Virtual Counseling for Tobacco Addiction

Recruiting at 2 trial locations

Overseen By Alejandra Ellison-Barnes, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Johns Hopkins University

Must not be taking: Tobacco cessation drugs

Disqualifiers: Cognitive, psychiatric, hearing, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

5 Participants Needed

Trial Summary

What is the purpose of this trial?

To inform a future randomized trial of a virtual counselor led computer delivered intervention for tobacco cessation augmented with community health worker (CHW) support and navigation to lung cancer screening in low-income housing units in Baltimore, the investigators propose to collect data on intervention acceptability and feasibility among individuals in public housing as well as feedback on use of shared decision making when referring for low-dose chest CT (LDCT). The investigators will conduct a feasibility pilot study of a virtual counselor plus community health worker intervention. With a sample of participants from public housing units (N=15), 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 and 3 months. At the end of three months, the investigators will conduct follow up interviews with a subset of pilot participants to collect qualitative data on intervention acceptability. Based on this information, the investigators will make iterative improvements to the combined intervention.

Research Team

Jeanne Clark, MD

Principal Investigator

Johns Hopkins School of Medicine

Eligibility Criteria

This trial is for individuals living in low-income housing units in Baltimore who are struggling with tobacco addiction or use disorder. Participants will be involved in a study to test the effectiveness of virtual counseling and support from community health workers, along with lung cancer screening and nicotine replacement products.

Inclusion Criteria

I am 50 years old or older.

Planning to remain in current housing unit for 6 months

Considering smoking cessation

Exclusion Criteria

I am currently using medication to help me stop smoking.

I cannot use nicotine replacement therapy due to health reasons.

Major psychiatric impairment

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (virtual or in-person)

Baseline Assessment

Initial evaluation including demographics, clinical history, and tobacco use history

1 day

1 visit (in-person)

Treatment

Participants receive virtual counseling and nicotine replacement therapy with CHW support

12 weeks

2 visits (in-person), up to 24 remote follow-ups

Follow-up

Participants are monitored for smoking cessation outcomes and intervention acceptability

3 months

Follow-up interviews with a subset of participants

Treatment Details

Interventions

• C-Raven

Trial Overview The trial is testing 'C-Raven', a virtual tobacco cessation program, combined with the help of community health workers. It also includes lung cancer screenings and offers nicotine replacement therapy to aid quitting smoking. The goal is to see how well participants engage with this approach over three months.

Participant Groups

Group I: Smoking Cessation Intervention Experimental Treatment 4 Interventions

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 3 months. Assessments will be conducted at baseline, 1 month, and 3 months.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Maryland Cigarette Restitution Fund

Collaborator

Trials

10

Recruited

900+