Trial Outcomes & Findings for Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation (NCT NCT03734666)
NCT ID: NCT03734666
Last Updated: 2026-01-15
Results Overview
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%.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
End of Treatment at 8 Weeks
Results posted on
2026-01-15
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
35
|
32
|
|
Overall Study
COMPLETED
|
16
|
16
|
|
Overall Study
NOT COMPLETED
|
19
|
16
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Other
|
7
|
4
|
|
Overall Study
Lost to Follow-up
|
12
|
12
|
Baseline Characteristics
Development of a Mindfulness-Based Treatment for the Reduction of Alcohol Use and Smoking Cessation
Baseline characteristics by cohort
| Measure |
Mindfulness Based Relapse Prevention
n=35 Participants
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.
|
Cognitive Behavioral Therapy
n=32 Participants
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.
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.7 years
STANDARD_DEVIATION 9.8 • n=14 Participants
|
43.3 years
STANDARD_DEVIATION 9.3 • n=10 Participants
|
44.1 years
STANDARD_DEVIATION 9.5 • n=24 Participants
|
|
Sex/Gender, Customized
Male
|
11 Participants
n=14 Participants
|
9 Participants
n=10 Participants
|
20 Participants
n=24 Participants
|
|
Sex/Gender, Customized
Female
|
23 Participants
n=14 Participants
|
23 Participants
n=10 Participants
|
46 Participants
n=24 Participants
|
|
Sex/Gender, Customized
Transgender Male
|
1 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=14 Participants
|
4 Participants
n=10 Participants
|
8 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=14 Participants
|
28 Participants
n=10 Participants
|
59 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=14 Participants
|
8 Participants
n=10 Participants
|
18 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
23 Participants
n=14 Participants
|
20 Participants
n=10 Participants
|
43 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=14 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=14 Participants
|
4 Participants
n=10 Participants
|
6 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
35 participants
n=14 Participants
|
32 participants
n=10 Participants
|
67 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: End of Treatment at 8 WeeksPopulation: Number of participants analyzed who responded to the survey
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%.
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention
n=19 Participants
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.
|
Cognitive Behavioral Therapy
n=16 Participants
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.
|
|---|---|---|
|
Aim 2: Number of Participants Scoring >3
|
18 participants
|
16 participants
|
PRIMARY outcome
Timeframe: 20 weeksRate of recruitment was measured by calculating the average of eligible participants who were recruited per week
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention
n=121 Participants
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.
|
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.
|
|---|---|---|
|
Aim 2: Rate of Recruitment of Eligible Participants
|
6 participants recruited per week
|
—
|
PRIMARY outcome
Timeframe: End of study at Week 16 Follow-upPercentage of participants retained through follow-up
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention
n=35 Participants
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.
|
Cognitive Behavioral Therapy
n=32 Participants
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.
|
|---|---|---|
|
Aim 2: Participant Retention
|
46 percentage of participants
|
50 percentage of participants
|
PRIMARY outcome
Timeframe: End of study at Week 16 Follow-upPercentage of participants who completed questionnaires at week 16
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention
n=35 Participants
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.
|
Cognitive Behavioral Therapy
n=32 Participants
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.
|
|---|---|---|
|
Aim 2: Percentage of Participants That Completed Questionnaires
|
34.7 percentage of participants
|
31.4 percentage of participants
|
SECONDARY outcome
Timeframe: End of Treatment at 8 WeeksPopulation: Non-responders assumed to be smoking
Participants will self-report of no smoking in the last 7 days using the 7-day point prevalence.
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention
n=35 Participants
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.
|
Cognitive Behavioral Therapy
n=32 Participants
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.
|
|---|---|---|
|
Aim 3: Percent of Smoking Abstinence End of Treatment
|
34.3 percentage of participants
|
31.3 percentage of participants
|
SECONDARY outcome
Timeframe: At 16 week follow-upPopulation: Non-responders assumed to be smoking
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.
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention
n=35 Participants
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.
|
Cognitive Behavioral Therapy
n=32 Participants
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.
|
|---|---|---|
|
Aim 3: Percent of Smoking Abstinence at 16 Week Follow-up
|
14.3 percentage of participants
|
3.1 percentage of participants
|
SECONDARY outcome
Timeframe: End of Treatment at 8 WeeksPercent 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.
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention
n=18 Participants
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.
|
Cognitive Behavioral Therapy
n=16 Participants
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.
|
|---|---|---|
|
Aim 3: Percent of Heavy Alcohol Use at End of Treatment
|
4 percentage of heavy drinking days
Interval 0.0 to 100.0
|
6.3 percentage of heavy drinking days
Interval 0.0 to 100.0
|
SECONDARY outcome
Timeframe: At 16 week follow-upPercent 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.
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention
n=16 Participants
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.
|
Cognitive Behavioral Therapy
n=14 Participants
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.
|
|---|---|---|
|
Aim 3: Percentage of Heavy Alcohol Use at 16 Week Follow-up
|
5.1 percentage of heavy drinking days
Interval 0.0 to 100.0
|
4.6 percentage of heavy drinking days
Interval 0.0 to 100.0
|
Adverse Events
Mindfulness Based Relapse Prevention
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Cognitive Behavioral Therapy
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mindfulness Based Relapse Prevention
n=35 participants at risk
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.
|
Cognitive Behavioral Therapy
n=32 participants at risk
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.
|
|---|---|---|
|
General disorders
General Disorders and administration site conditions - Other
|
2.9%
1/35 • Number of events 1 • Adverse Events were collected from start of treatment to end of treatment, an average of 16 weeks.
|
0.00%
0/32 • Adverse Events were collected from start of treatment to end of treatment, an average of 16 weeks.
|
|
Renal and urinary disorders
Renal calculi
|
0.00%
0/35 • Adverse Events were collected from start of treatment to end of treatment, an average of 16 weeks.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from start of treatment to end of treatment, an average of 16 weeks.
|
|
Musculoskeletal and connective tissue disorders
Torn Ligament
|
0.00%
0/35 • Adverse Events were collected from start of treatment to end of treatment, an average of 16 weeks.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from start of treatment to end of treatment, an average of 16 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/35 • Adverse Events were collected from start of treatment to end of treatment, an average of 16 weeks.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from start of treatment to end of treatment, an average of 16 weeks.
|
|
General disorders
Flu like symptoms
|
0.00%
0/35 • Adverse Events were collected from start of treatment to end of treatment, an average of 16 weeks.
|
3.1%
1/32 • Number of events 1 • Adverse Events were collected from start of treatment to end of treatment, an average of 16 weeks.
|
Other adverse events
| Measure |
Mindfulness Based Relapse Prevention
n=35 participants at risk
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.
|
Cognitive Behavioral Therapy
n=32 participants at risk
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.
|
|---|---|---|
|
General disorders
Pain
|
2.9%
1/35 • Number of events 1 • Adverse Events were collected from start of treatment to end of treatment, an average of 16 weeks.
|
0.00%
0/32 • Adverse Events were collected from start of treatment to end of treatment, an average of 16 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place