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NCT Number: NCT06837220

Implementation of Tobacco Cessation Programming at Community Behavioral Health Sites

The goal of this study is to: partner with Respiratory Health Association and determine barriers and unmet smoking cessation treatment needs from leaders in behavioral health organizations, treatment programs and adults who smoke (AWS) in Chicago. This will be accomplished by establishing a community advisory board (CAB) and pilot testing a community-informed smoking cessation treatment within a community behavioral health organization to determine its feasibility after addressing implementation issues.

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Key information

Conditions

Nicotine Use Disorder Behavior Behavior, Addictive Chemically-Induced Disorders Compulsive Behavior Health Behavior Impulsive Behavior Mental Disorders Smoking Smoking Cessation Smoking Cessation Intervention Substance-Related Disorders Tobacco Use Cessation Tobacco Use Disorder

Age range

18 year–26 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The purpose of the proposed study is to determine barriers and unmet smoking cessation treatment needs from leaders in behavioral health organizations, behavioral health treatment providers, and community members in Chicago and pilot test a community-informed, targeted rolling smoking cessation treatment within a community organization. The research team and the Respiratory Health Association (RHA) will work together to identify community sites that could derive possible benefit from adopting and implementing the targeted treatment.

Aim 1: Develop a Community Advisory Board (CAB) comprised of providers, community members, and organization leadership.

Aim 2: Use a mixed-methods approach to understand barriers, facilitators, and unmet treatment needs regarding smoking cessation treatment within the community.

Aim 3: Pilot test the targeted smoking cessation treatment across a 3-month period at one community site through partnership with Respiratory Health Association.

Hypothesis: The targeted intervention will demonstrate feasibility and acceptability.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Identify as someone who currently smokes combustible cigarettes (at least 1 cigarette per day) on each day for the past month
  • Report interest in quitting cigarettes (at least 6/10 scale in interest of quitting)
  • Age 18 or older, ability to understand the English language, willing and able to provide informed consent
  • Stable residence and contact information throughout the follow up period

Exclusion criteria

  • Non-daily or intermittent cigarette use
  • No interest in quitting smoking
  • Unstable residence/not staying in Chicago for duration of study period
  • Current untreated severe substance use disorder (with the exception of tobacco use) or past-year serious untreated psychiatric illness (e.g. schizophrenia, bipolar disorder, obsessive compulsive disorder, unspecified psychosis, past-year suicide attempt)

Treatment and study plan

Enhanced Courage to Quit

Behavioral

Participants will engage in a version of the smoking cessation treatment "Courage to Quit" that has been optimized for implementation in community behavioral health clinics. The group will run over a period of 3 months, where participants will learn behavioral and cognitive skills for smoking cessation and/or reduction. Special attention will be given to the unique needs of the community, such as technology options or more flexible treatment models. The goal of this intervention is to prove that it is feasible to implement, and can create enhanced engagement and smoking outcomes for adults who smoke (AWS) and have fewer socioeconomic resources.

Primary outcomes

  1. Number of participants who attend the enhanced intervention as assessed by enrollment and sign-in at each session

    Time frame: 3 months

    Investigators will consider the initial pilot period of the enhanced intervention successful if the team enrolls (attend one session) and retains (attend four or more sessions) at least three participants in the pilot treatment across three months

  2. Feasibility will be assessed by calculating the portion of people who enroll (attend at least on session) and complete 4+ sessions versus those who drop out before finishing 4 sessions as assessed by session sign-in

    Time frame: 3 months

    Investigators will consider the intervention design to be feasible if fewer than 40% of enrollees drop out after their first attended session.

  3. A modified version of the Client Satisfaction Questionnaire (CSQ) will assess intervention acceptability.

    Time frame: End of treatment (e.g., 3 months or fourth session attended, whichever comes first)

    This measure is a 10-point Likert scale (0=not at all, 10=very much) that assesses items such as intervention quality, effectiveness, and intrusiveness. For acceptability, the study team predicts at least 75% of participants will rate the intervention as acceptable via post-treatment survey (CSQ).

Secondary outcomes

  1. Change in number of cigarettes consumed per day

    Time frame: Through study completion, an average of 3 months

    Participant self-report of past week average cigarettes smoked per day

  2. Use of nicotine replacement therapy and FDA-approved cessation medication

    Time frame: Through study completion, an average of 3 months

    Participant self-report of pharmacotherapy will be assessed at each session and end of treatment

  3. Number of quit attempts

    Time frame: Through study completion, an average of 3 months

    The number of times each participant has tried to quit, whether successful or not

  4. Motivation to change smoking behavior via Contemplation Ladder

    Time frame: Through study completion, an average of 3 months

    Participants' interest in quitting will be assessed on a 10-point quit interest scale (e.g., The Contemplation Ladder). Scores range from 0-10 with higher scores indicating greater motivation to change.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Brett, PhD

CONTACT

[email protected]

773-834-5341

Sophie Miller, BS

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Institute on Minority Health and Health Disparities (NIMHD)
  • Respiratory Health Association

Registry information

Official study title

Enhancing the Implementation of Tobacco Treatment: A Community-responsive Approach

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Feb 20, 2025
Registry last updated
Jul 7, 2026

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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