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

NCT03734666 | Completed Results

• 2 other identifiers: MCC-19630R34AT009689
• Study Type: interventional
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tobacco Use; Alcohol Use, Unspecified

Keywords

alcohol drinking; quit smoking

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Aim 3: Percent of Smoking Abstinence End of Treatment

  End of Treatment at 8 Weeks

• Aim 3: Percent of Smoking Abstinence at 16 Week Follow-up

  At 16 week follow-up

• Aim 3: Percent of Heavy Alcohol Use at End of Treatment

  End of Treatment at 8 Weeks

• Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-up

  At 16 week follow-up

Study Arms (2)

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).

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.

Behavioral: Cognitive Behavioral Therapy

Interventions

Mindfulness Based Relapse Prevention - Smoking and Alcohol BEHAVIORAL

Mindfulness Based Relapse Prevention (MBRP) is a treatment for preventing relapse in addictive disorders that integrates mindfulness meditation with standard relapse prevention practices.

Also known as: MBRP

Mindfulness Based Relapse Prevention

Cognitive Behavioral Therapy BEHAVIORAL

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

Also known as: CBT

Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

H Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Related Publications (1)

• 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.

  PMID: 36645978 DERIVED

Related Links

• Moffitt Cancer Center Clinical Trials Website

MeSH Terms

Conditions

Tobacco Use; Alcohol Drinking

Interventions

Ethanol; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavior; Drinking Behavior

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Christine Vinci
• Organization: Moffitt Cancer Center

Christine.Vinci@moffitt.org

813-745-5421

Study Officials

• Christine Vinci, PhD

  H. Lee Moffitt Cancer Center and Research Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2018
• First Posted: November 8, 2018
• Study Start: January 14, 2019
• Primary Completion: November 4, 2021
• Study Completion: November 4, 2021
• Last Updated: January 15, 2026
• Results First Posted: June 29, 2023

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)