Trial Outcomes & Findings for Biobehavioral Pathways Underlying Alcohol Use and Health (NCT NCT05135767)
NCT ID: NCT05135767
Last Updated: 2024-09-19
Results Overview
Feasibility will be evaluated through the percentage of those who are screened as eligible for the study who enroll as participants in the study. The target enrollment rate is greater than or equal to 60% of screen eligible.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
37 participants
Primary outcome timeframe
3 months
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
Alcohol Use Disorder Only
Individuals in the Alcohol Use Disorder Only arm will meet criteria for alcohol use disorder but will not show evidence of advanced alcohol-associated liver disease. Both arms receive the same brief motivational intervention with personalized feedback.
|
Alcohol Associated Liver Disease + Alcohol Use Disorder
Individuals in the Alcohol Associated Liver Disease + Alcohol Use Disorder arm will meet criteria for alcohol use disorder and also show evidence of advanced alcohol-associated liver disease. Both arms receive the same brief motivational intervention with personalized feedback.
|
|---|---|---|
|
Baseline
STARTED
|
29
|
8
|
|
Baseline
COMPLETED
|
28
|
5
|
|
Baseline
NOT COMPLETED
|
1
|
3
|
|
Active Study Phase
STARTED
|
28
|
5
|
|
Active Study Phase
Week 1
|
27
|
5
|
|
Active Study Phase
Week 2
|
27
|
5
|
|
Active Study Phase
COMPLETED
|
26
|
5
|
|
Active Study Phase
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Alcohol Use Disorder Only
Individuals in the Alcohol Use Disorder Only arm will meet criteria for alcohol use disorder but will not show evidence of advanced alcohol-associated liver disease. Both arms receive the same brief motivational intervention with personalized feedback.
|
Alcohol Associated Liver Disease + Alcohol Use Disorder
Individuals in the Alcohol Associated Liver Disease + Alcohol Use Disorder arm will meet criteria for alcohol use disorder and also show evidence of advanced alcohol-associated liver disease. Both arms receive the same brief motivational intervention with personalized feedback.
|
|---|---|---|
|
Baseline
Lost to Follow-up
|
1
|
1
|
|
Baseline
Withdrawal by Subject
|
0
|
2
|
|
Active Study Phase
Lost to Follow-up
|
2
|
0
|
Baseline Characteristics
Biobehavioral Pathways Underlying Alcohol Use and Health
Baseline characteristics by cohort
| Measure |
Alcohol Use Disorder Only
n=29 Participants
Individuals in the Alcohol Use Disorder Only arm will meet criteria for alcohol use disorder but will not show evidence of advanced alcohol-associated liver disease. Both arms receive the same brief motivational intervention with personalized feedback.
|
Alcohol Associated Liver Disease + Alcohol Use Disorder
n=8 Participants
Individuals in the Alcohol Associated Liver Disease + Alcohol Use Disorder arm will meet criteria for alcohol use disorder and also show evidence of advanced alcohol-associated liver disease. Both arms receive the same brief motivational intervention with personalized feedback.
|
Total
n=37 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Continuous
|
44.3 years
n=99 Participants
|
58.3 years
n=107 Participants
|
47.3 years
n=206 Participants
|
|
Sex/Gender, Customized
Sex/Gender, Customized · Cisgender Man
|
14 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Sex/Gender, Customized · Cisgender Woman
|
14 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Sex/Gender, Customized
Sex/Gender, Customized · Transgender Woman
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
21 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=99 Participants
|
8 participants
n=107 Participants
|
37 participants
n=206 Participants
|
|
Recruitment Source
Community
|
29 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Recruitment Source
Clinic
|
0 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Overall Number of Participants Analyzed in each Arm/Group is the number of participants who screened eligible for the study.
Feasibility will be evaluated through the percentage of those who are screened as eligible for the study who enroll as participants in the study. The target enrollment rate is greater than or equal to 60% of screen eligible.
Outcome measures
| Measure |
Alcohol Use Disorder Only
n=29 Participants
Individuals in the Alcohol Use Disorder Only arm will meet criteria for alcohol use disorder but will not show evidence of advanced alcohol-associated liver disease. Both arms receive the same brief motivational intervention with personalized feedback.
|
Alcohol Associated Liver Disease + Alcohol Use Disorder
n=8 Participants
Individuals in the Alcohol Associated Liver Disease + Alcohol Use Disorder arm will meet criteria for alcohol use disorder and also show evidence of advanced alcohol-associated liver disease. Both arms receive the same brief motivational intervention with personalized feedback.
|
|---|---|---|
|
Percentage of Screen Eligible Who Enroll
|
28 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Overall Number of Participants Analyzed in each Arm/Group is the number of participants who enrolled in the study, defined as screening eligible and completing baseline assessments.
Feasibility will be evaluated through the percentage of those participants who are enrolled in the study who complete the study. The target retention rate is greater than or equal to 70% of enrolled participants.
Outcome measures
| Measure |
Alcohol Use Disorder Only
n=28 Participants
Individuals in the Alcohol Use Disorder Only arm will meet criteria for alcohol use disorder but will not show evidence of advanced alcohol-associated liver disease. Both arms receive the same brief motivational intervention with personalized feedback.
|
Alcohol Associated Liver Disease + Alcohol Use Disorder
n=5 Participants
Individuals in the Alcohol Associated Liver Disease + Alcohol Use Disorder arm will meet criteria for alcohol use disorder and also show evidence of advanced alcohol-associated liver disease. Both arms receive the same brief motivational intervention with personalized feedback.
|
|---|---|---|
|
Percentage of Participants Who Complete the Study
|
26 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsPopulation: Overall Number of Participants Analyzed in each Arm/Group is the number of participants who enrolled in the study, defined as screening eligible and completing baseline assessments.
Acceptability will be evaluated through the percentage of those participants who enroll in the study who withdraw from the study. A participant is considered to have withdrawn from the study if they indicate that they no longer wish to be a part of the study (i.e., not lost to contact). The target withdrawal rate is less than or equal to 20% of enrolled participants.
Outcome measures
| Measure |
Alcohol Use Disorder Only
n=28 Participants
Individuals in the Alcohol Use Disorder Only arm will meet criteria for alcohol use disorder but will not show evidence of advanced alcohol-associated liver disease. Both arms receive the same brief motivational intervention with personalized feedback.
|
Alcohol Associated Liver Disease + Alcohol Use Disorder
n=5 Participants
Individuals in the Alcohol Associated Liver Disease + Alcohol Use Disorder arm will meet criteria for alcohol use disorder and also show evidence of advanced alcohol-associated liver disease. Both arms receive the same brief motivational intervention with personalized feedback.
|
|---|---|---|
|
Percentage of Participants Who Withdraw
|
0 Participants
|
0 Participants
|
Adverse Events
Alcohol Use Disorder Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Alcohol Associated Liver Disease + Alcohol Use Disorder
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place