Clinical trial NCT06837220: Implementation of Tobacco Cessation Programming at Community Behavioral Health Sites
Official title: Enhancing the Implementation of Tobacco Treatment: A Community-responsive Approach
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nicotine Use Disorder
Smoking Cessation
Smoking Cessation Intervention
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
abstinence
substance use
substance abuse
addiction
counseling
health counseling
health communication
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: Respiratory Health Association
name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2025-02-20
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Number of participants who attend the enhanced intervention as assessed by enrollment and sign-in at each session
timeFrame: 3 months
measure: 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
timeFrame: 3 months
measure: A modified version of the Client Satisfaction Questionnaire (CSQ) will assess intervention acceptability.
timeFrame: End of treatement (e.g., 3 months or fourth session attended, whichever comes first)
Secondary outcomes:
measure: Change in number of cigarettes consumed per day
timeFrame: Through study completion, an average of 3 months
measure: Use of nicotine replacement therapy and FDA-approved cessation medication
timeFrame: Through study completion, an average of 3 months
measure: Number of quit attempts
timeFrame: Through study completion, an average of 3 months
measure: Motivation to change smoking behavior via Contemplation Ladder
timeFrame: Through study completion, an average of 3 months
Other outcomes:
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Study officials:
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