Virtual Counseling for Tobacco Addiction

Overseen By Heidi Hutton, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Johns Hopkins University

Must not be taking: Tobacco cessation treatments

Disqualifiers: Cognitive impairment, Psychiatric impairment, 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: 5

Duration: 12 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people quit smoking by testing a virtual counseling program combined with community health worker support. Participants will receive a computerized intervention called C-Raven (an avatar-delivered computerized intervention for tobacco cessation) and guidance on lung cancer screening. The control group will wait six months before accessing the intervention. This study focuses on individuals living in low-income housing in Baltimore who have smoked more than 100 cigarettes in their lifetime and are considering quitting. Participants must speak English and plan to stay in their current home for nine months. As a Phase 4 trial, this research involves an FDA-approved treatment that has proven effective, aiming to understand how it 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 C-Raven?

Research shows that virtual programs like C-Raven, which help people quit smoking, are generally safe and easy to use. In past studies, treatments similar to C-Raven were tested and showed good results without major safety issues. Participants in these studies had positive experiences with the virtual counselor, who supported them in quitting smoking, along with help from community health workers.

Additionally, the nicotine replacement therapies included in the C-Raven program have been safely used for a long time to help people stop smoking. This combination of virtual counseling and nicotine aids is designed to be both effective and safe.

Since this trial is in a later stage, earlier studies have already checked C-Raven for safety. This stage usually focuses more on effectiveness rather than finding new safety problems. While no treatment is completely without risk, the evidence so far suggests that C-Raven is a safe choice for those wanting to quit smoking. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about the virtual counseling for tobacco addiction because it offers a unique blend of personalized support and technology. Unlike traditional methods like nicotine replacement therapy or face-to-face counseling, this approach combines virtual counseling with community health worker support, making it more accessible and potentially more engaging. Additionally, it incorporates shared decision-making around lung cancer screening, which empowers participants and may enhance their commitment to quitting smoking. This comprehensive, tech-driven method could provide a more flexible and supportive path to cessation, reaching individuals who might not otherwise engage with traditional treatment options.

What evidence suggests that the C-Raven intervention is effective for tobacco cessation?

Studies have shown that virtual counseling can significantly help people quit smoking. Research indicates that a digital program called "Happy Ending" helped 22.3% of participants remain smoke-free long-term. In this trial, one group will receive C-Raven, the treatment under study, which is also a virtual program and includes support from community health workers. This 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 similar approach to other effective digital programs. ^{1 3 6 7 8}

Who Is on the Research Team?

Alejandra Ellison-Barnes, 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 should be interested in quitting smoking and willing to engage with a virtual cessation program and potentially receive lung cancer screening.

Inclusion Criteria

Planning to remain in current housing unit for 9 months

Considering smoking cessation

I am over 50 and have smoked more than 100 cigarettes in my life.

Exclusion Criteria

Investigator discretion

Current engagement in formal smoking cessation program

Major psychiatric impairment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 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 a virtual counselor intervention for smoking cessation and nicotine replacement therapies

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, 3, 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 counseling called C-Raven, supplemented by community health worker support. It compares this approach against waiting for treatment. The effectiveness of the intervention and its implementation will be measured over six months.

How Is the Trial Designed?

Group I: C-Raven + CHW 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 6 months. Assessments will be conducted at baseline, 1 month, 3 months, and 6 months.

Group II: No Intervention Active Control 1 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.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Walgreens

Collaborator

Trials

1

Recruited

30+

Maryland Cigarette Restitution Fund

Collaborator

Trials

10

Recruited

900+

Walgreens

Industry Sponsor

Trials

4

Recruited

3,100+

Published Research Related to This Trial

A qualitative analysis of 742 counseling messages from 270 smokers revealed that the most common theme was 'Support and Strategies for Quitting,' indicating that smokers actively seek guidance and encouragement during their cessation journey.

The study highlights the effectiveness of asynchronous online counseling as a supportive tool for smokers, providing a platform for sharing experiences and strategies throughout the quitting process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring Online Asynchronous Counseling With Tobacco Treatment Specialists in the QUIT-PRIMO and National Dental PBRN HI-QUIT Studies: Who Uses It and What Do They Say? Williams, JH., DeLaughter, K., Volkman, JE., et al.[2019]

In a study involving 725 smokers over a 6-month period, only 33.8% engaged with a trained tobacco treatment specialist (TTS) through asynchronous messaging, indicating low participant engagement.

Despite the feasibility of using asynchronous counseling to provide evidence-based support, there was no significant association between the frequency of TTS communication and smoking cessation outcomes, suggesting that future research should focus on increasing engagement and combining this method with other cessation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Secure Asynchronous Communication Between Smokers and Tobacco Treatment Specialists: Secondary Analysis of a Web-Assisted Tobacco Intervention in the QUIT-PRIMO and National Dental PBRN Networks. Sadasivam, RS., Kamberi, A., DeLaughter, K., et al.[2020]

The pilot study demonstrated that an Internet-based virtual reality program for smoking cessation was acceptable and effective for rural teens, involving seven 1-hour chat sessions over two months with a trained counselor.

Participants showed significant improvements in quitting behaviors, including reduced smoking amounts and increased intentions to quit, along with positive trends in abstinence rates and quit attempts after the intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot test of an Internet virtual world chat room for rural teen smokers. Woodruff, SI., Edwards, CC., Conway, TL., et al.[2019]

A study involving 49 university student smokers found that an avatar-led digital intervention based on Acceptance and Commitment Therapy (ACT) was well-received, with participants reporting high satisfaction and motivation to quit smoking.

Participants particularly enjoyed the unique digital features of the program, such as videos and games, suggesting that future iterations should enhance the realism and interactivity of the avatars to further improve engagement and reduce dropout rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smoking cessation avatar-led Acceptance and Commitment Therapy digital intervention: feasibility and acceptability in young adults. Karekla, M., Savvides, SN.[2021]

Real-time video counselling for smoking cessation was found to be significantly more effective than minimal intervention control (written materials), with 18.9% of participants achieving 7-day point prevalence abstinence compared to 8.9% in the control group, based on a study of 655 rural and remote residents.

While video counselling did not show a significant difference in effectiveness compared to telephone counselling (12.7% abstinence), it suggests that integrating video counselling into smoking cessation services could enhance support for quit attempts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The short-term effectiveness of real-time video counselling on smoking cessation among residents in rural and remote areas: An interim analysis of a randomised trial. Byaruhanga, J., Paul, CL., Wiggers, J., et al.[2022]

The study involved 119 adult daily cigarette smokers and assessed the feasibility of a mobile chat-based intervention combined with nicotine replacement therapy (NRT-S) for smoking cessation, showing that this approach could increase quit attempts and smoking reduction.

At the 6-month follow-up, participants receiving mobile chat support reported higher rates of quitting (10 vs 3) and smoking reduction (20 vs 11) compared to the control group, indicating that the intervention may enhance the effectiveness of NRT in real-world settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile chat-based support plus nicotine replacement therapy sampling to promote smoking cessation for community smokers: A randomized controlled trial. Zhao, SZ., Wu, YS., Chau, SL., et al.[2021]

The web-based smoking cessation tool 'Pare de fumar conosco' significantly increased participants' interest in using pharmacotherapy and group counseling for quitting smoking, with interest levels rising from 22.4% to 82.4% and from 21.2% to 85.9%, respectively.

After 12 weeks, 9.4% of participants reported being smoke-free for at least 7 days, indicating some level of efficacy in promoting smoking cessation among Brazilian patients with chronic conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based decision-making tool for smoking cessation (Pare de fumar conosco) among patients with chronic conditions in Brazil : one-arm feasibility study. Cupertino, AP., Cartujano-Barrera, F., Basile Colugnati, FA., et al.[2023]

In a lab study involving smokers and recent quitters, high realism virtual smoking scenarios increased cravings in recent quitters but decreased cravings in current smokers, highlighting the different effects of realism based on smoking status.

The findings suggest that virtual environments could be a useful tool for Cue-Exposure Therapy (CET) in smoking cessation, but further research is needed to optimize their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

(No) escape from reality? Cigarette craving in virtual smoking environments. de Bruijn, GJ., de Vries, J., Bolman, C., et al.[2022]

This randomized trial will compare the effectiveness of real-time video counselling, telephone counselling, and written materials for smoking cessation among regional and remote residents in New South Wales, Australia, with a focus on achieving smoking abstinence.

The study will assess the primary outcome of 7-day point prevalence abstinence at 13 months post-baseline, potentially demonstrating that video counselling could be a viable and effective alternative to traditional methods for helping people quit smoking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised trial of real-time video counselling for smoking cessation in regional and remote locations: study protocol. Tzelepis, F., Wiggers, J., Paul, CL., et al.[2019]

A fully automated digital smoking cessation intervention, called Happy Ending, significantly improved long-term abstinence rates among participants (22.3%) compared to a control group using a self-help booklet (13.1%) in a study of 396 smokers over 54 weeks.

The treatment group also showed better adherence to nicotine replacement therapy and higher self-efficacy after quitting, suggesting that digital interventions can effectively support behavior change in smoking cessation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Happy ending: a randomized controlled trial of a digital multi-media smoking cessation intervention. Brendryen, H., Kraft, P.[2022]

The study assessed the feasibility and acceptability of an Embodied Conversational Agent (ECA) designed to support smoking cessation among veterans, with 6 participants using the program over 14 days.

All participants found the ECA-Q program satisfactory, and half of them set a quit date by the end of the study, indicating that this virtual coaching approach could be a helpful tool for motivating smokers to quit.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Tablet Based Embodied Conversational Agent to Promote Smoking Cessation among Veterans: A Feasibility Study. Abdullah, AS., Gaehde, S., Bickmore, T.[2020]

The Fact or Fiction Tobacco virtual health tool, launched in 2022, effectively engages users by providing tailored content and referrals to local tobacco cessation resources, reaching 2306 users in its first seven weeks.

User testing indicated that the tool is engaging and user-friendly, with 21.2% of tobacco users intending to quit and 8.8% of those not intending to quit taking action by accessing cessation resources, demonstrating its efficacy in promoting health behavior change.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fact or Fiction? The Development and Evaluation of a Tobacco Virtual Health Tool. Jessiman-Perreault, G., Dunn, R., Erza, A., et al.[2023]

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. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/92/NCT06289192/Prot_SAP_000.pdf

Testing C-Raven, a Virtual Tobacco Cessation Intervention, in ... ... to collect data on the feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be ...

3. 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 ...

4. 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%) ...

5. ctv.veeva.com ctv.veeva.com/study/testing-c-raven-a-virtual-tobacco-cessation-intervention-in-the-community

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

6. 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 ...

7. 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 ...

8. 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.