Smoking CessationNCT07447635
Testing an MBI for Smoking Cessation and Alcohol Use Among Cancer Survivors
A study testing Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) and Quitline Support in people with Smoking Cessation and Alcohol Use, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
This study will examine the efficacy of Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) compared to standard care among cancer survivors who smoke cigarettes and engage in at-risk alcohol use. 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, Alcohol Use
- What is being tested?
- Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) and Quitline Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2026to Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- History of a cancer diagnosis at any point in lifetime
- Smoked ≥1 cigarette/day in past month
- At least one binge drinking episode in past month or exceeds weekly drinking limits
- Motivated to quit smoking and modify alcohol use in next 30 days
- Valid home address in Florida
- English-speaking, reading, and writing ability
Who cannot join
- Pregnancy or lactation
- Active psychotic disorder
- History of severe alcohol withdrawal
- Current use of tobacco cessation medication or other treatments to quit smoking
- End-of-life or hospice care
- Household member already enrolled
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Christine Vinci, PhD
Vani Simmons, PhD
About this study
Official title: Smoking Cessation and Alcohol Use Among Cancer Survivors: Investigating the Efficacy of a Mindfulness-Based Intervention
This study will examine the efficacy of Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) compared to standard care among cancer survivors who smoke cigarettes and engage in at-risk alcohol use. Investigators will evaluate implementation outcomes through structured stakeholder interviews across medical centers, cancer-focused organizations, and community-based programs in Florida, and will conduct a cost-assessment and an incremental cost-effectiveness analysis of the two conditions.
Read the detailed description
The primary aim of this study is to test the efficacy of MBRP-SA compared with standard care among cancer survivors, explore potential moderators, mechanisms, and predictors of treatment effects, and evaluate implementation outcomes to guide future adoption of MBRP-SA.
- Conditions
- Smoking Cessation, Alcohol Use
- Being tested
- Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA), Quitline Support
- Keywords
- Mindfulness-based intervention, Cancer survivors, Smoking cessation, Alcohol use
- Medical subject headings
- Smoking Cessation, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA)Behavioural
MBRP-SA is a nine-week, group-based mindfulness program designed to help cancer survivors quit smoking and reduce heavy alcohol use by targeting craving, stress, and habitual behavior patterns. Participants will also receive 10 weeks of nicotine replacement therapy.
Quitline SupportBehavioural
Participants will be connected to the Florida Tobacco Quitline, which provides standard evidence-based smoking cessation support, including phone-based counseling, web-based resources, and access to text-messaging programs. The Quitline also offers up to a four-week supply of nicotine replacement therapy (patches, gum, or lozenges). Participants will also receive referrals to various alcohol-related treatment options in the community.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) | Experimental | Participants randomized to this condition will receive a mindfulness-based intervention delivered in a group format via Zoom. Receives: Behavioral: Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) |
| Quitline Support | Experimental | Participants randomized to this condition will be connected to the Florida Tobacco Quitline for smoking cessation services, as well as receive community referrals for alcohol use treatment. Receives: Behavioral: Quitline Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biochemically Confirmed 7-Day Point Prevalence Smoking Abstinence
Self-reported no combustible tobacco use in the past 7 days, verified with saliva cotinine <10 ng/mL.
Measured: 6 months post treatment
Percent Heavy Drinking Days (Past 4 Weeks)
Percentage of days in the past 4 weeks meeting heavy drinking criteria (≥5 drinks for men; ≥4 drinks for women)
Measured: 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start15 May 2026
- Primary completionDec 2029 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by H. Lee Moffitt Cancer Center and Research InstituteThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Florida Biomedical Research Program - James & Esther King
- Responsible party
- Sponsor
- Investigators
- Christine Vinci, PhD, Principal investigator, Moffitt Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07447635
- Sponsor's protocol ID
- MCC-23894
- Status last verified
- May 2026
- First submitted
- 26 Feb 2026
- Last updated
- 18 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Smoking Cessation and Alcohol Use Among Cancer Survivors: Investigating the Efficacy of a Mindfulness-Based Intervention
- ClinicalTrials.gov ID
- NCT07447635
- Acronym / sponsor ID
- MCC-23894
- Conditions
- Smoking Cessation, Alcohol Use
- Keywords
- Mindfulness-based intervention, Cancer survivors, Smoking cessation, Alcohol use
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- Florida Biomedical Research Program - James & Esther King
- Study start
- 15 May 2026 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 3 Mar 2026 (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.
This study will examine the efficacy of Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) compared to standard care among cancer survivors who smoke cigarettes and engage in at-risk alcohol use. Investigators will evaluate implementation outcomes through structured stakeholder interviews across medical centers, cancer-focused organizations, and community-based programs in Florida, and will conduct a cost-assessment and an incremental cost-effectiveness analysis of the two conditions.
Detailed description
The primary aim of this study is to test the efficacy of MBRP-SA compared with standard care among cancer survivors, explore potential moderators, mechanisms, and predictors of treatment effects, and evaluate implementation outcomes to guide future adoption of MBRP-SA.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) | Experimental | Behavioral: Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA)Participants randomized to this condition will receive a mindfulness-based intervention delivered in a group format via Zoom. |
| Quitline Support | Experimental | Behavioral: Quitline SupportParticipants randomized to this condition will be connected to the Florida Tobacco Quitline for smoking cessation services, as well as receive community referrals for alcohol use treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years old
- History of a cancer diagnosis at any point in lifetime
- Smoked ≥1 cigarette/day in past month
- At least one binge drinking episode in past month or exceeds weekly drinking limits
- Motivated to quit smoking and modify alcohol use in next 30 days
Key exclusion criteria (6 listed)
- Pregnancy or lactation
- Active psychotic disorder
- History of severe alcohol withdrawal
- Current use of tobacco cessation medication or other treatments to quit smoking
- End-of-life or hospice care
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 |
|---|---|---|
| Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA)MBRP-SA is a nine-week, group-based mindfulness program designed to help cancer survivors quit smoking and reduce heavy alcohol use by targeting craving, stress, and habitual behavior patterns. Participants will also receive 10 weeks of nicotine replacement therapy. | Behavioural | Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) |
| Quitline SupportParticipants will be connected to the Florida Tobacco Quitline, which provides standard evidence-based smoking cessation support, including phone-based counseling, web-based resources, and access to text-messaging programs. The Quitline also offers up to a four-week supply of nicotine replacement therapy (patches, gum, or lozenges). Participants will also receive referrals to various alcohol-related treatment options in the community. | Behavioural | Quitline Support |
Primary outcome
Biochemically Confirmed 7-Day Point Prevalence Smoking Abstinence
Time frame: 6 months post treatment
Self-reported no combustible tobacco use in the past 7 days, verified with saliva cotinine <10 ng/mL.
Percent Heavy Drinking Days (Past 4 Weeks)
Time frame: 6 months post treatment
Percentage of days in the past 4 weeks meeting heavy drinking criteria (≥5 drinks for men; ≥4 drinks for women)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
Related trials for Smoking Cessation
Active, not recruiting
An Interactive Smartphone Application to Motivate Smokers to Quit
Smoking Cessation, Smoking Behaviors
Not yet recruiting
Comparing the Efficacy of a Conversational Agent (QuitBot) Versus Standard Health Education on Smoking Cessation Among Medical Students; A Randomized Controlled Trial.
Conversational Agent, Smoking Cessation
Enrolling by invitationObservational study
Using Smartwatches to Monitor Smoking in Real-life Situations
Smoking
Active, not recruitingPhase 3
Early Withdrawal Exposure and Negative Affect Withdrawal (NAW) Regulation Training for Smoking Cessation
Tobacco Dependence
Active, not recruitingEarly Phase 1
Smoking Cessation Intervention During Low Dose CT (LDCT) Screening for Lung Cancer
Smoking Cessation
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.
Christine Vinci, PhD principal investigator
Moffitt Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-Based Relapse Prevention for Smoking and Alcohol (MBRP-SA) and Quitline Support in people with Smoking Cessation and Alcohol Use, run by H. Lee Moffitt Cancer Center and Research Institute 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 7 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: looking for participants now, as of the sponsor's last update on 18 May 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Skye Dougan, MPH (813-745-4376, Skye.Dougan@moffitt.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically Confirmed 7-Day Point Prevalence Smoking Abstinence (time frame: 6 months post treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 May 2026.