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

Primary Purpose

Tobacco Use, Alcohol Use, Unspecified

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Based Relapse Prevention - Smoking and Alcohol
Cognitive Behavioral Therapy
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Tobacco Use focused on measuring alcohol drinking, quit smoking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • H Lee Moffitt Cancer Center and Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness Based Relapse Prevention

Cognitive Behavioral Therapy

Arm Description

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).

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.

Outcomes

Primary Outcome Measures

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%.
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
Aim 2: Participant Retention
Percentage of participants retained through follow-up
Aim 2: Percentage of Participants That Completed Questionnaires
Percentage of participants who completed questionnaires at week 16

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
November 5, 2018
Last Updated
June 9, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT03734666
Brief Title
Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation
Official Title
Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 14, 2019 (Actual)
Primary Completion Date
November 4, 2021 (Actual)
Study Completion Date
November 4, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Use, Alcohol Use, Unspecified
Keywords
alcohol drinking, quit smoking

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Based Relapse Prevention
Arm Type
Experimental
Arm Description
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).
Arm Title
Cognitive Behavioral Therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Based Relapse Prevention - Smoking and Alcohol
Other Intervention Name(s)
MBRP
Intervention Description
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
Intervention Name(s)
Cognitive Behavioral Therapy
Other Intervention Name(s)
CBT
Intervention Description
Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.
Primary Outcome Measure Information:
Title
Aim 2: Number of Participants Scoring >3
Description
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%.
Time Frame
End of Treatment at 8 Weeks
Title
Aim 2: Rate of Recruitment of Eligible Participants
Description
Rate of recruitment was measured by calculating the average of eligible participants who were recruited per week
Time Frame
20 weeks
Title
Aim 2: Participant Retention
Description
Percentage of participants retained through follow-up
Time Frame
End of study at Week 16 Follow-up
Title
Aim 2: Percentage of Participants That Completed Questionnaires
Description
Percentage of participants who completed questionnaires at week 16
Time Frame
End of study at Week 16 Follow-up
Secondary Outcome Measure Information:
Title
Aim 3: Percent of Smoking Abstinence End of Treatment
Description
Participants will self-report of no smoking in the last 7 days using the 7-day point prevalence.
Time Frame
End of Treatment at 8 Weeks
Title
Aim 3: Percent of Smoking Abstinence at 16 Week Follow-up
Description
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.
Time Frame
At 16 week follow-up
Title
Aim 3: Percent of Heavy Alcohol Use at End of Treatment
Description
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.
Time Frame
End of Treatment at 8 Weeks
Title
Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-up
Description
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.
Time Frame
At 16 week follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Vinci, PhD
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://moffitt.org/clinical-trials-research/clinical-trials/
Description
Moffitt Cancer Center Clinical Trials Website

Learn more about this trial

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

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