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Completed

NCT Number: NCT04717544

Embedding Comprehensive Smoking Cessation Programs Into Community Clinics

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.

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Key information

Conditions

Smoking Cessation Behavior Health Behavior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Los Angeles County Department of Health Services and Department of Mental Health Services

Los Angeles, California, 90012, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Intervention arm

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.

Primary outcomes

  1. Smoking Cessation Rate

    Time frame: Change in carbon monoxide and cotinine levels from Baseline at 3 months

    The primary outcome is to determine if there will be higher rates of smoking cessation in the intervention sites as compared with matched non-intervention sites. In order to measure these rates, study participants will be asked to complete two objective measures collected at 3-month, 6-month and 12-month follow-up. These measures include a carbon monoxide breathalyzer (piCO+smokerlyzer) and urinary rapid dipstick cotinine test (NicCheck). A participant will count as having quit if they reported having abstained from smoking cigarettes/cigars for seven consecutive days and if this report is corroborated by carbon monoxide and cotinine testing.

  2. Smoking Cessation Rate

    Time frame: Change in carbon monoxide and cotinine levels from 3 months at 6 months

    The primary outcome is to determine if there will be higher rates of smoking cessation in the intervention sites as compared with matched non-intervention sites. In order to measure these rates, study participants will be asked to complete two objective measures collected at 3-month, 6-month and 12-month follow-up. These measures include a carbon monoxide breathalyzer (piCO+smokerlyzer) and urinary rapid dipstick cotinine test (NicCheck). A participant will count as having quit if they reported having abstained from smoking cigarettes/cigars for seven consecutive days and if this report is corroborated by carbon monoxide and cotinine testing.

  3. Smoking Cessation Rate

    Time frame: Change in carbon monoxide and cotinine levels from 6 months at 12 months

    The primary outcome is to determine if there will be higher rates of smoking cessation in the intervention sites as compared with matched non-intervention sites. In order to measure these rates, study participants will be asked to complete two objective measures collected at 3-month, 6-month and 12-month follow-up. These measures include a carbon monoxide breathalyzer (piCO+smokerlyzer) and urinary rapid dipstick cotinine test (NicCheck). A participant will count as having quit if they reported having abstained from smoking cigarettes/cigars for seven consecutive days and if this report is corroborated by carbon monoxide and cotinine testing.

Sponsors and collaborators

Lead sponsor

Friends Research Institute, Inc.

Other

Collaborators

  • University of California

Registry information

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2021
Registry last updated
Aug 14, 2023

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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