Smoking CessationPhase 4NCT02511236
Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention
A Phase 4 study testing Group Cognitive Behavioral Therapy, General Health Education and Transdermal Nicotine Patch in people with Smoking Cessation, run by University of Miami at 2 sites in United States.
Trial summary
The purpose of this study is to test the effects of a group smoking cessation program. The study will also examine individual differences in response to the intervention program. 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?
- Group Cognitive Behavioral Therapy, General Health Education and Transdermal Nicotine Patch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 356 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2015to 23 Oct 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Self-identify as African American/Black, Hispanic (any race), or White non-Hispanic
- Smoke at least 5 cigarettes/day or carbon monoxide (CO) reading of at least 8 ppm
- be over age 18
- speak/read English and/or Spanish
Who cannot join
- Contraindications for transdermal nicotine patch therapy (TNP)
- Cognitive or mental health impairment that inhibits group treatment
- Currently being treated for smoking cessation, alcoholism, or illicit drug use
- Unable to attend sessions
- Indications that participant is not appropriate for the study (e.g., aggressive, intoxicated, disruptive, visibly ill)
- Does not self-identify as African American, Hispanic, or White (non-Hispanic)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Miami
Coral Gables, Florida, 33124
H Lee Moffitt Cancer Center
Tampa, Florida, 33612
About this study
The purpose of this study is to test the effects of a group smoking cessation program. The study will also examine individual differences in response to the intervention program.
- Conditions
- Smoking Cessation
- Being tested
- Group Cognitive Behavioral Therapy, General Health Education, Transdermal Nicotine Patch
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Cognitive Behavioral TherapyBehavioural
The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include a functional analysis of smoking patterns, environmental cues, and motivation for change, and cover nicotine addiction and withdrawal, health consequences, benefits of cessation, stress management, negative affect, alcohol use, triggers, coping responses, cognitive restructuring, social support, decision making, weight control, and physical activity.
General Health EducationBehavioural
The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include didactic information on tobacco-associated morbidities, such as heart disease, diabetes, and hypertension. Content may include Power Point-delivered lectures on the prevalence, etiology, basic pathology, symptom patterns, and treatment of the conditions, and discussion questions designed to facilitate learning and interest. Smoking cessation specific topics will not be addressed, and coping skills will not be provided. Participants will be allowed to share feelings regarding smoking (if they mention them) and general questions will be answered, although no specific behavioral quitting advice will be provided (i.e., they will be encouraged to adhere to the TNP protocol).
Transdermal Nicotine PatchDrug
Also called Nicotine Patch
Participants will be prescribed up to 8 weeks of transdermal nicotine patch therapy, including 21 mg for 4 weeks, 14 mg for 2 weeks, and 7 mg for 2 weeks. Dosages will be adjusted per manufacturer recommendations.
| Study group | Role | What they receive |
|---|---|---|
| Group Cognitive Behavioral Therapy | Experimental | Participants may receive 8 group cognitive behavioral therapy (CBT) sessions and eight weeks of transdermal nicotine patches (TNP) [21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)]. Receives: Behavioral: Group Cognitive Behavioral Therapy; Drug: Transdermal Nicotine Patch |
| General Health Education | Active comparator | Participants may receive group general health education (GHE) sessions and eight weeks of transdermal nicotine patches (TNP) [21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)]. Receives: Behavioral: General Health Education; Drug: Transdermal Nicotine Patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Reporting 7 Day Point Prevalence Abstinence
Reported will be the number of participants reporting 7 day point prevalence of smoking abstinence
Measured: 12-months
Change in Perceived Stress Scores
The Perceived Stress Scale (PSS) is a 10-item questionnaire with scores ranging from 0-40 with higher scores indicated greater stress.
Measured: Baseline, 4 weeks
Change in Depressive Symptoms Scores
Depressive scores based on Center for Epidemiologic Studies Depression Scale (CESD). CESD has a total score ranging from 0-60 with a higher score indicating greater depressive symptoms.
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2015 (estimated)
- Study startAug 2015
- Primary completion23 Oct 2019
- Study completion23 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 356 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- H. Lee Moffitt Cancer Center and Research Institute, James and Esther King Biomedical Research Program
- Responsible party
- Principal investigator, David Lee, University of Miami
- Investigators
- David Lee, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02511236
- Sponsor's protocol ID
- 20150356
- Status last verified
- Jun 2021
- First submitted
- 24 Jul 2015
- Last updated
- 24 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Webb Hooper M, Lee DJ, Simmons VN, Brandon KO, Antoni MH, Asfar T, Koru-Sengul T, Brandon TH. Cognitive behavioral therapy versus general health education for smoking cessation: A randomized controlled trial among diverse treatment seekers. Psychol Addict Behav. 2024 Feb;38(1):124-133. doi: 10.1037/adb0000928. Epub 2023 May 4.
PubMed 37141036Webb Hooper M, Lee DJ, Simmons VN, Brandon KO, Antoni MH, Unrod M, Asfar T, Correa JB, Koru-Sengul T, Brandon TH. Reducing racial/ethnic tobacco cessation disparities via cognitive behavioral therapy: Design of a dualsite randomized controlled trial. Contemp Clin Trials. 2018 May;68:127-132. doi: 10.1016/j.cct.2018.03.017. Epub 2018 Apr 1.
PubMed 29617633
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Racial/Ethnic Tobacco Health Disparities Via Group Intervention
- ClinicalTrials.gov ID
- NCT02511236
- Acronym / sponsor ID
- 20150356
- Conditions
- Smoking Cessation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 356 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- H. Lee Moffitt Cancer Center and Research Institute, James and Esther King Biomedical Research Program
- Study start
- Aug 2015
- Primary completion
- 23 Oct 2019 (actual)
- Study completion
- 23 Oct 2019 (actual)
- First posted
- 29 Jul 2015 (estimated)
- Results
- Posted 24 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the effects of a group smoking cessation program. The study will also examine individual differences in response to the intervention program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Cognitive Behavioral Therapy | Experimental | Behavioral: Group Cognitive Behavioral Therapy, Drug: Transdermal Nicotine PatchParticipants may receive 8 group cognitive behavioral therapy (CBT) sessions and eight weeks of transdermal nicotine patches (TNP) [21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)]. |
| General Health Education | Active comparator | Behavioral: General Health Education, Drug: Transdermal Nicotine PatchParticipants may receive group general health education (GHE) sessions and eight weeks of transdermal nicotine patches (TNP) [21mg (4 weeks), 14mg (2 weeks), and 7mg (2 weeks)]. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Self-identify as African American/Black, Hispanic (any race), or White non-Hispanic
- Smoke at least 5 cigarettes/day or carbon monoxide (CO) reading of at least 8 ppm
- be over age 18
- speak/read English and/or Spanish
Key exclusion criteria (6 listed)
- Contraindications for transdermal nicotine patch therapy (TNP)
- Cognitive or mental health impairment that inhibits group treatment
- Currently being treated for smoking cessation, alcoholism, or illicit drug use
- Unable to attend sessions
- Indications that participant is not appropriate for the study (e.g., aggressive, intoxicated, disruptive, visibly ill)
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 |
|---|---|---|
| Group Cognitive Behavioral TherapyThe four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include a functional analysis of smoking patterns, environmental cues, and motivation for change, and cover nicotine addiction and withdrawal, health consequences, benefits of cessation, stress management, negative affect, alcohol use, triggers, coping responses, cognitive restructuring, social support, decision making, weight control, and physical activity. | Behavioural | Group Cognitive Behavioral Therapy |
| General Health EducationThe four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include didactic information on tobacco-associated morbidities, such as heart disease, diabetes, and hypertension. Content may include Power Point-delivered lectures on the prevalence, etiology, basic pathology, symptom patterns, and treatment of the conditions, and discussion questions designed to facilitate learning and interest. Smoking cessation specific topics will not be addressed, and coping skills will not be provided. Participants will be allowed to share feelings regarding smoking (if they mention them) and general questions will be answered, although no specific behavioral quitting advice will be provided (i.e., they will be encouraged to adhere to the TNP protocol). | Behavioural | General Health Education |
| Transdermal Nicotine PatchAlso: Nicotine PatchParticipants will be prescribed up to 8 weeks of transdermal nicotine patch therapy, including 21 mg for 4 weeks, 14 mg for 2 weeks, and 7 mg for 2 weeks. Dosages will be adjusted per manufacturer recommendations. | Drug | General Health Education, Group Cognitive Behavioral Therapy |
Primary outcome
The Number of Participants Reporting 7 Day Point Prevalence Abstinence
Time frame: 12-months
Reported will be the number of participants reporting 7 day point prevalence of smoking abstinence
Change in Perceived Stress Scores
Time frame: Baseline, 4 weeks
The Perceived Stress Scale (PSS) is a 10-item questionnaire with scores ranging from 0-40 with higher scores indicated greater stress.
Change in Depressive Symptoms Scores
Time frame: Baseline, 4 weeks
Depressive scores based on Center for Epidemiologic Studies Depression Scale (CESD). CESD has a total score ranging from 0-60 with a higher score indicating greater depressive symptoms.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37141036Webb Hooper M, Lee DJ, Simmons VN, Brandon KO, Antoni MH, Asfar T, Koru-Sengul T, Brandon TH. Cognitive behavioral therapy versus general health education for smoking cessation: A randomized controlled trial among diverse treatment seekers. Psychol Addict Behav. 2024 Feb;38(1):124-133. doi: 10.1037/adb0000928. Epub 2023 May 4.
- Derived from this study: PubMed 29617633Webb Hooper M, Lee DJ, Simmons VN, Brandon KO, Antoni MH, Unrod M, Asfar T, Correa JB, Koru-Sengul T, Brandon TH. Reducing racial/ethnic tobacco cessation disparities via cognitive behavioral therapy: Design of a dualsite randomized controlled trial. Contemp Clin Trials. 2018 May;68:127-132. doi: 10.1016/j.cct.2018.03.017. Epub 2018 Apr 1.
- 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. This study is not recruiting at the moment.
David Lee, PhD principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Group Cognitive Behavioral Therapy, General Health Education and Transdermal Nicotine Patch in people with Smoking Cessation, run by University of Miami at 2 sites 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 6 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 24 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Number of Participants Reporting 7 Day Point Prevalence Abstinence (time frame: 12-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 NCT02511236, 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 24 Jun 2021.