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Completed

NCT Number: NCT05145738

Pilot Testing a Computer Delivered Tobacco Cessation Intervention in Outpatient Clinical Settings: A Feasibility 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins Tobacco Treatment Clinic at Johns Hopkins Bayview Medical Center

Baltimore, Maryland, 21224, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Actively psychotic or other severe mental health symptoms
  • Any contraindication to NRT use
  • Hearing impaired (unable to listen to audio component of intervention)

Treatment and study plan

C-Raven with avatar

Behavioral

Computer delivered intervention with the investigators' avatar; with linkage to community health worker.

C-Raven without avatar

Behavioral

Computer delivered intervention without the investigators' avatar; with linkage to community health worker.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Readiness to quit smoking as assessed by a visual analog scale

    Time frame: Immediately post intervention

    A visual analog scale of 0-100 with 0 indicating not ready to change and 100 indicating ready to change.

  2. Uptake of pharmacotherapy as assessed by a yes/no response

    Time frame: 3 months

    Any uptake of nicotine replacement therapy or varenicline or wellbutrin. Dichotomous yes/no response will be collected.

  3. Smoking cessation as assessed by 7-day no tobacco use self report

    Time frame: 3 months

    7 day point prevalence abstinence. No tobacco use for 7 days by self report - yes/no.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 6, 2021
Registry last updated
Dec 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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