C-Raven, a Virtual Tobacco Cessation Intervention in Residency Clinics

NCT07220356 | Recruiting Phase 4 FDA Drug

• 1 other identifier: IRB00450397-2
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

In a residency clinic in Baltimore, the investigators propose to conduct a pilot RCT comparing a) an avatar-delivered computerized intervention (CI) for tobacco cessation augmented with CHW support and navigation to lung cancer screening to b) a waitlist control. With a sample of participants from the residency clinic (N=30), the investigators will collect data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, 1 month, 3 months, and 6 months. The investigators will conduct interviews with a subset of pilot participants to collect qualitative data on intervention acceptability.

Conditions

Tobacco Dependence

Outcome Measures

Primary Outcomes (3)

• Acceptability and Feasibility as assessed by number of participants who complete modules

  1 month

• Acceptability and Feasibility as assessed by number of sessions with CHW

  1 month, 3 months, 6 months

• Number of participants who uptake Low-dose CT Scan

  3 months, 6 months

Secondary Outcomes (2)

• Readiness to Quit as assessed by The Readiness Ruler

  1 month, 3 months, 6 months

• Number of participants who uptake Nicotine Replacement Therapy (NRT)

  3 months, 6 months

Study Arms (2)

C-Raven + CHW Smoking Cessation Intervention

EXPERIMENTAL

Participants will receive a virtual counselor intervention for smoking cessation, be offered the opportunity to utilize nicotine replacement therapies, participate in shared decision-making around lung cancer screening, and be supported by a community health worker. Participants will be followed for a total of 6 months. Assessments will be conducted at baseline, 1 month, 3 months, and 6 months.

Behavioral: C-Raven Virtual Tobacco Cessation Counseling; Drug: Nicotine Replacement Product; Other: Community Health Worker; Other: Lung Cancer Screening

No Intervention

NO INTERVENTION

Participants will not receive any intervention during the first 6 months of the study. The participants will receive the study intervention at the end of 6 months, to ensure access to treatment for all participants.

Interventions

Nicotine Replacement Product DRUG

Participants will be offered up to a 12-week supply of nicotine patches and either nicotine gum or lozenges.

C-Raven + CHW Smoking Cessation Intervention

Community Health Worker OTHER

A community health worker will meet with each participant throughout the study period to teach appropriate NRT usage, discuss barriers/facilitators to NRT use and cessation, conduct shared decision-making about lung cancer screening, and provide health system navigation when needed.

C-Raven + CHW Smoking Cessation Intervention

Lung Cancer Screening OTHER

After participating in shared decision-making, eligible participants will be referred to primary care physician or existing specialist to complete lung cancer screening.

C-Raven + CHW Smoking Cessation Intervention

C-Raven Virtual Tobacco Cessation Counseling BEHAVIORAL

A two-module tobacco cessation intervention that involves interaction with a virtual counselor and includes instruction about addiction and the use of pharmacotherapy for cessation. Each module takes approximately 20 minutes to complete.

C-Raven + CHW Smoking Cessation Intervention

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 or older
• Current tobacco use with \>100 cigarettes smoked in the participant's lifetime
• Considering smoking cessation
• Planning to remain in local area for at least 6 months
• English speaking (intervention currently in English only)

You may not qualify if:

• Contraindication to nicotine replacement therapy
• Current engagement in formal smoking cessation program
• Major cognitive or psychiatric impairment
• Severe hearing impairment
• Investigator discretion

Sponsors & Collaborators

• Johns Hopkins University: lead
• Maryland Cigarette Restitution Fund: collaborator

Study Sites (1)

Johns Hopkins University School of Medicine

Baltimore, Maryland, 21205, United States

RECRUITING

MeSH Terms

Conditions

Tobacco Use Disorder

Interventions

Tobacco Use Cessation Devices; Community Health Workers

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Alejandra Ellison-Barnes, MD

  Johns Hopkins School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandra Ellison-Barnes, MD

CONTACT

410-614-1135; aelliso6@jhmi.edu

Heidi Hutton, PhD

CONTACT

443-287-2874; hhutton@jhmi.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible participants are randomly assigned to intervention or no intervention. Outcomes for those who receive the intervention will be compared to outcomes for those who do not receive the intervention. Those who do not receive the intervention during the initial study period will receive it at the end, to ensure access to treatment for all participants.

Study Record Dates

• First Submitted: October 20, 2025
• First Posted: October 23, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)