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Behavioral Intervention

Virtual Counseling for Tobacco Addiction

Phase 4
Waitlist Available
Led By Alejandra Ellison-Barnes, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 50 or older with current tobacco use of >100 cigarettes smoked in their lifetime
Be older than 18 years old
Must not have
Contraindication to nicotine replacement therapy
Severe hearing impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month, 3 months, 6 months
Awards & highlights

Summary

This trial will test a computerized program to help people quit smoking in low-income housing in Baltimore. Participants will either receive the program with support or be put on a waitlist. The study will look

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since specific side effects are not listed for the interventions like nicotine replacement products or virtual counseling, they may include typical reactions to nicotine substitutes such as headaches, nausea, or skin irritation at patch sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am over 50 and have smoked more than 100 cigarettes in my life.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I cannot use nicotine replacement therapy.
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I have severe hearing loss.
Select...
I am currently using medication to help me stop smoking.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month, 3 months, 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month, 3 months, 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Acceptability and Feasibility as assessed by completion of modules
Acceptability and Feasibility as assessed by number of barriers
Acceptability and Feasibility as assessed by number of sessions with CHW
Secondary study objectives
Number and frequency of interactions with the community health worker
Number of participants that attempt to quit
Number of participants that continue use of nicotine replacement therapy
+6 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: C-Raven + CHW Smoking Cessation InterventionExperimental Treatment4 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 InterventionActive Control1 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.

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Who is running the clinical trial?

WalgreensUNKNOWN
Johns Hopkins UniversityLead Sponsor
2,307 Previous Clinical Trials
14,861,879 Total Patients Enrolled
Maryland Cigarette Restitution FundOTHER_GOV
8 Previous Clinical Trials
827 Total Patients Enrolled
~20 spots leftby Jun 2025
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