Trial Outcomes & Findings for Pioglitazone for the Treatment of Alcohol Use Disorder (NCT NCT03864146)
NCT ID: NCT03864146
Last Updated: 2025-06-13
Results Overview
The primary outcome is change in heavy drinking days per week as measured by the Timeline Follow-back. A heavy drinking day is defined as : \>4 standard drinks in a day for men and \>3 standard drinks in a day for women
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
201 participants
Primary outcome timeframe
Change between baseline and 14 weeks
Results posted on
2025-06-13
Participant Flow
The first participant was randomized on July 26, 2019 and data were collected through March 29, 2024. Potential subjects were recruited from two VA medical centers (Long Beach and Minneapolis) and were recruited from outpatient mental health and medical clinics at each VA and through IRB approved advertisements. Also, a VA database was queried for all patients who scored greater than 3 on the AUDIT-C, recruitment letters were sent to a subset of these patients and recruited via this method.
Potential subjects who did not meet inclusion/exclusion criteria were not enrolled in the trial, this included 16 subjects who signed informed consent but did not meet criteria so a total of 185 subjects were randomized to drug
Participant milestones
| Measure |
Pioglitazone
Pioglitazone titrated to 45mg by mouth each day
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
Placebo
placebo, identical 45mg pill
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
|---|---|---|
|
Overall Study
STARTED
|
93
|
92
|
|
Overall Study
COMPLETED
|
76
|
67
|
|
Overall Study
NOT COMPLETED
|
17
|
25
|
Reasons for withdrawal
| Measure |
Pioglitazone
Pioglitazone titrated to 45mg by mouth each day
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
Placebo
placebo, identical 45mg pill
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
14
|
23
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Pioglitazone for the Treatment of Alcohol Use Disorder
Baseline characteristics by cohort
| Measure |
Pioglitazone
n=93 Participants
Pioglitazone titrated to 45mg by mouth each day
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
Placebo
n=92 Participants
placebo, identical 45mg pill
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
Total
n=185 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 14.1 • n=99 Participants
|
51.5 years
STANDARD_DEVIATION 14.6 • n=107 Participants
|
52.2 years
STANDARD_DEVIATION 14.3 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
91 Participants
n=99 Participants
|
86 Participants
n=107 Participants
|
177 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 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
|
16 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=99 Participants
|
56 Participants
n=107 Participants
|
124 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Baseline Characteristics
|
93 Participants
n=99 Participants
|
92 Participants
n=107 Participants
|
185 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Change between baseline and 14 weeksThe primary outcome is change in heavy drinking days per week as measured by the Timeline Follow-back. A heavy drinking day is defined as : \>4 standard drinks in a day for men and \>3 standard drinks in a day for women
Outcome measures
| Measure |
Pioglitazone
n=93 Participants
Pioglitazone titrated to 45mg by mouth each day
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
Placebo
n=92 Participants
placebo, identical 45mg pill
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
|---|---|---|
|
Heavy Drinking Days Per Week Change
|
-1.76 Mean heavy drinking days per week
Interval -2.37 to -1.14
|
-2.3 Mean heavy drinking days per week
Interval -2.94 to -1.66
|
SECONDARY outcome
Timeframe: heavy drinking between week 7 and 14Population: The population of participants who were still in the study from weeks 7 through 14 were included in the analysis
The rate of no heavy drinking over the last 8 weeks of the study (weeks 6-14) is a responder analysis measure. This is the total count of participants of each group experiencing no heavy drinking days during weeks 7-14
Outcome measures
| Measure |
Pioglitazone
n=83 Participants
Pioglitazone titrated to 45mg by mouth each day
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
Placebo
n=75 Participants
placebo, identical 45mg pill
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
|---|---|---|
|
Number of Subjects With no Heavy Drinking for the Last 8 Weeks of the Study
|
51 Participants
|
49 Participants
|
SECONDARY outcome
Timeframe: Change in mean drinks per week from baseline to week 14Mean number of standard drinks per week as measured by the Timeline Follow-back
Outcome measures
| Measure |
Pioglitazone
n=93 Participants
Pioglitazone titrated to 45mg by mouth each day
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
Placebo
n=92 Participants
placebo, identical 45mg pill
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
|---|---|---|
|
Number of Drinks Per Week
|
-20.15 Change in mean drinks per week
Interval -27.3 to -13.0
|
-21.20 Change in mean drinks per week
Interval -28.6 to -13.8
|
SECONDARY outcome
Timeframe: Change in mean obsessive compulsive drinking scale score from baseline to week 14Craving will be measured by the Obsessive Compulsive Drinking Scale (OCDS). Range is 0-56, greater scores indicates greater craving.
Outcome measures
| Measure |
Pioglitazone
n=93 Participants
Pioglitazone titrated to 45mg by mouth each day
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
Placebo
n=92 Participants
placebo, identical 45mg pill
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
|---|---|---|
|
Alcohol Craving
|
-5.30 Total OCDS score
Interval -6.37 to -1.63
|
-4.0 Total OCDS score
Interval -7.76 to -2.84
|
SECONDARY outcome
Timeframe: Change between baseline and 14 weeksEtG and EtS are direct metabolites of alcohol and remains in urine for up to 5 days after cessation from alcohol and they are highly sensitive with good specificity for alcohol use. ETG and ETS results are dichotomous and scored as either positive or negative for alcohol.
Outcome measures
| Measure |
Pioglitazone
n=93 Participants
Pioglitazone titrated to 45mg by mouth each day
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
Placebo
n=92 Participants
placebo, identical 45mg pill
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
|---|---|---|
|
Ethyl Glucuronide (EtG) and Ethyl Sulfate (EtS) Positivity
|
0.00 change in ETG/ETS positive tests
Interval -0.178 to 0.178
|
-0.03 change in ETG/ETS positive tests
Interval -0.219 to 0.154
|
Adverse Events
Pioglitazone
Serious events: 5 serious events
Other events: 76 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 76 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pioglitazone
n=93 participants at risk
Pioglitazone titrated to 45mg by mouth each day
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
Placebo
n=92 participants at risk
placebo, identical 45mg pill
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
|---|---|---|
|
Psychiatric disorders
Alcohol intoxication
|
3.2%
3/93 • Number of events 9 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
4.3%
4/92 • Number of events 4 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
1/93 • Number of events 1 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
1.1%
1/92 • Number of events 1 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
|
Cardiac disorders
chest pain
|
1.1%
1/93 • Number of events 1 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
0.00%
0/92 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
|
Gastrointestinal disorders
gastrointestinal bleed
|
0.00%
0/93 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
1.1%
1/92 • Number of events 1 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
Other adverse events
| Measure |
Pioglitazone
n=93 participants at risk
Pioglitazone titrated to 45mg by mouth each day
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
Placebo
n=92 participants at risk
placebo, identical 45mg pill
Brief Behavioral Compliance Enhancement Treatment: This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
|
|---|---|---|
|
Blood and lymphatic system disorders
Edema
|
25.8%
24/93 • Number of events 68 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
22.8%
21/92 • Number of events 48 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
|
General disorders
Weight gain
|
31.2%
29/93 • Number of events 42 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
19.6%
18/92 • Number of events 34 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
53.8%
50/93 • Number of events 114 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
39.1%
36/92 • Number of events 80 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
47.3%
44/93 • Number of events 96 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
42.4%
39/92 • Number of events 101 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
34.4%
32/93 • Number of events 80 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
34.8%
32/92 • Number of events 67 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
|
General disorders
Fatigue
|
51.6%
48/93 • Number of events 100 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
50.0%
46/92 • Number of events 99 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
31.2%
29/93 • Number of events 48 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
20.7%
19/92 • Number of events 29 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
|
Eye disorders
Blurred vision
|
31.2%
29/93 • Number of events 64 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
32.6%
30/92 • Number of events 53 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
|
Gastrointestinal disorders
Nausea
|
7.5%
7/93 • Number of events 7 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
9.8%
9/92 • Number of events 9 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
|
General disorders
Headache
|
7.5%
7/93 • Number of events 8 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
5.4%
5/92 • Number of events 8 • 14 weeks (baseline to week 14)
Adverse events were gathered from a checklist developed for the study based on adverse events from pioglitazone package insert. Subjects may be affected by more than one adverse event.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place