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

NCT ID: NCT03734666

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-14
• Study Completion Date: 2021-11-04

Brief Summary

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.

Conditions

Tobacco Use; Alcohol Use, Unspecified

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Mindfulness Based Relapse Prevention - Smoking and Alcohol

Intervention Type: BEHAVIORAL

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 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.

Group Type: ACTIVE_COMPARATOR

Cognitive Behavioral Therapy

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.

Interventions

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.

Intervention Type: BEHAVIORAL

Cognitive Behavioral Therapy

Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.

Intervention Type: BEHAVIORAL

Other Intervention Names

MBRP; CBT

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Vinci, PhD

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 36645978 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

R34AT009689

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MCC-19630

Identifier Type: -

Identifier Source: org_study_id