Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation
- Conditions
- Alcohol Use, UnspecifiedTobacco Use
- Registration Number
- NCT03734666
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 67
Not provided
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Aim 2: Participant Retention End of study at Week 16 Follow-up Percentage of participants retained through follow-up
Aim 2: Rate of Recruitment of Eligible Participants 20 weeks Rate of recruitment was measured by calculating the average of eligible participants who were recruited per week
Aim 2: Number of Participants Scoring >3 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: Percentage of Participants That Completed Questionnaires End of study at Week 16 Follow-up Percentage of participants who completed questionnaires at week 16
- Secondary Outcome Measures
Name Time Method Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-up 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.
Aim 3: Percent of Heavy Alcohol Use at End of Treatment 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: Percent of Smoking Abstinence at 16 Week Follow-up 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 Smoking Abstinence End of Treatment End of Treatment at 8 Weeks Participants will self-report of no smoking in the last 7 days using the 7-day point prevalence.
Trial Locations
- Locations (1)
H Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States
H Lee Moffitt Cancer Center and Research Institute🇺🇸Tampa, Florida, United States