Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation
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|ClinicalTrials.gov Identifier: NCT03734666|
Recruitment Status : Recruiting
First Posted : November 8, 2018
Last Update Posted : May 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tobacco Use Alcohol Use, Unspecified||Behavioral: Mindfulness Based Relapse Prevention - Smoking and Alcohol Behavioral: Cognitive Behavioral Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||April 30, 2021|
|Estimated Study Completion Date :||April 30, 2021|
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).
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.
Other Name: MBRP
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.
Behavioral: Cognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.
Other Name: CBT
- Aim 2: Participant Satisfaction [ Time Frame: End of treatment (Week 21) ]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).
- Aim 2: Rate of Recruitment [ Time Frame: End of recruitment, Year 3 ]Rate of recruitment per month
- Aim 2: Participant Retention [ Time Frame: End of study, Year 3 ]Number of participants retained through follow-up
- Aim 2: Questionnaire Completion [ Time Frame: End of study, Year 3 ]Percentage of questionnaires completed
- Aim 3: Rate of Smoking Abstinence [ Time Frame: End of treatment, 16 week follow-up ]Rate of smoking abstinence, measured by carbon monoxide (CO) verification and self-report of no smoking in the past 7 days. CO readings of less than 8 ppm provides biochemical verification of smoking abstinence.
- Aim 3: Rate of Alcohol Use [ Time Frame: End of treatment, 16 week follow-up ]Rate of Alcohol use, measured by self-report of no alcohol consumption in the past 7 days at end of study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03734666
|United States, Florida|
|H Lee Moffitt Cancer Center and Research Institute||Recruiting|
|Tampa, Florida, United States, 33612|
|Contact: Laura Hernandez 813-745-8280 Laura.Hernandez@moffitt.org|
|Principal Investigator: Christine Vinci, PhD|
|Sub-Investigator: Thomas Brandon, PhD|
|Sub-Investigator: David Drobes, PhD|
|Sub-Investigator: Steve Sutton, PhD|
|Principal Investigator:||Christine Vinci, PhD||H. Lee Moffitt Cancer Center and Research Institute|