Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Names:
|
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Aim 2: Participant Satisfaction [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 [End of recruitment, Year 3]
Rate of recruitment per month
- Aim 2: Participant Retention [End of study, Year 3]
Number of participants retained through follow-up
- Aim 2: Questionnaire Completion [End of study, Year 3]
Percentage of questionnaires completed
Secondary Outcome Measures
- Aim 3: Rate of Smoking Abstinence [End of treatment, 16 week follow-up]
Rate 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: Rate of Alcohol Use [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.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | H Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | United States | 33612 |
Sponsors and Collaborators
- H. Lee Moffitt Cancer Center and Research Institute
- National Institutes of Health (NIH)
- National Center for Complementary and Integrative Health (NCCIH)
Investigators
- Principal Investigator: Christine Vinci, PhD, H. Lee Moffitt Cancer Center and Research Institute
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- MCC-19630
- R34AT009689