Trial Outcomes & Findings for Role of Proinflammatory Signaling in Alcohol Craving (NCT NCT01631630)

NCT ID: NCT01631630

Last Updated: 2017-03-09

Results Overview

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 16 participants
• Primary outcome timeframe: 15 minutes prior to the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period
• Results posted on: 2017-03-09

Participant Flow

Participant milestones

Measure	Pioglitazone Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Overall Study STARTED	8	8
Overall Study COMPLETED	5	8
Overall Study NOT COMPLETED	3	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Role of Proinflammatory Signaling in Alcohol Craving

Baseline characteristics by cohort

Measure	Pioglitazone n=8 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days	Total n=16 Participants Total of all reporting groups
Age, Categorical LTE18	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical BTWN	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Age, Categorical GTE65	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	8 Participants n=5 Participants	8 Participants n=7 Participants	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Hawaiian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes prior to the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Alcohol Cue Script	13.7505 Units on a scale Standard Error 2.3136	8.1871 Units on a scale Standard Error 1.9853

PRIMARY outcome

Timeframe: 5 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Alcohol Cue Script	20.5838 Units on a scale Standard Error 2.3136	9.6871 Units on a scale Standard Error 1.9853

PRIMARY outcome

Timeframe: 15 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Alcohol Cue Script	17.4172 Units on a scale Standard Error 2.3136	9.8121 Units on a scale Standard Error 1.9853

PRIMARY outcome

Timeframe: 30 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Alcohol Cue Script	19.0838 Units on a scale Standard Error 2.3136	10.5621 Units on a scale Standard Error 1.9853

PRIMARY outcome

Timeframe: 45 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Alcohol Cue Script	18.0838 Units on a scale Standard Error 2.3136	8.4371 Units on a scale Standard Error 1.9853

PRIMARY outcome

Timeframe: 60 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Alcohol Cue Script	16.4172 Units on a scale Standard Error 2.3136	8.9371 Units on a scale Standard Error 1.9853

PRIMARY outcome

Timeframe: 75 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Alcohol Cue Script	15.2505 Units on a scale Standard Error 2.3136	9.6871 Units on a scale Standard Error 1.9853

PRIMARY outcome

Timeframe: 90 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Alcohol Cue Script	19.2505 Units on a scale Standard Error 2.3136	8.9371 Units on a scale Standard Error 1.9853

PRIMARY outcome

Timeframe: 15 minutes prior to the subject receiving an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period

Population: The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=5 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Lipopolysaccharide Challenge	11.1285 Units on a scale Standard Error 1.5864	10.7947 Units on a scale Standard Error 1.2432

PRIMARY outcome

Timeframe: 1 hour after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period

Population: The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=5 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Lipopolysaccharide Challenge	9.5285 Units on a scale Standard Error 1.5864	9.1697 Units on a scale Standard Error 1.2432

PRIMARY outcome

Timeframe: 2 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period

Population: The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=5 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Lipopolysaccharide Challenge	11.9285 Units on a scale Standard Error 1.5864	9.0447 Units on a scale Standard Error 1.2432

PRIMARY outcome

Timeframe: 3 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period

Population: The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=5 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Lipopolysaccharide Challenge	9.5285 Units on a scale Standard Error 1.5864	10.5447 Units on a scale Standard Error 1.2432

PRIMARY outcome

Timeframe: 4 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period

Population: The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=5 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Lipopolysaccharide Challenge	12.1285 Units on a scale Standard Error 1.5864	10.5447 Units on a scale Standard Error 1.2432

PRIMARY outcome

Timeframe: 5 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period

Population: The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=5 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Lipopolysaccharide Challenge	12.1285 Units on a scale Standard Error 1.5864	10.9197 Units on a scale Standard Error 1.2432

PRIMARY outcome

Timeframe: 6 hours after the subject received an intravenous bolus of lipopolysaccharide, which occurred on Day 25 or Day 32 of the treatment period

Population: The analyses included only those subjects who completed both the lipopolysaccharide and placebo challenge sessions

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=5 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Lipopolysaccharide Challenge	9.9285 Units on a scale Standard Error 1.5864	9.6697 Units on a scale Standard Error 1.2432

PRIMARY outcome

Timeframe: 15 minutes prior to the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Stress Script	10 Units on a scale Standard Error 1.779	11.25 Units on a scale Standard Error 1.5406

PRIMARY outcome

Timeframe: 15 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Stress Script	10 Units on a scale Standard Error 1.779	12.125 Units on a scale Standard Error 1.5406

PRIMARY outcome

Timeframe: 5 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Stress Script	10.3333 Units on a scale Standard Error 1.779	11.875 Units on a scale Standard Error 1.5406

PRIMARY outcome

Timeframe: 30 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Stress Script	10 Units on a scale Standard Error 1.779	11.375 Units on a scale Standard Error 1.5406

PRIMARY outcome

Timeframe: 45 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Stress Script	10.1667 Units on a scale Standard Error 1.779	9.125 Units on a scale Standard Error 1.5406

PRIMARY outcome

Timeframe: 60 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Stress Script	10.1667 Units on a scale Standard Error 1.779	9.25 Units on a scale Standard Error 1.5406

PRIMARY outcome

Timeframe: 75 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Stress Script	10.1667 Units on a scale Standard Error 1.779	9.5 Units on a scale Standard Error 1.5406

PRIMARY outcome

Timeframe: 90 minutes after the beginning of script presentation, which occurred on Day 21, 22, or 23 of the treatment period

Population: The analyses included only those subjects who completed all three script types (neutral, alcohol, stress)

Alcohol craving was measured using the Alcohol Urges Questionnaire (AUQ). The AUQ is an 8-item self-administered instrument that assesses craving for alcohol among alcohol users in the current context (i.e., right now). The score ranges from 8 (lowest craving value) to 56 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Alcohol Craving in Response to the Stress Script	10.6667 Units on a scale Standard Error 1.779	9.625 Units on a scale Standard Error 1.5406

SECONDARY outcome

Timeframe: Day 1 of the treatment period

Population: The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	2.8502 Units on a scale Standard Error 1.4379	4.5791 Units on a scale Standard Error 1.235

SECONDARY outcome

Timeframe: Day 3 of the treatment period

Population: The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	5.884 Units on a scale Standard Error 1.3775	0.5706 Units on a scale Standard Error 1.1885

SECONDARY outcome

Timeframe: Day 7 of the treatment period

Population: The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	3.2897 Units on a scale Standard Error 1.4413	2.0706 Units on a scale Standard Error 1.1885

SECONDARY outcome

Timeframe: Day 10 of the treatment period

Population: The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	3.3403 Units on a scale Standard Error 1.4413	1.1956 Units on a scale Standard Error 1.1885

SECONDARY outcome

Timeframe: Day 14 of the treatment period

Population: The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	4.2173 Units on a scale Standard Error 1.3775	1.2136 Units on a scale Standard Error 1.2176

SECONDARY outcome

Timeframe: Day 17 of the treatment period

Population: The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	5.0507 Units on a scale Standard Error 1.3775	1.0706 Units on a scale Standard Error 1.1885

SECONDARY outcome

Timeframe: Day 21 of the treatment period

Population: The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	5.0507 Units on a scale Standard Error 1.3775	1.6956 Units on a scale Standard Error 1.1885

SECONDARY outcome

Timeframe: Day 24 of the treatment period

Population: The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	3.884 Units on a scale Standard Error 1.3775	0.6956 Units on a scale Standard Error 1.1885

SECONDARY outcome

Timeframe: Day 28 of the treatment period

Population: The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	4.884 Units on a scale Standard Error 1.3775	1.1125 Units on a scale Standard Error 1.2543

SECONDARY outcome

Timeframe: Day 31 of the treatment period

Population: The analyses included only those subjects who had a baseline anxiety symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Anxiety symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Anxiety Symptom Ratings Measured Bi-weekly During the Treatment Period	7.2173 Units on a scale Standard Error 1.3775	1.8206 Units on a scale Standard Error 1.1885

SECONDARY outcome

Timeframe: Day 1 of the treatment period

Population: The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	6.3661 Units on a scale Standard Error 1.4855	3.2956 Units on a scale Standard Error 1.275

SECONDARY outcome

Timeframe: Day 3 of the treatment period

Population: The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	5.6366 Units on a scale Standard Error 1.4174	0.9937 Units on a scale Standard Error 1.2232

SECONDARY outcome

Timeframe: Day 7 of the treatment period

Population: The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	4.9065 Units on a scale Standard Error 1.4906	0.9937 Units on a scale Standard Error 1.2232

SECONDARY outcome

Timeframe: Day 10 of the treatment period

Population: The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	4.7167 Units on a scale Standard Error 1.4906	0.8687 Units on a scale Standard Error 1.2232

SECONDARY outcome

Timeframe: Day 14 of the treatment period

Population: The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	4.6366 Units on a scale Standard Error 1.4174	0.5912 Units on a scale Standard Error 1.2569

SECONDARY outcome

Timeframe: Day 17 of the treatment period

Population: The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	6.3032 Units on a scale Standard Error 1.4174	0.8687 Units on a scale Standard Error 1.2232

SECONDARY outcome

Timeframe: Day 21 of the treatment period

Population: The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	5.1366 Units on a scale Standard Error 1.4174	1.4937 Units on a scale Standard Error 1.2232

SECONDARY outcome

Timeframe: Day 24 of the treatment period

Population: The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	7.1366 Units on a scale Standard Error 1.4174	1.1187 Units on a scale Standard Error 1.2232

SECONDARY outcome

Timeframe: Day 28 of the treatment period

Population: The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	6.4699 Units on a scale Standard Error 1.4174	1.1228 Units on a scale Standard Error 1.299

SECONDARY outcome

Timeframe: Day 31 of the treatment period

Population: The analyses included only those subjects who had a baseline depression symptom rating taken 1 day after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Depression symptoms were measured using the Comprehensive Psychopathological Rating Scale (CPRS). The CPRS is an 18-item interview-based instrument for assessing depression and anxiety. There are two 10-item subscales, the Montgomery-Asberg Depression Rating Scale (MADRS) and the Brief Scale for Anxiety (BSA). Each subscale ranges from 0 (lowest symptom severity) to 60 (highest symptom severity).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Depression Symptom Ratings Measured Bi-weekly During the Treatment Period	8.6366 Units on a scale Standard Error 1.4174	0.8687 Units on a scale Standard Error 1.2232

SECONDARY outcome

Timeframe: Day 1 of the treatment period

Population: The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	7.7503 Units on a scale Standard Error 1.7317	7.8122 Units on a scale Standard Error 1.4976

SECONDARY outcome

Timeframe: Day 3 of the treatment period

Population: The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	8.417 Units on a scale Standard Error 1.7317	5.9372 Units on a scale Standard Error 1.4976

SECONDARY outcome

Timeframe: Day 7 of the treatment period

Population: The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	7.0837 Units on a scale Standard Error 1.7317	4.1872 Units on a scale Standard Error 1.4976

SECONDARY outcome

Timeframe: Day 10 of the treatment period

Population: The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	6.0837 Units on a scale Standard Error 1.7317	3.9372 Units on a scale Standard Error 1.4976

SECONDARY outcome

Timeframe: Day 14 of the treatment period

Population: The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	4.7503 Units on a scale Standard Error 1.7317	4.1872 Units on a scale Standard Error 1.4976

SECONDARY outcome

Timeframe: Day 17 of the treatment period

Population: The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	4.7503 Units on a scale Standard Error 1.7317	4.0622 Units on a scale Standard Error 1.4976

SECONDARY outcome

Timeframe: Day 21 of the treatment period

Population: The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	4.417 Units on a scale Standard Error 1.7317	3.8122 Units on a scale Standard Error 1.4976

SECONDARY outcome

Timeframe: Day 24 of the treatment period

Population: The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	5.917 Units on a scale Standard Error 1.7317	2.3122 Units on a scale Standard Error 1.4976

SECONDARY outcome

Timeframe: Day 28 of the treatment period

Population: The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	6.417 Units on a scale Standard Error 1.7317	2.6872 Units on a scale Standard Error 1.4976

SECONDARY outcome

Timeframe: Day 31 of the treatment period

Population: The analyses included only those subjects who had a baseline craving measure taken 4 days after inpatient admission (but prior to enrollment in this protocol), and who completed all 33 days of the treatment period

Alcohol craving was measured using the Penn Alcohol Craving Scale (PACS). The PACS is a five-item self-administered instrument for assessing alcohol craving over the course of the past week. The score ranges from 0 (lowest craving value) to 30 (highest craving value).

Outcome measures

Measure	Pioglitazone n=6 Participants Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 Participants Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Spontaneous Alcohol Craving Measured Bi-weekly During the Treatment Period	4.5837 Units on a scale Standard Error 1.7317	2.8122 Units on a scale Standard Error 1.4976

Adverse Events

Pioglitazone

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pioglitazone n=8 participants at risk Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 participants at risk Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Investigations Abnormal glucose	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Investigations Elevated Creatine Kinase	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject

Other adverse events

Measure	Pioglitazone n=8 participants at risk Subjects received pioglitazone, 15mg/day for 3 days; 30mg day for 3 days; 45mg/day thereafter, for a minimum total of 13 days	Placebo n=8 participants at risk Subjects received placebo on a similar dosing schedule as pioglitazone, for a minimum total of 13 days
Eye disorders Blurred vision	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Gastrointestinal disorders Bloating	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Gastrointestinal disorders Blood in stool	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Gastrointestinal disorders Nausea	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	25.0% 2/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Gastrointestinal disorders Stomach pain	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Gastrointestinal disorders Toothache	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	37.5% 3/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
General disorders Buzzed	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
General disorders Chills	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
General disorders Fatigue	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
General disorders Fever	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
General disorders Irritability	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
General disorders Loss of Appetite	25.0% 2/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
General disorders Low RBC/HGB A1C	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
General disorders Pain	25.0% 2/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
General disorders Sleepiness	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
General disorders Tiredness	62.5% 5/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	62.5% 5/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
General disorders Trouble Sleeping	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Investigations Abnormal platelet count	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Investigations Aspartate aminotransferase increased	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Investigations Elevated Creatine Kinase	50.0% 4/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Musculoskeletal and connective tissue disorders Muscle aches	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	37.5% 3/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Musculoskeletal and connective tissue disorders Muscle tightness	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Musculoskeletal and connective tissue disorders Neck pain	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Nervous system disorders Headache	25.0% 2/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	50.0% 4/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Nervous system disorders Light headed	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Nervous system disorders Sinus pain	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	25.0% 2/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Psychiatric disorders Anxiety	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Renal and urinary disorders Dark Urine	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Renal and urinary disorders Urinary frequency	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Respiratory, thoracic and mediastinal disorders Cold-like symptoms	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	37.5% 3/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Respiratory, thoracic and mediastinal disorders Sore throat	25.0% 2/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	25.0% 2/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Skin and subcutaneous tissue disorders Acne	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Skin and subcutaneous tissue disorders Itching	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject
Vascular disorders Phlebitis	0.00% 0/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject	12.5% 1/8 • Adverse event data were collected throughout the 31 days of the inpatient stay for each subject

Additional Information

Diazgranados, Nancy

National Institute on Alcohol Abuse and Alcoholism

Phone: +1 301 435 9386

Email: nancy.diazgranados@nih.gov

Results disclosure agreements

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