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

NCT ID: NCT03502200

Last Updated: 2023-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 350 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-15
• Study Completion Date: 2023-01-31

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.

Detailed Description

There remains a lack of prospective and controlled research on the behavioral, toxicological, and physiological effects of electronic cigarettes (ECs) to help the public health community come to a clear and accurate consensus on their risk-benefit. In order to successfully execute the proposed study, the investigators plan to recruit and enroll recent smoking cessation treatment failures from a state QL, which predominately serves priority populations (e.g., low socioeconomic status, high levels of mental health conditions). The proposed study will randomly assign smokers who were recent QL treatment failures to a) EC (JUUL 5%) or b) QL treatment as usual with combination nicotine replacement therapy control (NRT).

Conditions

Smoking, Cigarette

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

E-cigarette

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

Group Type: EXPERIMENTAL

JUUL

Intervention Type: DEVICE

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

Treatment As Usual

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

Group Type: ACTIVE_COMPARATOR

Treatment As Usual

Intervention Type: OTHER

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

Interventions

JUUL

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

Intervention Type: DEVICE

Treatment As Usual

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• <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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Theodore Wagener

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theodore L Wagener, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State Comprehensive Cancer Center

Locations

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

U01DA045537

Identifier Type: NIH

Identifier Source: secondary_id

View Link

OSU-19133

Identifier Type: -

Identifier Source: org_study_id