Nicotine Use DisorderNCT06837220
Implementation of Tobacco Cessation Programming at Community Behavioral Health Sites
A study testing Enhanced Courage to Quit in people with Nicotine Use Disorder and Smoking Cessation, run by University of Chicago at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Nicotine Use Disorder, Smoking Cessation, Smoking Cessation Intervention
- What is being tested?
- Enhanced Courage to Quit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2026to May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 26 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sophie Miller, BS contact
United States1 site, 1 recruiting
- Recruiting
The University of Chicago
Chicago, Illinois, 60637
Emma I. Brett, PhD, 773-834-5341, ebrett@bsd.uchicago.edu
Sophie R Miller, B.S., 7738089807, sophie.miller@bsd.uchicago.edu
About this study
Official title: Enhancing the Implementation of Tobacco Treatment: A Community-responsive Approach
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.
Read the detailed description
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.
- Being tested
- Enhanced Courage to Quit
- Keywords
- smoking, smoking cessation, nicotine, nicotine use disorder, quitting smoking, quitting nicotine, respiratory health, telehealth, virtual, tobacco, tobacco treatment, community, behavioral health, chicago, group therapy, disparities, adults who smoke, cigarettes, tobacco cessation, cessation
- Medical subject headings
- Tobacco Use Disorder, Smoking Cessation, Smoking, Tobacco Use Cessation, Substance-Related Disorders, Behavior, Addictive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Courage to QuitBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilot Intervention | Experimental | The participants in this arm will take part in a pilot test of a community-targeted smoking cessation treatment. This treatment will be evidence-based smoking treatment using cognitive behavioral and motivational strategies implemented according to findings from Phase 1 of this study. The original intervention has four core sessions that will be modified accordingly to fit community needs. Participants will complete pre- and post-session questionnaires regarding their smoking status, quit attempts, use of smoking cessation aids, and other surveys. Receives: Behavioral: Enhanced Courage to Quit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who attend the enhanced intervention as assessed by enrollment and sign-in at each session
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
Measured: 3 months
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
Investigators will consider the intervention design to be feasible if fewer than 40% of enrollees drop out after their first attended session.
Measured: 3 months
A modified version of the Client Satisfaction Questionnaire (CSQ) will assess intervention acceptability.
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).
Measured: End of treatment (e.g., 3 months or fourth session attended, whichever comes first)
Secondary outcomes (4)
Change in number of cigarettes consumed per day
Participant self-report of past week average cigarettes smoked per day
Measured: Through study completion, an average of 3 months
Use of nicotine replacement therapy and FDA-approved cessation medication
Participant self-report of pharmacotherapy will be assessed at each session and end of treatment
Measured: Through study completion, an average of 3 months
Number of quit attempts
The number of times each participant has tried to quit, whether successful or not
Measured: Through study completion, an average of 3 months
Motivation to change smoking behavior via Contemplation Ladder
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.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start20 Jul 2026 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nicotine Use DisorderStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Respiratory Health Association, National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837220
- Sponsor's protocol ID
- IRB24-2154
- Other IDs
- P50MD017349
- Status last verified
- Jul 2026
- First submitted
- 31 Jan 2025
- Last updated
- 7 Jul 2026
- 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Implementation of Tobacco Treatment: A Community-responsive Approach
- ClinicalTrials.gov ID
- NCT06837220
- Acronym / sponsor ID
- IRB24-2154
- Keywords
- smoking, smoking cessation, nicotine, nicotine use disorder, quitting smoking, quitting nicotine, respiratory health, telehealth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Respiratory Health Association, National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 20 Jul 2026 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 20 Feb 2025 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pilot Intervention | Experimental | Behavioral: Enhanced Courage to QuitThe participants in this arm will take part in a pilot test of a community-targeted smoking cessation treatment. This treatment will be evidence-based smoking treatment using cognitive behavioral and motivational strategies implemented according to findings from Phase 1 of this study. The original intervention has four core sessions that will be modified accordingly to fit community needs. Participants will complete pre- and post-session questionnaires regarding their smoking status, quit attempts, use of smoking cessation aids, and other surveys. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
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 |
|---|---|---|
| Enhanced Courage to QuitParticipants 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. | Behavioural | Pilot Intervention |
Primary outcome
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
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.
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).
4 secondary outcomes
Change in number of cigarettes consumed per day
Time frame: Through study completion, an average of 3 months
Use of nicotine replacement therapy and FDA-approved cessation medication
Time frame: Through study completion, an average of 3 months
Number of quit attempts
Time frame: Through study completion, an average of 3 months
Motivation to change smoking behavior via Contemplation Ladder
Time frame: Through study completion, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- 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.
Sophie Miller, BS contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Courage to Quit in people with Nicotine Use Disorder and Smoking Cessation, run by University of Chicago 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 4 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Brett, PhD (773-834-5341, ebrett@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who attend the enhanced intervention as assessed by enrollment and sign-in at each session (time frame: 3 months). The study lists 3 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 7 Jul 2026.