Smoking CessationNCT04717544
Embedding Comprehensive Smoking Cessation Programs Into Community Clinics
A study testing Intervention Arm in people with Smoking Cessation, run by Friends Research Institute, Inc. at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation
- What is being tested?
- Intervention Arm
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 30 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Los Angeles County Department of Health Services and Department of Mental Health Services
Los Angeles, California, 90012
About this study
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.
Read the detailed description
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
- Smoking Cessation
- Being tested
- Intervention Arm
- Keywords
- Smoking cessation, Implementation, Sustainable
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention ArmBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Active comparator | 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. Receives: Behavioral: Intervention Arm |
| Treatment As Usual Arm | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoking Cessation Rate
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.
Measured: Change in carbon monoxide and cotinine levels from Baseline at 3 months
Smoking Cessation Rate
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.
Measured: Change in carbon monoxide and cotinine levels from 3 months at 6 months
Smoking Cessation Rate
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.
Measured: Change in carbon monoxide and cotinine levels from 6 months at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start1 Oct 2019
- Primary completion30 Nov 2022
- Study completion30 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- Friends Research Institute, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- University of California
- Responsible party
- Sponsor
- Investigators
- Theodore C Friedman, M.D., Ph.D., Principal investigator, Charles R. Drew University of Medicine & Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04717544
- Sponsor's protocol ID
- 28CP-0040
- Status last verified
- Aug 2023
- First submitted
- 4 Jan 2021
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Meredith LR, Hurley B, Friedman TC, Lee ML, Rodriguez L, Lopez B, Mtume N, Dixon T, Belani HK, Hsieh S, Ray LA. Implementation of Specialty Tobacco Use Disorder Services in a Community Health Setting: Support for Enhanced Prescription Practices. J Addict Med. 2023 Nov-Dec 01;17(6):677-684. doi: 10.1097/ADM.0000000000001211. Epub 2023 Aug 18.
PubMed 37934530Baskerville WA, Friedman TC, Hurley B, Hsieh S, Dixon T, Mtume N, Lee ML, Rodriguez L, Lopez B, Ray LA. Embedding comprehensive smoking cessation programs into community clinics: study protocol for a cluster-randomized controlled trial. Trials. 2022 Feb 3;23(1):109. doi: 10.1186/s13063-022-06023-3.
PubMed 35115017
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Embedding Comprehensive Smoking Cessation Programs Into Community Clinics
- ClinicalTrials.gov ID
- NCT04717544
- Acronym / sponsor ID
- 28CP-0040
- Conditions
- Smoking Cessation
- Keywords
- Smoking cessation, Implementation, Sustainable
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- Friends Research Institute, Inc.University, hospital or other
- Collaborators
- University of California
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 22 Jan 2021 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Active comparator | Behavioral: Intervention ArmHealthcare 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. |
| Treatment As Usual Arm | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Intervention ArmThe 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. | Behavioural | Intervention Arm |
Primary outcome
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Derived from this study: PubMed 37934530Meredith LR, Hurley B, Friedman TC, Lee ML, Rodriguez L, Lopez B, Mtume N, Dixon T, Belani HK, Hsieh S, Ray LA. Implementation of Specialty Tobacco Use Disorder Services in a Community Health Setting: Support for Enhanced Prescription Practices. J Addict Med. 2023 Nov-Dec 01;17(6):677-684. doi: 10.1097/ADM.0000000000001211. Epub 2023 Aug 18.
- Derived from this study: PubMed 35115017Baskerville WA, Friedman TC, Hurley B, Hsieh S, Dixon T, Mtume N, Lee ML, Rodriguez L, Lopez B, Ray LA. Embedding comprehensive smoking cessation programs into community clinics: study protocol for a cluster-randomized controlled trial. Trials. 2022 Feb 3;23(1):109. doi: 10.1186/s13063-022-06023-3.
- Individual participant dataSharing planned: No
Related trials for Smoking Cessation
Not yet recruiting
New Smoking Cessation Intervention in Primary Care - a Randomized Controlled Trial
Smoking Cessation, Smoking Cessation Counselling
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Not yet recruiting
Contingency Management to Promote Smoking Cessation Study
Smoking Cessation
Not yet recruiting
Flavored Electronic Nicotine Delivery Systems to Lower Smoking and Exposure to Tobacco Toxicants Among Cigarette Smokers Interested in Quitting, REFLECT Trial
Tobacco Cessation, Electronic Nicotine Delivery Systems
Recruiting
Smoking Cessation in Patients With Cancer
Cancer, Tobacco Use
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. This study is not recruiting at the moment.
Theodore C Friedman, M.D., Ph.D. principal investigator
Charles R. Drew University of Medicine & Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention Arm in people with Smoking Cessation, run by Friends Research Institute, Inc. 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: finished, as of the sponsor's last update on 14 Aug 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoking Cessation Rate (time frame: Change in carbon monoxide and cotinine levels from Baseline at 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?
On the ClinicalTrials.gov record for NCT04717544, which also lists 2 linked publications.
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 14 Aug 2023.