Embedding Comprehensive Smoking Cessation Programs Into Community Clinics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

406 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2022-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The study will evaluate a sustainable tobacco screening, treatment intervention, and cessation program implemented within both Los Angeles County (LAC)-Department of Health Services (LACDHS)-operated outpatient primary care clinics and in LAC-Department of Mental Health (LACDMH)-operated community mental health clinics. This is a three year implementation study funded by the University of California Office of the President Tobacco Related Disease Research Program (TRDRP). This project will support the implementation of smoking cessation services delivered in LACDHS and LACDMH clinics and will evaluate the effectiveness and feasibility of these services.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Promoting Evidenced-Based Tobacco Smoking Cessation Treatment in Community Mental Health Clinics

NCT04796961

Tobacco Smoking

COMPLETED NA

Small Financial Incentives to Promote Smoking Cessation

NCT02737566

Smoking Cessation

COMPLETED NA

Integrating Financial Coaching and Smoking Cessation Coaching

NCT05154669

Smoking

RECRUITING PHASE3

Mobile-based Peer Mentoring for Smoking Cessation

NCT03048786

Smoking Cessation Tobacco Use

COMPLETED NA

Proactive Outreach for Smoking Treatment

NCT04988477

Smoking, Tobacco Mental Illness

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The research hypothesis is that training LACDHS and LACDMH staff and clinicians to screen for and treat tobacco use disorder will improve rates of remission from tobacco use disorder in the clients served by each system.

This is a cluster randomized comparative effectiveness trial that compares intervention clinics (offer smoking cessation group counseling and medication management) integrated into primary care and community mental health clinics with treatment as usual (offering information about the California Smoker's Helpline and informal provider counseling). The specific aim is to randomize 17 clinics (11 at LACDHS and 6 at LACDMH), with a 5:1 ratio in the assignment of clinical sites assigned to offer smoking cessation services as compared to the treatment as usual (TAU).

In addition to providing support for the implementation of the smoking cessation services, the study will enroll 1,200 clients with tobacco use disorder from all 17 participating clinics for an outcome study; 1000 people from clinical sites where smoking cessation treatment are being offered and 200 people with tobacco use disorder from the TAU clinical sites. The primary study outcome is to determine if there will be higher rates of smoking cessation in the implementation sites as compared with TAU sites that do not offer smoking cessation treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Smoking Cessation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention Arm

Healthcare providers from clinics participating in the intervention refer existing clients to study coordinators for smoking cessation services, wherein the coordinators link clients to the smoking cessation services, which include: 1) a weekly cognitive-behavioral therapy smoking cessation (CBT) counseling group; and 2) smoking cessation medication, which include varenicline (Chantix), bupropion (Zyban) and nicotine patches, gum, and lozenges. Clients interested in these medications will meet with the prescribing clinician to help choose the best prescription option.

In addition to linking clients to the smoking cessation services, coordinators will invite clients to participate in the outcome study.

Existing clients can sign-up for these services and/or the outcome study directly with the study coordinators and do not require a healthcare provider referral.

Group Type ACTIVE_COMPARATOR

Intervention Arm

Intervention Type BEHAVIORAL

The smoking cessation intervention will include 1) a six-week, 60-75 minute weekly cognitive-behavioral therapy (CBT) smoking cessation counseling group; and 2) smoking cessation medication include varenicline (Chantix), bupropion (Zyban) and nicotine replacement therapy (NRT). Dispensing these medications will include a 15-minute medication management visit with a prescribing clinician. Clients will choose their own preferred treatment. The standard prescription for NRT will include a transdermal patch at a dose that approximates for current average mg of nicotine intake and nicotine gums or lozenges (in either 2 mg or 4 mg strengths). Prescription for varenicline will be 0.5 mg once daily for three days, then 0.5 mg twice daily for the next four days, then 1 mg twice daily thereafter. Absent any contraindications to the drugs listed above, bupropion (Zyban) 150mg will be offered and prescribed once daily for one week, following by bupropion 300 mg once daily thereafter.

Treatment As Usual Arm

Existing clients can be referred to the outcome study by their healthcare providers from clinics designated as TAU or they can sign-up directly with the study coordinators.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intervention Arm

The smoking cessation intervention will include 1) a six-week, 60-75 minute weekly cognitive-behavioral therapy (CBT) smoking cessation counseling group; and 2) smoking cessation medication include varenicline (Chantix), bupropion (Zyban) and nicotine replacement therapy (NRT). Dispensing these medications will include a 15-minute medication management visit with a prescribing clinician. Clients will choose their own preferred treatment. The standard prescription for NRT will include a transdermal patch at a dose that approximates for current average mg of nicotine intake and nicotine gums or lozenges (in either 2 mg or 4 mg strengths). Prescription for varenicline will be 0.5 mg once daily for three days, then 0.5 mg twice daily for the next four days, then 1 mg twice daily thereafter. Absent any contraindications to the drugs listed above, bupropion (Zyban) 150mg will be offered and prescribed once daily for one week, following by bupropion 300 mg once daily thereafter.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years old or older
* smoke 3 or more cigarettes or cigars per day
* have thought about smoking cessation
* be enrolled in care at either LACDHS and/or LACDMH.

Exclusion Criteria

* under 18 years
* smoke less than 3 cigarettes or cigars per day
* not interested in smoking cessation
* not enrolled in care at either LACDHS and/or LACDMH.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes