Trial Outcomes & Findings for Alcohol, Inflammation, and Mindfulness Study (AIM) (NCT NCT02994043)

NCT ID: NCT02994043

Last Updated: 2023-01-19

Results Overview

Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 182 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2023-01-19

Participant Flow

Participant milestones

Measure	Mindfulness-Based Relapse Prevention Mindfulness-Based Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.	Relapse Prevention Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.
Overall Study STARTED	90	92
Overall Study COMPLETED	71	75
Overall Study NOT COMPLETED	19	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Alcohol, Inflammation, and Mindfulness Study (AIM)

Baseline characteristics by cohort

Measure	MBRP n=90 Participants Mindfulness Plus Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.	Relapse Prevention n=92 Participants Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.	Total n=182 Participants Total of all reporting groups
Age, Continuous	44.1 years STANDARD_DEVIATION 10.0 • n=5 Participants	44.2 years STANDARD_DEVIATION 10.3 • n=7 Participants	44.2 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	48 Participants n=7 Participants	88 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants	44 Participants n=7 Participants	94 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	84 Participants n=5 Participants	84 Participants n=7 Participants	168 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)

Outcome measures

Measure	Mindfulness-Based Relapse Prevention n=90 Participants Mindfulness-Based Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.	Relapse Prevention n=92 Participants Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.
Heavy Drinking Days at Baseline	12.6 Heavy Drinking Days Standard Deviation 10.3	11.7 Heavy Drinking Days Standard Deviation 10.5

PRIMARY outcome

Timeframe: Week 4

Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)

Outcome measures

Measure	Mindfulness-Based Relapse Prevention n=80 Participants Mindfulness-Based Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.	Relapse Prevention n=87 Participants Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.
Heavy Drinking Days at Week 4	7.8 Heavy Drinking Days Standard Deviation 8.2	7.6 Heavy Drinking Days Standard Deviation 8.5

PRIMARY outcome

Timeframe: Week 8

Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)

Outcome measures

Measure	Mindfulness-Based Relapse Prevention n=71 Participants Mindfulness-Based Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.	Relapse Prevention n=75 Participants Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.
Heavy Drinking Days at Week 8	6.5 Heavy Drinking Days Standard Deviation 7.9	5.3 Heavy Drinking Days Standard Deviation 7.6

PRIMARY outcome

Timeframe: Week 20

Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)

Outcome measures

Measure	Mindfulness-Based Relapse Prevention n=61 Participants Mindfulness-Based Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.	Relapse Prevention n=57 Participants Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.
Heavy Drinking Days at Week 20	6.1 Heavy Drinking Days Standard Deviation 8.0	7.3 Heavy Drinking Days Standard Deviation 8.8

PRIMARY outcome

Timeframe: Week 32

Timeline Follow-back (TLFB) measure of heavy drinking days in the last month (4+ for women, 5+ for men)

Outcome measures

Measure	Mindfulness-Based Relapse Prevention n=58 Participants Mindfulness-Based Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.	Relapse Prevention n=50 Participants Relapse Prevention Therapy: An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.
Heavy Drinking Days at Week 32	4.7 Heavy Drinking Days Standard Deviation 6.5	7.7 Heavy Drinking Days Standard Deviation 8.2

Adverse Events

Mindfulness-Based Relapse Prevention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Relapse Prevention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jamie Laurin

University of Colorado Denver

Phone: 303-724-3183

Email: JAIME.LAURIN@CUANSCHUTZ.EDU

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place