Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation

The purpose of this study is to develop a treatment that can effectively help people reduce their alcohol use and quit smoking.

Study Overview

• Status: Completed
• Conditions: Tobacco Use; Alcohol Use, Unspecified
• Intervention / Treatment: Behavioral: Mindfulness Based Relapse Prevention - Smoking and Alcohol; Behavioral: Cognitive Behavioral Therapy

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 Type: Interventional
• Enrollment (Actual): 67
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33612
      • H Lee Moffitt Cancer Center and Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria Aim 1:

• 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
• Valid home address in the Tampa Bay area
• Functioning telephone number
• Can speak, read and write in English

Inclusion Criteria Aim 2:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Based Relapse Prevention; 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).	Behavioral: Mindfulness Based Relapse Prevention - Smoking and Alcohol; Mindfulness Based Relapse Prevention (MBRP) is a treatment for preventing relapse in addictive disorders that integrates mindfulness meditation with standard relapse prevention practices.; Other Names: MBRP
Active Comparator: Cognitive Behavioral Therapy; 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.	Behavioral: Cognitive Behavioral Therapy; Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.; Other Names: CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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%.	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	20 weeks
Aim 2: Participant Retention	Percentage of participants retained through follow-up	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	End of study at Week 16 Follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	At 16 week follow-up

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Institutes of Health (NIH); National Center for Complementary and Integrative Health (NCCIH)
• Investigators: Principal Investigator: Christine Vinci, PhD, H. Lee Moffitt Cancer Center and Research Institute

Publications and helpful links

General 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.

Helpful Links

• Moffitt Cancer Center Clinical Trials Website

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2019
• Primary Completion (Actual): November 4, 2021
• Study Completion (Actual): November 4, 2021

Study Registration Dates

• First Submitted: November 5, 2018
• First Submitted That Met QC Criteria: November 6, 2018
• First Posted (Actual): November 8, 2018

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: quit smoking; alcohol drinking
• Additional Relevant MeSH Terms: Drinking Behavior; Behavior; Alcohol Drinking; Tobacco Use; Organic Chemicals; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Alcohols; Ethanol; Cognitive Behavioral Therapy
• Other Study ID Numbers: MCC-19630; R34AT009689 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No