Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Tobacco Use
- Sponsor
- H. Lee Moffitt Cancer Center and Research Institute
- Enrollment
- 67
- Locations
- 1
- Primary Endpoint
- Aim 2: Participant Retention
- Status
- Completed
- Last Updated
- 3 months ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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:
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
Outcomes
Primary Outcomes
Aim 2: Participant Retention
Time Frame: End of study at Week 16 Follow-up
Percentage of participants retained through follow-up
Aim 2: Rate of Recruitment of Eligible Participants
Time Frame: 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
Time Frame: 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
Time Frame: End of study at Week 16 Follow-up
Percentage of participants who completed questionnaires at week 16
Secondary Outcomes
- Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-up(At 16 week follow-up)
- Aim 3: Percent of Heavy Alcohol Use at End of Treatment(End of Treatment at 8 Weeks)
- Aim 3: Percent of Smoking Abstinence at 16 Week Follow-up(At 16 week follow-up)
- Aim 3: Percent of Smoking Abstinence End of Treatment(End of Treatment at 8 Weeks)