 weeks

• Proportion of Participants With iCO (Portable Carbon Monoxide Monitor) Verified Abstinence

  Intent to treat biochemically verified abstinence rates - participants reporting both 7-day point prevalence abstinence and an iCO reading less than or equal to 8. A portable exhaled carbon monoxide detector confirms daily smoking status. Used to evaluate changes iCO, a biomarker of tobacco constituent exposure and other health effects.

  12 weeks

Secondary Outcomes (12)

• Sociodemographic Questionnaire - Age

  Baseline

• Sociodemographic Questionnaire - Sex

  Baseline

• Sociodemographic Questionnaire - Marital Status

  Baseline

• Sociodemographic Questionnaire - Ethnicity

  Baseline

• Sociodemographic Questionnaire - Employment Status

  Baseline

Other Outcomes (6)

• Tobacco Use History Questionnaire - Years of Smoking

  Week 1 (baseline)

• Tobacco Use History Questionnaire - Cigarettes Per Day

  Week 1 (baseline)

• Tobacco Use History Questionnaire - 24-hour Quit Attempts

  Week 1 (baseline)

Study Arms (2)

E-cigarette

EXPERIMENTAL

5% nicotine JUUL e-cigarette (Tobacco or Menthol flavor). Will also receive counseling.

Device: JUUL

Treatment As Usual

ACTIVE COMPARATOR

Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard assessments. Will also receive counseling.

Other: Treatment As Usual

Interventions

JUUL DEVICE

Participants randomized to the JUUL group will receive either tobacco or menthol flavored JUUL with 5% nicotine. Will also receive counseling.

E-cigarette

Treatment As Usual OTHER

Nicotine Replacement Therapy consisting of nicotine patches and lozenge along with standard quitline counseling.

Treatment As Usual

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• smoke ≥5 cigarettes per day for the past year
• read, write, and speak in English
• report at least minimal interest in switching to an alternative product (\> "not at all" on a Likert scale)
• participation in the Oklahoma Tobacco Helpline or South Carolina Tobacco Helpline within the last 4-7 months.

You may not qualify if:

• \<21 years old
• report NRT use or making a quit attempt within the last 7 days
• current daily use of an e-cigarette over last month.
• unstable or significant medical condition such as respiratory, kidney, or liver disease
• unstable or significant psychiatric conditions (past and stable conditions will be allowed)
• history of cardiac event or distress within the past 6 months
• currently pregnant, planning to become pregnant, or breastfeeding.
• currently enrolled in a contradictory study.
• cohabitates with a currently enrolled participant in the REACH study
• reaction to using patch medication or adhesive tape
• known allergy to propylene glycol or vegetable glycerin

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Conditions

Cigarette Smoking; Vaping; Harm Reduction; Smoking

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Tobacco Smoking; Behavior; Tobacco Use

Results Point of Contact

• Title: Dr. Theodore L. Wagener
• Organization: OhioSUCCC

Theodore.Wagener@osumc.edu

614-366-4265

Study Officials

• Theodore L Wagener, PhD

  Ohio State Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study is a comparative randomized study.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be assigned to one of two conditions randomly.

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: April 18, 2018
• Study Start: October 15, 2020
• Primary Completion: January 31, 2023
• Study Completion: January 31, 2023
• Last Updated: July 21, 2023
• Results First Posted: July 21, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)