Trial Outcomes & Findings for The Effect of NK1R Antagonism on Alcohol Craving and PTSD Symptoms in Alcohol Dependent Patients With PTSD (NCT NCT00896038)

NCT ID: NCT00896038

Last Updated: 2015-11-03

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: COMPLETED
• Study phase: PHASE2
• Target enrollment: 58 participants
• Primary outcome timeframe: 15 minutes prior to the beginning of stress script presentation, which occurred on Day 25, 26, or 27 of the treatment period
• Results posted on: 2015-11-03

Participant Flow

Participant milestones

Measure	Placebo Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days	Aprepitant Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days
Overall Study STARTED	28	30
Overall Study COMPLETED	27	26
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of NK1R Antagonism on Alcohol Craving and PTSD Symptoms in Alcohol Dependent Patients With PTSD

Baseline characteristics by cohort

Measure	Aprepitant n=30 Participants Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days	Placebo n=28 Participants Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days	Total n=58 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	28 Participants n=7 Participants	58 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	30 Participants n=5 Participants	26 Participants n=7 Participants	56 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	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	12 Participants n=7 Participants	28 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	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes prior to the beginning of stress script presentation, which occurred on Day 25, 26, or 27 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	Aprepitant n=26 Participants Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days	Placebo n=24 Participants Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
Alcohol Craving in Response to the Stress Script	11.9 units on a scale Standard Error 2.29	12.9 units on a scale Standard Error 2.39

PRIMARY outcome

Timeframe: 5 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 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	Aprepitant n=26 Participants Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days	Placebo n=24 Participants Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
Alcohol Craving in Response to the Stress Script	20.9 units on a scale Standard Error 2.29	25.0 units on a scale Standard Error 2.38

PRIMARY outcome

Timeframe: 15 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 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	Aprepitant n=26 Participants Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days	Placebo n=24 Participants Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
Alcohol Craving in Response to the Stress Script	19.2 units on a scale Standard Error 2.28	21.7 units on a scale Standard Error 2.39

PRIMARY outcome

Timeframe: 30 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 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	Aprepitant n=26 Participants Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days	Placebo n=24 Participants Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
Alcohol Craving in Response to the Stress Script	18.0 units on a scale Standard Error 2.28	18.0 units on a scale Standard Error 2.39

PRIMARY outcome

Timeframe: 45 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 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	Aprepitant n=26 Participants Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days	Placebo n=24 Participants Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
Alcohol Craving in Response to the Stress Script	18.1 units on a scale Standard Error 2.28	18.3 units on a scale Standard Error 2.38

PRIMARY outcome

Timeframe: 60 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 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	Aprepitant n=26 Participants Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days	Placebo n=24 Participants Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
Alcohol Craving in Response to the Stress Script	15.9 units on a scale Standard Error 2.28	17.0 units on a scale Standard Error 2.38

PRIMARY outcome

Timeframe: 75 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 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	Aprepitant n=26 Participants Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days	Placebo n=24 Participants Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
Alcohol Craving in Response to the Stress Script	15.9 units on a scale Standard Error 2.28	16.8 units on a scale Standard Error 2.38

PRIMARY outcome

Timeframe: 90 minutes after the beginning of stress script presentation, which occurred on Day 25, 26, or 27 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	Aprepitant n=26 Participants Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days	Placebo n=24 Participants Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
Alcohol Craving in Response to the Stress Script	15.9 units on a scale Standard Error 2.28	14.1 units on a scale Standard Error 2.38

PRIMARY outcome

Timeframe: 15 minutes prior to the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 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	Aprepitant n=26 Participants Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days	Placebo n=24 Participants Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
Alcohol Craving in Response to the Alcohol Cue Script	13.8 units on a scale Standard Error 2.05	14.0 units on a scale Standard Error 2.14

PRIMARY outcome

Timeframe: 5 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 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	Aprepitant n=26 Participants Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days	Placebo n=24 Participants Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
Alcohol Craving in Response to the Alcohol Cue Script	19.7 units on a scale Standard Error 2.05	20.7 units on a scale Standard Error 2.15

PRIMARY outcome

Timeframe: 15 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 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	Aprepitant n=26 Participants Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days	Placebo n=24 Participants Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
Alcohol Craving in Response to the Alcohol Cue Script	16.7 units on a scale Standard Error 2.05	16.3 units on a scale Standard Error 2.14

PRIMARY outcome

Timeframe: 30 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 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	Aprepitant n=26 Participants Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days	Placebo n=24 Participants Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
Alcohol Craving in Response to the Alcohol Cue Script	16.5 units on a scale Standard Error 2.05	14.4 units on a scale Standard Error 2.14

PRIMARY outcome

Timeframe: 45 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 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	Aprepitant n=26 Participants Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days	Placebo n=24 Participants Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
Alcohol Craving in Response to the Alcohol Cue Script	14.7 units on a scale Standard Error 2.05	15.1 units on a scale Standard Error 2.14

PRIMARY outcome

Timeframe: 60 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 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	Aprepitant n=26 Participants Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days	Placebo n=24 Participants Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
Alcohol Craving in Response to the Alcohol Cue Script	14.3 units on a scale Standard Error 2.05	14.4 units on a scale Standard Error 2.14

PRIMARY outcome

Timeframe: 75 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 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	Aprepitant n=26 Participants Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days	Placebo n=24 Participants Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
Alcohol Craving in Response to the Alcohol Cue Script	15.6 units on a scale Standard Error 2.05	13.6 units on a scale Standard Error 2.14

PRIMARY outcome

Timeframe: 90 minutes after the beginning of alcohol script presentation, which occurred on Day 25, 26, or 27 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	Aprepitant n=26 Participants Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days	Placebo n=24 Participants Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
Alcohol Craving in Response to the Alcohol Cue Script	14.8 units on a scale Standard Error 2.05	13.6 units on a scale Standard Error 2.14

PRIMARY outcome

Timeframe: Day 29 of the treatment period, 2 days after the final script presentation

Population: The analysis included subjects who completed the CAPS at both baseline (Day 1) and Day 29, and who had data for the baseline covariates used in the analysis

PTSD total symptom severity was measured using the Clinician-Administered PTSD Scale (CAPS). This is a 30-item interview-based questionnaire that measures symptom severity during the past week. The total symptom severity score ranges from 0 (lowest symptom severity) to 136 (highest symptom severity).

Outcome measures

Measure	Aprepitant n=23 Participants Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days	Placebo n=24 Participants Subjects received oral placebo during the 1-week placebo lead-in and then daily for 21 days
PTSD Total Symptom Severity Score	53.0 units on a scale Standard Error 4.79	54.2 units on a scale Standard Error 4.66

Adverse Events

Aprepitant

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Aprepitant n=30 participants at risk Following a 1-week placebo lead-in period subjects were given 125 mg of Aprepitant daily for 21 days	Placebo n=28 participants at risk Subjects received placebo during the 1-week placebo lead-in and then daily for 21 days
Gastrointestinal disorders Constipation	46.7% 14/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	28.6% 8/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Gastrointestinal disorders Diarrhea	23.3% 7/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	21.4% 6/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Gastrointestinal disorders DryMouth	23.3% 7/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	17.9% 5/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Gastrointestinal disorders Flatulence	20.0% 6/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	21.4% 6/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Gastrointestinal disorders Nausea	30.0% 9/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	39.3% 11/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Gastrointestinal disorders Stomach or AbdominalAching	43.3% 13/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	32.1% 9/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
General disorders Fatigue or Weakness	60.0% 18/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	46.4% 13/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
General disorders Irritability	40.0% 12/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	53.6% 15/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
General disorders Nightmares	6.7% 2/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	3.6% 1/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
General disorders Sleepiness	6.7% 2/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	0.00% 0/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
General disorders Sweating	26.7% 8/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	17.9% 5/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Metabolism and nutrition disorders Lack of Appetite	6.7% 2/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	10.7% 3/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Musculoskeletal and connective tissue disorders Pain in Extremity	16.7% 5/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	7.1% 2/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	14.3% 4/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Musculoskeletal and connective tissue disorders Shoulder pain	0.00% 0/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	7.1% 2/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Nervous system disorders Dizziness	23.3% 7/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	21.4% 6/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Nervous system disorders Headaches	60.0% 18/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	64.3% 18/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Psychiatric disorders Anxiety	0.00% 0/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	14.3% 4/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Psychiatric disorders Insomnia	6.7% 2/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	7.1% 2/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Psychiatric disorders Nervousness	33.3% 10/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	32.1% 9/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Psychiatric disorders Nightmares	6.7% 2/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	3.6% 1/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Psychiatric disorders Depression	6.7% 2/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	3.6% 1/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Reproductive system and breast disorders SexualDysfunction	10.0% 3/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	3.6% 1/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Respiratory, thoracic and mediastinal disorders Hiccups	3.3% 1/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	17.9% 5/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Skin and subcutaneous tissue disorders Itching	6.7% 2/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	7.1% 2/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay
Gastrointestinal disorders Upset Stomach	30.0% 9/30 • Adverse event data were collected biweekly throughout the 32 day inpatient stay	35.7% 10/28 • Adverse event data were collected biweekly throughout the 32 day inpatient stay

Additional Information

Melanie Schwandt

National Institute on Alcohol Abuse and Alcoholism

Phone: 3014516960

Email: melanies@mail.nih.gov

Results disclosure agreements

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