Tobacco SmokingNCT05145738
Pilot Testing a Computer Delivered Tobacco Cessation Intervention in Outpatient Clinical Settings: A Feasibility Study
A study testing C-Raven with avatar and C-Raven without avatar in people with Tobacco Smoking, run by Johns Hopkins University at 1 site in United States.
Trial summary
The investigators have developed a hybrid computer- and person-delivered intervention, called "C-Raven" for smoking cessation that is tailored to people with tobacco use in Baltimore City. The computer delivered component consists of two ~20 minute sessions on an iPad guided by Edna Poe, an interactive avatar. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Smoking
- What is being tested?
- C-Raven with avatar and C-Raven without avatar
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Dec 2021to 15 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age receiving care in one of the two specified clinics
- Current daily smoker and has smoked >100 cigarettes in their lifetime
- English speaking
- Cognitively able to understand proposed research design
Who cannot join
- Actively psychotic or other severe mental health symptoms
- Any contraindication to NRT use
- Hearing impaired (unable to listen to audio component of intervention)
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Tobacco Treatment Clinic at Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21224
About this study
The investigators have developed a hybrid computer- and person-delivered intervention, called "C-Raven" for smoking cessation that is tailored to people with tobacco use in Baltimore City. The computer delivered component consists of two ~20 minute sessions on an iPad guided by Edna Poe, an interactive avatar. These sessions are followed by elective in vivo initiation of nicotine replacement therapy (NRT). Community health workers (CHWs) trained in smoking cessation and motivational interviewing provide 6 weeks of supportive follow up counseling. The investigators propose a pilot of the intervention package in the Tobacco Treatment and Lung Cancer Screening Clinic (TTLCSC) at Johns Hopkins Hospital, and the Johns Hopkins Broadway Center for Addiction, assessing feasibility and acceptability of using this tool in these clinical settings. In addition, the investigators will compare whether the use of a virtual counselor is associated with greater satisfaction and engagement with the program.
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 which includes a virtual counselor, to CRAVEN without a virtual counselor. Primary outcomes include intervention feasibility and acceptability. The investigators will secondarily examine uptake and maintenance of pharmacotherapy for tobacco cessation, readiness to quit smoking, and tobacco cessation (7 day abstinence) at 6 months, patient satisfaction by intervention arm and CHW engagement by intervention arm.
- Conditions
- Tobacco Smoking
- Being tested
- C-Raven with avatar, C-Raven without avatar
- Medical subject headings
- Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Raven with avatarBehavioural
Computer delivered intervention with the investigators' avatar; with linkage to community health worker.
C-Raven without avatarBehavioural
Computer delivered intervention without the investigators' avatar; with linkage to community health worker.
| Study group | Role | What they receive |
|---|---|---|
| C-Raven + Avatar | Experimental | Computer delivered intervention with Avatar as virtual counselor plus linkage to community health worker Receives: Behavioral: C-Raven with avatar |
| C-Raven | Active comparator | Computer-delivered intervention without virtual counselor, with linkage to community health worker Receives: Behavioral: C-Raven without avatar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of persons agreeing to participate among those referred
Feasibility will be assessed with percent of persons agreeing to participate among those referred.
Measured: 3 months
Percent of contacts made with community health worker
Implementation will be assessed with percent of contacts made with community health worker.
Measured: 3 months
Secondary outcomes (3)
Readiness to quit smoking as assessed by a visual analog scale
A visual analog scale of 0-100 with 0 indicating not ready to change and 100 indicating ready to change.
Measured: Immediately post intervention
Uptake of pharmacotherapy as assessed by a yes/no response
Any uptake of nicotine replacement therapy or varenicline or wellbutrin. Dichotomous yes/no response will be collected.
Measured: 3 months
Smoking cessation as assessed by 7-day no tobacco use self report
7 day point prevalence abstinence. No tobacco use for 7 days by self report - yes/no.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start23 Dec 2021
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco SmokingStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geetanjali Chander, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145738
- Sponsor's protocol ID
- IRB00300496
- Status last verified
- Nov 2025
- First submitted
- 23 Nov 2021
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing a Computer Delivered Tobacco Cessation Intervention in Outpatient Clinical Settings: A Feasibility Study
- ClinicalTrials.gov ID
- NCT05145738
- Acronym / sponsor ID
- IRB00300496
- Conditions
- Tobacco Smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 23 Dec 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 6 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators have developed a hybrid computer- and person-delivered intervention, called "C-Raven" for smoking cessation that is tailored to people with tobacco use in Baltimore City. The computer delivered component consists of two ~20 minute sessions on an iPad guided by Edna Poe, an interactive avatar. These sessions are followed by elective in vivo initiation of nicotine replacement therapy (NRT). Community health workers (CHWs) trained in smoking cessation and motivational interviewing provide 6 weeks of supportive follow up counseling. The investigators propose a pilot of the intervention package in the Tobacco Treatment and Lung Cancer Screening Clinic (TTLCSC) at Johns Hopkins Hospital, and the Johns Hopkins Broadway Center for Addiction, assessing feasibility and acceptability of using this tool in these clinical settings. In addition, the investigators will compare whether the use of a virtual counselor is associated with greater satisfaction and engagement with the program.
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 which includes a virtual counselor, to CRAVEN without a virtual counselor. Primary outcomes include intervention feasibility and acceptability. The investigators will secondarily examine uptake and maintenance of pharmacotherapy for tobacco cessation, readiness to quit smoking, and tobacco cessation (7 day abstinence) at 6 months, patient satisfaction by intervention arm and CHW engagement by intervention arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| C-Raven + Avatar | Experimental | Behavioral: C-Raven with avatarComputer delivered intervention with Avatar as virtual counselor plus linkage to community health worker |
| C-Raven | Active comparator | Behavioral: C-Raven without avatarComputer-delivered intervention without virtual counselor, with linkage to community health worker |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults ≥18 years of age receiving care in one of the two specified clinics
- Current daily smoker and has smoked >100 cigarettes in their lifetime
- English speaking
- Cognitively able to understand proposed research design
Key exclusion criteria (3 listed)
- Actively psychotic or other severe mental health symptoms
- Any contraindication to NRT use
- Hearing impaired (unable to listen to audio component of intervention)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| C-Raven with avatarComputer delivered intervention with the investigators' avatar; with linkage to community health worker. | Behavioural | C-Raven + Avatar |
| C-Raven without avatarComputer delivered intervention without the investigators' avatar; with linkage to community health worker. | Behavioural | C-Raven |
Primary outcome
Percent of persons agreeing to participate among those referred
Time frame: 3 months
Feasibility will be assessed with percent of persons agreeing to participate among those referred.
Percent of contacts made with community health worker
Time frame: 3 months
Implementation will be assessed with percent of contacts made with community health worker.
3 secondary outcomes
Readiness to quit smoking as assessed by a visual analog scale
Time frame: Immediately post intervention
Uptake of pharmacotherapy as assessed by a yes/no response
Time frame: 3 months
Smoking cessation as assessed by 7-day no tobacco use self report
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geetanjali Chander principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing C-Raven with avatar and C-Raven without avatar in people with Tobacco Smoking, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of persons agreeing to participate among those referred (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2025.