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

Overview

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

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: November 4, 2021

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.

Interventions

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

Arms, Groups and Cohorts

  • 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).
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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

Secondary Measures

  • Aim 3: Percent of Smoking Abstinence End of Treatment
    • Time Frame: End of Treatment at 8 Weeks
    • Participants will self-report of no smoking in the last 7 days using the 7-day point prevalence.
  • Aim 3: Percent of Smoking Abstinence at 16 Week Follow-up
    • Time Frame: 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.
  • Aim 3: Percent of Heavy Alcohol Use at End of Treatment
    • Time Frame: End of Treatment at 8 Weeks
    • 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.
  • Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-up
    • Time Frame: 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • H. Lee Moffitt Cancer Center and Research Institute
  • Collaborator
    • National Institutes of Health (NIH)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Christine Vinci, PhD, Principal Investigator, H. Lee Moffitt Cancer Center and Research Institute

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