Clinical Alternatives for Reducing Harm Using E-cigarettes

NCT07039292 | Recruiting

• 2 other identifiers: Pro001381621R01CA293735-01A1
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

Brief Summary

For patients in cancer care, quitting smoking is critical, but a significant portion of patients in cancer care refuse all components of tobacco treatment, even when offered free of charge. The proposed clinical trial will assess one harm reduction intervention, switching completely from cigarettes to e-cigarettes, among oncology outpatients who smoke and refuse traditional tobacco treatment. This study is a type 1 hybrid effectiveness-implementation trial among oncology outpatients at an NCI-designated cancer center who smoke and refuse all components of tobacco treatment (N=208).

Conditions

Smoking; E-Cig Use; Oncology

Outcome Measures

Primary Outcomes (1)

• Complete switching

  The percentage of participants who are abstinent from combustible cigarettes at the 6-month follow up

  6 months

Secondary Outcomes (1)

• Implementation

  12 weeks

Study Arms (2)

Harm Reduction (E-cigarette switching)

EXPERIMENTAL

Participants will be assigned to receive an e-cigarette and try to switch completely from smoking to using the e-cigarette

Behavioral: Harm Reduction (E-cigarette switching)

Standard of Care

ACTIVE COMPARATOR

Participants will be assigned to receive tobacco treatment referrals and the opportunity to re-enroll in the Tobacco Treatment Program

Behavioral: Standard of Care

Interventions

Harm Reduction (E-cigarette switching) BEHAVIORAL

Participants will be assigned to receive an e-cigarette and try to switch completely from smoking to using the e-cigarette

Harm Reduction (E-cigarette switching)

Standard of Care BEHAVIORAL

Participants will be assigned to receive tobacco treatment referrals and the opportunity to re-enroll in the Tobacco Treatment Program

Standard of Care

Eligibility Criteria

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

You may qualify if:

• age 21+,
• identified as smoking in their medical record and self-report of current smoking within the past 30 days
• refused traditional treatment options through the opt-out HCC Tobacco Treatment Program
• English speaking;

You may not qualify if:

• currently taking part in any TTP or using cessation medication (i.e., taking NRT or other cessation medications, enrolled in the Quitline, or in another study),
• use of e-cigarettes in the past 30 days,
• currently imprisoned,
• pregnant women.

Sponsors & Collaborators

• National Cancer Institute (NCI): collaborator
• National Institutes of Health (NIH): collaborator
• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

MeSH Terms

Conditions

Smoking; Vaping; Neoplasms

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Alana Rojewski

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Tracy Smith

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paris Bedford

CONTACT

854-200-7314; bedfordp@musc.edu

Rachel Christian

CONTACT

chrisrac@musc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor-Faculty

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: August 25, 2025
• Primary Completion (Estimated): May 31, 2029
• Study Completion (Estimated): November 30, 2029
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)