30 Participants Needed

C-Raven for Smoking Addiction

AE
HH
Overseen ByHeidi Hutton, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: Johns Hopkins University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help people quit smoking using a virtual counselor called C-Raven (a digital support tool) and support from a community health worker. The goal is to determine if this approach aids smoking cessation and encourages lung cancer screening. Participants will be divided into two groups: one will receive the intervention immediately, while the other will start after six months. The trial seeks individuals who are 50 or older, currently smoke, and are considering quitting. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What is the safety track record for C-Raven?

Research has shown that virtual programs like C-Raven, which assist people in quitting smoking, are generally safe and easy to use. Similar treatments in past studies were well-tolerated, with users often experiencing only minor side effects. Although specific side effect information for C-Raven isn't provided, its testing in a Phase 4 trial suggests a strong safety record. Phase 4 trials typically focus on treatments already approved for public use, indicating they were found safe in earlier studies.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about C-Raven for smoking addiction because it combines advanced virtual counseling with the support of a community health worker, setting it apart from traditional options like nicotine replacement therapies and medications. This approach emphasizes personalized support and shared decision-making, which can empower participants to make informed choices about their health. Additionally, the integration of lung cancer screening discussions introduces a comprehensive health management strategy, potentially enhancing motivation to quit smoking.

What evidence suggests that the C-Raven intervention is effective for smoking addiction?

Research shows that C-Raven, a virtual program designed to help people quit smoking, uses a computerized avatar counselor to support users. In this trial, participants in one arm will receive the C-Raven program, support from community health workers, and access to nicotine replacement products. Although specific success rates for C-Raven are not yet available, the combination of virtual counseling and community support is believed to facilitate quitting smoking. Studies have indicated that similar programs can improve success rates by offering personalized help and advice. This approach has been tested in other trials, which showed promising results in encouraging people to engage and quit smoking in the short term.23467

Who Is on the Research Team?

AE

Alejandra Ellison-Barnes, MD

Principal Investigator

Johns Hopkins School of Medicine

Are You a Good Fit for This Trial?

This trial is for individuals struggling with nicotine or smoking addiction and are patients at a residency clinic in Baltimore. Participants should be interested in quitting smoking and willing to try virtual counseling, possibly use nicotine replacement products, and undergo lung cancer screening.

Inclusion Criteria

Considering smoking cessation
Planning to remain in local area for at least 6 months
I speak English.
See 2 more

Exclusion Criteria

Contraindication to nicotine replacement therapy
Current engagement in formal smoking cessation program
Major cognitive or psychiatric impairment
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks
1 visit (in-person)

Baseline Assessment

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

1 day
1 visit (in-person)

Treatment

Participants receive computer-delivered counseling and nicotine replacement therapy

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

Follow-up

Participants are monitored for smoking cessation outcomes and intervention acceptability

6 months
Assessments at 1 month, 3 months, and 6 months

What Are the Treatments Tested in This Trial?

Interventions

  • C-Raven
Trial Overview The study tests a computerized avatar-led tobacco cessation program with community health worker support against a waitlist control group. It includes navigation to lung cancer screening services. The effectiveness will be measured over six months through participant engagement and success rates in quitting smoking.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: C-Raven + CHW Smoking Cessation InterventionExperimental Treatment4 Interventions
Group II: No InterventionActive Control1 Intervention

Find a Clinic Near You

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

C-Raven, a Virtual Tobacco Cessation Intervention in the ...The investigators will conduct a pilot randomized controlled trial of an avatar-delivered computerized intervention for tobacco cessation and CHW support to ...
Testing C-Raven, a Virtual Tobacco Cessation - ClinConnectTo inform a future randomized trial of a virtual counselor led computer delivered intervention for tobacco cessation augmented with community health worker ...
Virtual Counseling for Tobacco AddictionThis combination aims to make quitting smoking easier and more successful. Although specific data on C-Raven's success is not yet available, it employs a ...
Testing C-Raven, a Virtual Tobacco Cessation Intervention, in ...... data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be ...
C-Raven, a Virtual Tobacco Cessation Intervention in the ...... data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at ...
C-Raven, a Virtual Tobacco Cessation Intervention in ...Members are chosen based on the scientific skills and knowledge needed to monitor the particular trial. Also called a data safety and monitoring board, or DSMB.
Testing C-Raven, a Virtual Tobacco Cessation Intervention ...It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...
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