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| ID | Type | Description | Link |
|---|---|---|---|
| R34AT009689 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
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The purpose of this study is to develop a treatment that can effectively help people reduce their alcohol use and quit smoking.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Based Relapse Prevention | Experimental | 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). |
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| Cognitive Behavioral Therapy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Relapse Prevention - Smoking and Alcohol | Behavioral | Mindfulness Based Relapse Prevention (MBRP) is a treatment for preventing relapse in addictive disorders that integrates mindfulness meditation with standard relapse prevention practices. |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | End of Treatment at 8 Weeks |
| 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 | 20 weeks |
| Aim 2: Participant Retention | Percentage of participants retained through follow-up | End of study at Week 16 Follow-up |
| Aim 2: Percentage of Participants That Completed Questionnaires | Percentage of participants who completed questionnaires at week 16 | End of study at Week 16 Follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | End of Treatment at 8 Weeks |
| Aim 3: Percent of Smoking Abstinence at 16 Week Follow-up |
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Inclusion Criteria Aim 1:
Inclusion Criteria Aim 2:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine Vinci, PhD | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36645978 | Derived | Vinci C, Sutton SK, Yang MJ, Baban S, Sauls R, Witkiewitz K, Brandon KO, Unrod M, Brandon TH, Wetter DW. Pilot randomized controlled trial of mindfulness-based relapse prevention vs cognitive behavioral therapy for smoking and alcohol use. Drug Alcohol Depend. 2023 Mar 1;244:109768. doi: 10.1016/j.drugalcdep.2023.109768. Epub 2023 Jan 11. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 1, 2021 |
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| Cognitive Behavioral Therapy | Behavioral | Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts. |
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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.
| At 16 week follow-up |
| 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. | End of Treatment at 8 Weeks |
| 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. | At 16 week follow-up |
| FG001 | 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. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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%. | Number of participants analyzed who responded to the survey | Posted | Number | participants | End of Treatment at 8 Weeks |
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| 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 | Posted | Number | participants recruited per week | 20 weeks |
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| Primary | Aim 2: Participant Retention | Percentage of participants retained through follow-up | Posted | Number | percentage of participants | End of study at Week 16 Follow-up |
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| Primary | Aim 2: Percentage of Participants That Completed Questionnaires | Percentage of participants who completed questionnaires at week 16 | Posted | Number | percentage of participants | End of study at Week 16 Follow-up |
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| 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. | Non-responders assumed to be smoking | Posted | Number | percentage of participants | End of Treatment at 8 Weeks |
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| 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. | Non-responders assumed to be smoking | Posted | Number | percentage of participants | At 16 week follow-up |
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| 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. | Posted | Mean | Full Range | percentage of heavy drinking days | End of Treatment at 8 Weeks |
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| 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. | Posted | Mean | Full Range | percentage of heavy drinking days | At 16 week follow-up |
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Adverse Events were collected from start of treatment to end of treatment, an average of 16 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 35 | 1 | 35 | 1 | 35 |
| EG001 | 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. | 0 | 32 | 3 | 32 | 0 | 32 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| General Disorders and administration site conditions - Other | General disorders | CTCAE (5.0) | Non-systematic Assessment | Participant was admitted to hospital, but did not disclose why |
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| Renal calculi | Renal and urinary disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Torn Ligament | Musculoskeletal and connective tissue disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | CTCAE (5.0) | Non-systematic Assessment |
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| Flu like symptoms | General disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain | General disorders | CTCAE (5.0) | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine Vinci | Moffitt Cancer Center | 813-745-5421 | Christine.Vinci@moffitt.org |
| Apr 21, 2023 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jan 20, 2021 | Feb 10, 2023 | ICF_001.pdf |
| ID | Term |
|---|---|
| D064424 | Tobacco Use |
| D000428 | Alcohol Drinking |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D004327 | Drinking Behavior |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Female |
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| Transgender Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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