SmokingPhase 1/2SB2NCT01811758
Culturally Specific Interventions: African American Smokers
A Phase 1/2 study testing Culturally Specific CBT and Standard CBT in people with Smoking and Smoking Cessation, run by University of Miami at 1 site in United States.
Trial summary
The investigators expect that a culturally specific group intervention targeting African American smokers will result in greater smoking cessation rates compared to a standard intervention. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking, Smoking Cessation
- What is being tested?
- Culturally Specific CBT and Standard CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 345 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Apr 2014
- Phase
- Phase 1/2
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- self-identification as African American
- current smoker of ≥ 5 cigarettes/day or expired CO level of ≥ 8 ppm;
- age 18-65;
- able to speak and read English;
- permanent contact information;
- access to transportation by public transit or car;
- no current behavioral or pharmacological treatment ;
- interest in quitting smoking; (9) have availability to attend sessions.
Who cannot join
- enrolled in another cessation program,
- do not speak and read English,
- do not have access to transportation by car or bus to attend sessions,
- do not have childcare during session times,
- have contraindications for patch use (pregnant/breastfeeding),
- if they are in treatment for substance abuse (e.g., illicit drugs, alcohol abuse),
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- if they endorse active addiction to another substance (e.g., illicit drugs or alcohol),
- if they have been diagnosed with an acute cardiac or respiratory condition;
- people identified as having a severe mental illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Culturally Specific Interventions and Acculturation in African American Smokers
The investigators expect that a culturally specific group intervention targeting African American smokers will result in greater smoking cessation rates compared to a standard intervention.
- Conditions
- Smoking, Smoking Cessation
- Being tested
- Culturally Specific CBT, Standard CBT
- Keywords
- Culturally Specific Cognitive Behavioral Therapy, Standard Cognitive Behavioral Therapy
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Culturally Specific CBTBehavioural
Standard CBTBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Culturally Specific CBT | Experimental | Culturally specific cognitive behavioral therapy. Group format, 8 sessions, approximately 90 minutes. Up to 8-weeks of transdermal nicotine patches. Focused on African Americans: smoking patterns, health outcomes, discrimination, stress, weight concerns, cultural beliefs and practices. Receives: Behavioral: Culturally Specific CBT |
| Standard CBT (control) | Active comparator | Standard cognitive behavioral therapy. Group format, 8 sessions, approximately 90 minutes each. Up to 8-weeks of transdermal nicotine patches. Traditional CBT, with no focus on race: smoking and health, benefits of quitting, weight control, relapse prevention, coping skills. Receives: Behavioral: Standard CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
7-day point prevalence abstinence
Generalized linear mixed model of overall intervention effect.
Measured: Overall effect at 12-months
Secondary outcomes (1)
7-day point prevalence abstinence
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2013 (estimated)
- Study startAug 2011
- Primary completionSep 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 345 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- University of Minnesota
- Responsible party
- Principal investigator, Monica W. Hooper, University of Miami
- Investigators
- Monica Hooper, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01811758
- Sponsor's protocol ID
- SmokeBreak2
- Acronym
- SB2
- Status last verified
- Jul 2015
- First submitted
- 12 Mar 2013
- Last updated
- 10 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Hooper MW, Larry R, Okuyemi K, Resnicow K, Dietz NA, Robinson RG, Antoni MH. Culturally specific versus standard group cognitive behavioral therapy for smoking cessation among African Americans: an RCT protocol. BMC Psychol. 2013 Aug 21;1(1):15. doi: 10.1186/2050-7283-1-15. eCollection 2013.
PubMed 25566367
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Culturally Specific Interventions and Acculturation in African American Smokers
- ClinicalTrials.gov ID
- NCT01811758
- Acronym / sponsor ID
- SB2 / SmokeBreak2
- Conditions
- Smoking, Smoking Cessation
- Keywords
- Culturally Specific Cognitive Behavioral Therapy, Standard Cognitive Behavioral Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 345 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- University of Minnesota
- Study start
- Aug 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 15 Mar 2013 (estimated)
- 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 investigators expect that a culturally specific group intervention targeting African American smokers will result in greater smoking cessation rates compared to a standard intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Culturally Specific CBT | Experimental | Behavioral: Culturally Specific CBTCulturally specific cognitive behavioral therapy. Group format, 8 sessions, approximately 90 minutes. Up to 8-weeks of transdermal nicotine patches. Focused on African Americans: smoking patterns, health outcomes, discrimination, stress, weight concerns, cultural beliefs and practices. |
| Standard CBT (control) | Active comparator | Behavioral: Standard CBTStandard cognitive behavioral therapy. Group format, 8 sessions, approximately 90 minutes each. Up to 8-weeks of transdermal nicotine patches. Traditional CBT, with no focus on race: smoking and health, benefits of quitting, weight control, relapse prevention, coping skills. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- self-identification as African American
- current smoker of ≥ 5 cigarettes/day or expired CO level of ≥ 8 ppm;
- age 18-65;
- able to speak and read English;
- permanent contact information;
Key exclusion criteria (9 listed)
- enrolled in another cessation program,
- do not speak and read English,
- do not have access to transportation by car or bus to attend sessions,
- do not have childcare during session times,
- have contraindications for patch use (pregnant/breastfeeding),
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 |
|---|---|---|
| Culturally Specific CBT | Behavioural | Culturally Specific CBT |
| Standard CBT | Behavioural | Standard CBT (control) |
Primary outcome
7-day point prevalence abstinence
Time frame: Overall effect at 12-months
Generalized linear mixed model of overall intervention effect.
1 secondary outcome
7-day point prevalence abstinence
Time frame: 6-months
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 10 Jul 2015.
- Background: PubMed 25566367Hooper MW, Larry R, Okuyemi K, Resnicow K, Dietz NA, Robinson RG, Antoni MH. Culturally specific versus standard group cognitive behavioral therapy for smoking cessation among African Americans: an RCT protocol. BMC Psychol. 2013 Aug 21;1(1):15. doi: 10.1186/2050-7283-1-15. eCollection 2013.
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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.
Monica Hooper, PhD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Culturally Specific CBT and Standard CBT in people with Smoking and Smoking Cessation, run by University of Miami 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 8 inclusion and 9 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 10 Jul 2015. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
7-day point prevalence abstinence (time frame: Overall effect at 12-months). 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 NCT01811758, which also lists 1 linked publication.
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 10 Jul 2015.