Recruiting
Phase 3

Tobacco Education

Sponsor:

Georgetown University

Code:

NCT06290869

Conditions

Smoking Cessation

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention

E-Referral to the Tobacco Quitline

Study Details

Brief summary:

Primary Objective To compare two smoking cessation interventions among individuals undergoing lung cancer screening. Primary outcomes are: 3-month self-reported abstinence from cigarettes and 6-month self-reported and bioverified abstinence from cigarettes.

Secondary Objectives 1) To evaluate reach and engagement overall and by subgroup (e.g., race and ethnicity, underinsured, readiness to quit). 2) To conduct an economic analysis to evaluate intervention costs from the health system perspective.

Conditions

Smoking Cessation

Study ID

NCT06290869

Start date

Feb 22, 2024

Status verified date

Feb, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • eligible for a screening or diagnostic scan,
  • USPSTF eligibility criteria (50-80 years old and >20-pack years);
  • currently smoking cigarettes (>1 in the past 30 days);
  • English speaking;
  • able to provide meaningful consent.

Exclusion Criteria:

  • prior lung cancer,
  • hearing impairment,
  • cognitive impairment,
  • household member already enrolled.

Study Design

Enrollment

1188 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MedStar Health System

Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention

active comparator: E-Referral to the Tobacco Quitline

Standard tobacco quitline protocol, including coaching, nicotine replacement, and web-, and text-based resources.

Interventions

Phone-based Tobacco Treatment, Nicotine Replacement, and Stepped Care Intervention

In the MedStar Health System (MHS) arm, we offer 5 phone sessions with a tobacco treatment specialist (TTS) during the first 3 months of treatment plus combination nicotine replacement (patches and lozenges). For those who have not quit at 3 months, 50% will be randomly assigned to stepped care (3 phone sessions with RN/NP + prescription medications as needed) vs. the continued TTS + NRT intervention. Those who have quit at 3 months will be offered 3 relapse prevention phone sessions with the TTS. Thus, all are offered 8 sessions. The TTS will use motivational interviewing to address ambivalence about quitting, education about the risks of continued smoking, encouragement to use and adhere to NRT, and the impact of the screening result (the teachable moment) by framing it as a potential motivator or opportunity to reduce future health risks and to maximize quality of life.

E-Referral to the Tobacco Quitline

In the Quitline E-Referral arm, an e-referral will be generated from the EHR by our staff, will be signed by the LCS ordering provider and sent to the quitline through the closed-looped quitline's success.58-61,123 The quitline is an important comparator, given that it is an evidence-based and low-cost intervention already employed by many LCS sites system and the standard quitline protocol will then occur: 5 proactive contact attempts, up to 5 sessions, and up to 8 weeks of free NRT (depending on supplies). Quitline counselors are highly trained to conduct cessation treatment and extensive research has validated the quitline's success. The quitline is an important comparator, given that it is an evidence-based and low-cost intervention already employed by many LCS sites.

Primary outcome measure

  • Biochemically verified smoking abstinence- MHS vs. QL-E arms [ Time Frame: 6-month assessment ]
  • Biochemically verified smoking abstinence--continued MHS arm vs Stepped Care [ Time Frame: 6-month assessment ]

Central Contacts and Locations

Central contacts

Randi M. Williams, PhD

rmw27@georgetown.edu

Locations

Georgetown University Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20007

Contacts

More Information

Sponsor

Georgetown University

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Keywords

  • high risk for lung cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Georgetown University on 2026-02-17.