Virtual Counseling for Tobacco Addiction

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new virtual counseling program, C-Raven, designed to help people quit smoking, particularly in low-income housing in Baltimore. Participants receive support from a virtual counselor and a community health worker, with options for nicotine replacement therapies and guidance on lung cancer screening. The trial seeks individuals who are 50 or older, currently smoke, and are considering quitting. Feedback will help refine the program for future use. As a Phase 4 trial, this research aims to understand how the already FDA-approved and proven effective treatment benefits more patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are currently using medication to help quit smoking.

What is the safety track record for the C-Raven treatment?

Previous studies have shown promising results for the C-Raven virtual counseling system in helping people quit smoking. Research indicates that this digital program, which uses an avatar as a counselor, has supported long-term smoking cessation. Specifically, one study found a 22.3% increase in the number of people who remained smoke-free.

Regarding safety, the C-Raven system appears well-tolerated, with no reports of serious side effects linked to the virtual counseling. As this trial is in a later stage, the treatment has already passed earlier safety tests. Participants generally find the program easy to use and do not report major negative effects.

Overall, current evidence considers the C-Raven approach safe. It offers a digital method to help people quit smoking, with support from a virtual counselor and a community health worker. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the usual treatments for tobacco addiction, which often involve in-person counseling sessions and medications like varenicline or bupropion, the C-Raven virtual counseling program offers a unique, tech-driven approach. This treatment stands out because it provides participants with access to a virtual counselor, making support more accessible and convenient, especially for those who may struggle to attend in-person sessions. Additionally, it incorporates shared decision-making around lung cancer screening and involves community health workers, offering a more holistic approach to smoking cessation. Researchers are excited about this treatment as it has the potential to increase engagement and success rates by combining technology with personalized support.

What evidence suggests that this virtual counseling intervention is effective for tobacco addiction?

Research has shown that virtual counseling programs, such as C-Raven, which participants in this trial will receive, can help people quit smoking. Studies have found that conversational artificial intelligence (A.I.) holds promise for aiding tobacco cessation. For instance, a digital program called Happy Ending increased long-term quit rates to 22.3% among its users. These programs typically offer online counseling, nicotine replacement options, and support from community health workers. The goal is to provide a comprehensive approach to assist individuals in quitting smoking. ^{1 2 3 4 6}

Who Is on the Research Team?

Jeanne Clark, MD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07220356

C-Raven, a Virtual Tobacco Cessation Intervention in ... The investigators will conduct a pilot randomized controlled trial of an avatar-delivered computerized intervention for tobacco cessation and CHW support to ...

2. ancora.ai ancora.ai/de/details/NCT06545669

C-Raven, a Virtual Tobacco Cessation Intervention in the ... Beschreibung: Participants will receive a virtual counselor intervention for smoking cessation, be offered the opportunity to utilize nicotine replacement ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05145738

Pilot Testing a Computer Delivered Tobacco Cessation ... To this end, the investigators propose a two-arm randomized controlled trial, randomizing up to 90 individuals with tobacco use to the current CRAVEN program ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10623979/

Conversational artificial intelligence interventions to support ... We found limited but promising evidence on the effectiveness of conversational artificial intelligence interventions for tobacco cessation.

5. withpower.com withpower.com/trial/phase-4-tobacco-dependence-7-2024-9b349

Virtual Counseling for Tobacco Addiction A fully automated digital smoking cessation intervention, called Happy Ending, significantly improved long-term abstinence rates among participants (22.3%) ...

6. clinconnect.io clinconnect.io/trials/NCT06289192

Testing C-Raven, a Virtual Tobacco Cessation - ClinConnect To inform a future randomized trial of a virtual counselor led computer delivered intervention for tobacco cessation augmented with community health worker ...