Tobacco UseNCT03734666
Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation
A study testing Mindfulness Based Relapse Prevention - Smoking and Alcohol and Cognitive Behavioral Therapy in people with Tobacco Use and Alcohol Use, Unspecified, run by H. Lee Moffitt Cancer Center and Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to develop a treatment that can effectively help people reduce their alcohol use and quit smoking. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Alcohol Use, Unspecified
- What is being tested?
- Mindfulness Based Relapse Prevention - Smoking and Alcohol and Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jan 2019to 4 Nov 2021
- Phase
- Interventional
- 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
- 18 years of age or older
- Currently smoking 3 or more cigarettes per day for the past year.
- Carbon monoxide level >/= 8 ppm(parts per million); should carbon monoxide level yield a result less than 8 ppm, participant will be asked to submit a urine sample to determine contine levels and the result must be >/ level 3
- Participant must be motivated to quit smoking and decrease alcohol use within the next 60 days
- If male, consume >/= 5 drinks and if female consume >/= 4 drinks on at least 1 occasion in the past month
- Willing and able to attend the 8 weekly group sessions
Show all 18Show fewer
- Valid home address in the Tampa Bay area
- Functioning telephone number
- Can speak, read and write in English
- 18 years of age or older
- Currently smoking 3 or more cigarettes per day for the past year.
- Motivated to quit smoking and decrease alcohol use within the next 60 days
- If male, consumes >/= 5 drinks and if female consumes >/= 4 drinks on at least 1 occasion in the past month
- Willingness and ability to attend 8 weekly video group sessions
- Willingness and ability to use an email account for study materials
- Valid address
- Functioning telephone number
- Can speak, read and write in English
Who cannot join
- Unable to wear nicotine patch
- Participants who have an active substance use disorder other than an alcohol use disorder
- Participants who have an active psychotic disorder
- Current use of tobacco cessation medications
- Pregnant or nursing
- Participants who have a household member already enrolled in the study.
- In rare cases, study staff might exclude a participant for a reason not specified here
Trial locations and contacts
1 site in 1 country.
United States1 site
H Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612
About this study
The purpose of this study is to develop a treatment that can effectively help people reduce their alcohol use and quit smoking.
Read the detailed description
This study evaluates a mindfulness-based treatment to concurrently target cigarette smoking and alcohol use behaviors in adults.
Aim 1: Modify an existing mindfulness-based treatment to include a focus on smoking cessation and reduced alcohol use.
Aim 2: Evaluate benchmarks regarding the feasibility and acceptability of Mindfulness Based Relapse Prevention -Smoking and Alcohol Use.
Aim 3: Collect and examine descriptive data on proximal and distal variables associated with increased smoking abstinence and reduced drinking.
- Conditions
- Tobacco Use, Alcohol Use, Unspecified
- Being tested
- Mindfulness Based Relapse Prevention - Smoking and Alcohol, Cognitive Behavioral Therapy
- Keywords
- alcohol drinking, quit smoking
- Medical subject headings
- Tobacco Use, 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 - Smoking and AlcoholBehavioural
Also called MBRP
Mindfulness Based Relapse Prevention (MBRP) is a treatment for preventing relapse in addictive disorders that integrates mindfulness meditation with standard relapse prevention practices.
Cognitive Behavioral TherapyBehavioural
Also called CBT
Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Relapse Prevention | Experimental | Participants will receive Mindfulness Based Relapse Prevention (MBRP), an existing substance use treatment, which has been modified to focus explicitly on smoking cessation and reduced alcohol use, creating Mindfulness Based Relapse Prevention - Smoking and Alcohol (MBRP-SA). Receives: Behavioral: Mindfulness Based Relapse Prevention - Smoking and Alcohol |
| Cognitive Behavioral Therapy | Active comparator | Participants will receive Cognitive Behavioral Therapy (CBT) a well-established and commonly used treatment for substance abuse behaviors that utilizes problem solving and coping skills. Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aim 2: Number of Participants Scoring >3
Number of participants scoring >3. Patient satisfaction will be determined through a score on the Client Satisfaction Questionnaire Version 8 (Attkinson \& Greenfield), where participants respond to 8 items on a 4-point scale (1=very dissatisfied; 4=very satisfied). Results reported indicate clients with a patient satisfaction score over 80%.
Measured: End of Treatment at 8 Weeks
Aim 2: Rate of Recruitment of Eligible Participants
Rate of recruitment was measured by calculating the average of eligible participants who were recruited per week
Measured: 20 weeks
Aim 2: Participant Retention
Percentage of participants retained through follow-up
Measured: End of study at Week 16 Follow-up
Aim 2: Percentage of Participants That Completed Questionnaires
Percentage of participants who completed questionnaires at week 16
Measured: End of study at Week 16 Follow-up
Secondary outcomes (4)
Aim 3: Percent of Smoking Abstinence End of Treatment
Participants will self-report of no smoking in the last 7 days using the 7-day point prevalence.
Measured: End of Treatment at 8 Weeks
Aim 3: Percent of Smoking Abstinence at 16 Week Follow-up
Percent of smoking abstinence, measured by biochemical verification of abstinence via saliva continine and self-report of no smoking in the past 7 days. Participants who report abstinence will be mailed a saliva continine kit to confirm abstinence at their 16 week follow up call.
Measured: At 16 week follow-up
Aim 3: Percent of Heavy Alcohol Use at End of Treatment
Percent of heavy drinking days during the prior week. Heavy drinking is defined as greater or equal to 4 drinks per day for women and greater or equal to 5 drinks per day for men.
Measured: End of Treatment at 8 Weeks
Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-up
Percent of heavy drinking days during the prior week. Heavy drinking is defined as greater or equal to 4 drinks per day for women and greater or equal to 5 drinks per day for men.
Measured: At 16 week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2018
- Study start14 Jan 2019
- Primary completion4 Nov 2021
- Study completion4 Nov 2021
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 (1)Papers the sponsor has linked to this study.
- Other trials for Tobacco UseStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Christine Vinci, PhD, Principal investigator, H. Lee Moffitt Cancer Center and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03734666
- Sponsor's protocol ID
- MCC-19630
- Other IDs
- R34AT009689
- Status last verified
- Dec 2025
- First submitted
- 5 Nov 2018
- Last updated
- 15 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vinci C, Sutton SK, Yang MJ, Baban S, Sauls R, Witkiewitz K, Brandon KO, Unrod M, Brandon TH, Wetter DW. Pilot randomized controlled trial of mindfulness-based relapse prevention vs cognitive behavioral therapy for smoking and alcohol use. Drug Alcohol Depend. 2023 Mar 1;244:109768. doi: 10.1016/j.drugalcdep.2023.109768. Epub 2023 Jan 11.
PubMed 36645978
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation
- ClinicalTrials.gov ID
- NCT03734666
- Acronym / sponsor ID
- MCC-19630
- Conditions
- Tobacco Use, Alcohol Use, Unspecified
- Keywords
- alcohol drinking, quit smoking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- H. Lee Moffitt Cancer Center and Research InstituteUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 14 Jan 2019 (actual)
- Primary completion
- 4 Nov 2021 (actual)
- Study completion
- 4 Nov 2021 (actual)
- First posted
- 8 Nov 2018 (actual)
- Results
- Posted 29 Jun 2023
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 develop a treatment that can effectively help people reduce their alcohol use and quit smoking.
Detailed description
This study evaluates a mindfulness-based treatment to concurrently target cigarette smoking and alcohol use behaviors in adults.
Aim 1: Modify an existing mindfulness-based treatment to include a focus on smoking cessation and reduced alcohol use.
Aim 2: Evaluate benchmarks regarding the feasibility and acceptability of Mindfulness Based Relapse Prevention -Smoking and Alcohol Use.
Aim 3: Collect and examine descriptive data on proximal and distal variables associated with increased smoking abstinence and reduced drinking.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Relapse Prevention | Experimental | Behavioral: Mindfulness Based Relapse Prevention - Smoking and AlcoholParticipants will receive Mindfulness Based Relapse Prevention (MBRP), an existing substance use treatment, which has been modified to focus explicitly on smoking cessation and reduced alcohol use, creating Mindfulness Based Relapse Prevention - Smoking and Alcohol (MBRP-SA). |
| Cognitive Behavioral Therapy | Active comparator | Behavioral: Cognitive Behavioral TherapyParticipants will receive Cognitive Behavioral Therapy (CBT) a well-established and commonly used treatment for substance abuse behaviors that utilizes problem solving and coping skills. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- 18 years of age or older
- Currently smoking 3 or more cigarettes per day for the past year.
- Carbon monoxide level >/= 8 ppm(parts per million); should carbon monoxide level yield a result less than 8 ppm, participant will be asked to submit a urine sample to determine contine levels and the result must be >/ level 3
- Participant must be motivated to quit smoking and decrease alcohol use within the next 60 days
- If male, consume >/= 5 drinks and if female consume >/= 4 drinks on at least 1 occasion in the past month
Key exclusion criteria (7 listed)
- Unable to wear nicotine patch
- Participants who have an active substance use disorder other than an alcohol use disorder
- Participants who have an active psychotic disorder
- Current use of tobacco cessation medications
- Pregnant or nursing
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 - Smoking and AlcoholAlso: MBRPMindfulness Based Relapse Prevention (MBRP) is a treatment for preventing relapse in addictive disorders that integrates mindfulness meditation with standard relapse prevention practices. | Behavioural | Mindfulness Based Relapse Prevention |
| Cognitive Behavioral TherapyAlso: CBTCognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts. | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
Aim 2: Number of Participants Scoring >3
Time frame: End of Treatment at 8 Weeks
Number of participants scoring >3. Patient satisfaction will be determined through a score on the Client Satisfaction Questionnaire Version 8 (Attkinson \& Greenfield), where participants respond to 8 items on a 4-point scale (1=very dissatisfied; 4=very satisfied). Results reported indicate clients with a patient satisfaction score over 80%.
Aim 2: Rate of Recruitment of Eligible Participants
Time frame: 20 weeks
Rate of recruitment was measured by calculating the average of eligible participants who were recruited per week
Aim 2: Participant Retention
Time frame: End of study at Week 16 Follow-up
Percentage of participants retained through follow-up
Aim 2: Percentage of Participants That Completed Questionnaires
Time frame: End of study at Week 16 Follow-up
Percentage of participants who completed questionnaires at week 16
4 secondary outcomes
Aim 3: Percent of Smoking Abstinence End of Treatment
Time frame: End of Treatment at 8 Weeks
Aim 3: Percent of Smoking Abstinence at 16 Week Follow-up
Time frame: At 16 week follow-up
Aim 3: Percent of Heavy Alcohol Use at End of Treatment
Time frame: End of Treatment at 8 Weeks
Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-up
Time frame: At 16 week follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36645978Vinci C, Sutton SK, Yang MJ, Baban S, Sauls R, Witkiewitz K, Brandon KO, Unrod M, Brandon TH, Wetter DW. Pilot randomized controlled trial of mindfulness-based relapse prevention vs cognitive behavioral therapy for smoking and alcohol use. Drug Alcohol Depend. 2023 Mar 1;244:109768. doi: 10.1016/j.drugalcdep.2023.109768. Epub 2023 Jan 11.
- Moffitt Cancer Center Clinical Trials WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Tobacco Use
Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Recruiting
Effectiveness of Volitional Help Sheets as an Adjunct to Treatment to Promote Behavior Change: A Pilot Study on Smoking
Tobacco Dependence
Not yet recruiting
Impacto 2.0: Mobile Smoking Cessation Across Texas
Cigarette Smoking, Smoking Cessation
Active, not recruiting
Vaping Cessation Using the Ottawa Model for Smoking Cessation Among E-Cigarette Users
Tobacco Smoking, Vaping
Not yet recruitingEarly Phase 1
Lung Health and Breath Biomarkers: Acute Effects of Inhaled Cannabis
Cannabis Use, Tobacco
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.
Christine Vinci, PhD principal investigator
H. Lee Moffitt Cancer Center and Research Institute
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 - Smoking and Alcohol and Cognitive Behavioral Therapy in people with Tobacco Use and Alcohol Use, Unspecified, 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 18 inclusion and 7 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 15 Jan 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?
Yes. Results are posted in the registry (first posted 29 Jun 2023). 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?
Aim 2: Number of Participants Scoring >3 (time frame: End of Treatment at 8 Weeks). The study lists 4 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 NCT03734666, 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 15 Jan 2026.