Alcohol Use, Unspecified, Tobacco Use
Conditions
Keywords
alcohol drinking, quit smoking
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.
Interventions
BEHAVIORALMindfulness 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.
BEHAVIORALCognitive Behavioral Therapy
Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.
Sponsors
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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: 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: Participant Retention | End of study at Week 16 Follow-up | Percentage of participants retained through follow-up |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 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: 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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).
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. | 35 |
| 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.
Cognitive Behavioral Therapy: Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts. | 32 |
| Total | 67 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 12 | 12 |
| Overall Study | Other | 7 | 4 |
Baseline characteristics
| Characteristic | Mindfulness Based Relapse Prevention | Total | Cognitive Behavioral Therapy |
|---|---|---|---|
| Age, Continuous | 44.7 years STANDARD_DEVIATION 9.8 | 44.1 years STANDARD_DEVIATION 9.5 | 43.3 years STANDARD_DEVIATION 9.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 8 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 59 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 18 Participants | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 6 Participants | 4 Participants |
| Race (NIH/OMB) White | 23 Participants | 43 Participants | 20 Participants |
| Region of Enrollment United States | 35 participants | 67 participants | 32 participants |
| Sex/Gender, Customized Female | 23 Participants | 46 Participants | 23 Participants |
| Sex/Gender, Customized Male | 11 Participants | 20 Participants | 9 Participants |
| Sex/Gender, Customized Transgender Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 32 |
| other Total, other adverse events | 1 / 35 | 0 / 32 |
| serious Total, serious adverse events | 1 / 35 | 3 / 32 |
Outcome results
Primary
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%.
Time frame: End of Treatment at 8 Weeks
Population: Number of participants analyzed who responded to the survey
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mindfulness Based Relapse Prevention | Aim 2: Number of Participants Scoring >3 | 18 participants |
| Cognitive Behavioral Therapy | Aim 2: Number of Participants Scoring >3 | 16 participants |
Primary
Aim 2: Participant Retention
Percentage of participants retained through follow-up
Time frame: End of study at Week 16 Follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mindfulness Based Relapse Prevention | Aim 2: Participant Retention | 46 percentage of participants |
| Cognitive Behavioral Therapy | Aim 2: Participant Retention | 50 percentage of participants |
Primary
Aim 2: Percentage of Participants That Completed Questionnaires
Percentage of participants who completed questionnaires at week 16
Time frame: End of study at Week 16 Follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mindfulness Based Relapse Prevention | Aim 2: Percentage of Participants That Completed Questionnaires | 34.7 percentage of participants |
| Cognitive Behavioral Therapy | Aim 2: Percentage of Participants That Completed Questionnaires | 31.4 percentage of participants |
Primary
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
Time frame: 20 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mindfulness Based Relapse Prevention | Aim 2: Rate of Recruitment of Eligible Participants | 6 participants recruited per week |
Secondary
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.
Time frame: At 16 week follow-up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mindfulness Based Relapse Prevention | Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-up | 5.1 percentage of heavy drinking days |
| Cognitive Behavioral Therapy | Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-up | 4.6 percentage of heavy drinking days |
Secondary
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.
Time frame: End of Treatment at 8 Weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Mindfulness Based Relapse Prevention | Aim 3: Percent of Heavy Alcohol Use at End of Treatment | 4 percentage of heavy drinking days |
| Cognitive Behavioral Therapy | Aim 3: Percent of Heavy Alcohol Use at End of Treatment | 6.3 percentage of heavy drinking days |
Secondary
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.
Time frame: At 16 week follow-up
Population: Non-responders assumed to be smoking
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mindfulness Based Relapse Prevention | Aim 3: Percent of Smoking Abstinence at 16 Week Follow-up | 14.3 percentage of participants |
| Cognitive Behavioral Therapy | Aim 3: Percent of Smoking Abstinence at 16 Week Follow-up | 3.1 percentage of participants |
Secondary
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.
Time frame: End of Treatment at 8 Weeks
Population: Non-responders assumed to be smoking
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Mindfulness Based Relapse Prevention | Aim 3: Percent of Smoking Abstinence End of Treatment | 34.3 percentage of participants |
| Cognitive Behavioral Therapy | Aim 3: Percent of Smoking Abstinence End of Treatment | 31.3 percentage of participants |