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

Study Overview
=================
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.

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

Conditions
-----------------
Tobacco Use, Alcohol Use, Unspecified

Intervention / Treatment
-----------------
* Behavioral: Mindfulness Based Relapse Prevention - Smoking and Alcohol
* Behavioral: Cognitive Behavioral Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alcohol drinking, quit smoking