Trial Outcomes & Findings for Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism in Anxious Alcoholics^ (NCT NCT01227980)

NCT ID: NCT01227980

Last Updated: 2016-02-02

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: 70 participants
• Primary outcome timeframe: 15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 of the treatment period
• Results posted on: 2016-02-02

Participant Flow

Participant milestones

Measure	Pexacerfont Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days	Placebo Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Overall Study STARTED	40	30
Overall Study Scripts Challenge Sessions	26	25
Overall Study Measure Drug Level Concentration	10	0
Overall Study COMPLETED	38	25
Overall Study NOT COMPLETED	2	5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Corticotropin-Releasing Hormone Receptor 1 (CRH1) Antagonism in Anxious Alcoholics^

Baseline characteristics by cohort

Measure	Pexacerfont n=40 Participants Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days	Placebo n=30 Participants Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days	Total n=70 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	40 Participants n=5 Participants	30 Participants n=7 Participants	70 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	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Male	34 Participants n=5 Participants	25 Participants n=7 Participants	59 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	38 Participants n=5 Participants	30 Participants n=7 Participants	68 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	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants	9 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: 15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 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	Pexacerfont n=26 Participants Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days	Placebo n=25 Participants Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Alcohol Craving in Response to the Alcohol Cue Script	12.7 Units on a scale Standard Error 2.48	10.7 Units on a scale Standard Error 2.60

PRIMARY outcome

Timeframe: 5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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	Pexacerfont n=26 Participants Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days	Placebo n=25 Participants Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Alcohol Craving in Response to the Alcohol Cue Script	18.7 units on a scale Standard Error 2.48	14.5 units on a scale Standard Error 2.6

PRIMARY outcome

Timeframe: 15 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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	Pexacerfont n=26 Participants Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days	Placebo n=25 Participants Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Alcohol Craving in Response to the Alcohol Cue Script	16.6 Units on a scale Standard Error 2.48	12.9 Units on a scale Standard Error 2.6

PRIMARY outcome

Timeframe: 30 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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	Pexacerfont n=26 Participants Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days	Placebo n=25 Participants Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Alcohol Craving in Response to the Alcohol Cue Script	16.5 units on a scale Standard Error 2.48	11.8 units on a scale Standard Error 2.6

PRIMARY outcome

Timeframe: 45 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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	Pexacerfont n=26 Participants Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days	Placebo n=25 Participants Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Alcohol Craving in Response to the Alcohol Cue Script	15 units on a scale Standard Error 2.48	12.1 units on a scale Standard Error 2.6

PRIMARY outcome

Timeframe: 60 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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	Pexacerfont n=26 Participants Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days	Placebo n=25 Participants Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Alcohol Craving in Response to the Alcohol Cue Script	13.7 units on a scale Standard Error 2.48	12.3 units on a scale Standard Error 2.6

PRIMARY outcome

Timeframe: 75 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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	Pexacerfont n=26 Participants Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days	Placebo n=25 Participants Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Alcohol Craving in Response to the Alcohol Cue Script	13.5 units on a scale Standard Error 2.48	12 units on a scale Standard Error 2.6

PRIMARY outcome

Timeframe: 90 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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	Pexacerfont n=26 Participants Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days	Placebo n=25 Participants Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Alcohol Craving in Response to the Alcohol Cue Script	13.7 units on a scale Standard Error 2.48	11.7 units on a scale Standard Error 2.6

PRIMARY outcome

Timeframe: 15 minutes prior to the beginning of script presentation, which occurred on Day 24, 25, or 26 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	Pexacerfont n=26 Participants Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days	Placebo n=25 Participants Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Alcohol Craving in Response to the Stress Script	12.9 units on a scale Standard Error 2.61	10.2 units on a scale Standard Error 2.74

PRIMARY outcome

Timeframe: 5 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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	Pexacerfont n=26 Participants Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days	Placebo n=25 Participants Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Alcohol Craving in Response to the Stress Script	17.8 units on a scale Standard Error 2.61	14.4 units on a scale Standard Error 2.74

PRIMARY outcome

Timeframe: 15 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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	Pexacerfont n=26 Participants Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days	Placebo n=25 Participants Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Alcohol Craving in Response to the Stress Script	16.8 units on a scale Standard Error 2.61	12.5 units on a scale Standard Error 2.74

PRIMARY outcome

Timeframe: 30 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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	Pexacerfont n=26 Participants Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days	Placebo n=25 Participants Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Alcohol Craving in Response to the Stress Script	15.3 units on a scale Standard Error 2.61	12.2 units on a scale Standard Error 2.74

PRIMARY outcome

Timeframe: 45 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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	Pexacerfont n=26 Participants Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days	Placebo n=25 Participants Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Alcohol Craving in Response to the Stress Script	14.9 units on a scale Standard Error 2.61	11.6 units on a scale Standard Error 2.74

PRIMARY outcome

Timeframe: 60 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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	Pexacerfont n=26 Participants Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days	Placebo n=25 Participants Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Alcohol Craving in Response to the Stress Script	14.3 units on a scale Standard Error 2.61	11.6 units on a scale Standard Error 2.74

PRIMARY outcome

Timeframe: 75 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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	Pexacerfont n=26 Participants Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days	Placebo n=25 Participants Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Alcohol Craving in Response to the Stress Script	14.9 units on a scale Standard Error 2.61	11.7 units on a scale Standard Error 2.74

PRIMARY outcome

Timeframe: 90 minutes after the beginning of script presentation, which occurred on Day 24, 25, or 26 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	Pexacerfont n=26 Participants Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days	Placebo n=25 Participants Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Alcohol Craving in Response to the Stress Script	14.6 Units on a scale Standard Error 2.61	11.2 Units on a scale Standard Error 2.74

Adverse Events

Pexacerfont

Serious events: 0 serious events

Other events: 34 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 28 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Pexacerfont n=40 participants at risk Pexacerfont was given orally as a loading dose of 300 mg/day for 1 week, followed by 100mg/day for 16-20 days	Placebo n=30 participants at risk Oral placebo was given during the 1-week loading dose phase, and during the next 16-20 days
Gastrointestinal disorders Abdominal pain	5.0% 2/40 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge	0.00% 0/30 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge
Gastrointestinal disorders Nausea	22.5% 9/40 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge	36.7% 11/30 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge
Gastrointestinal disorders Toothache	0.00% 0/40 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge	6.7% 2/30 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge
Gastrointestinal disorders Vomiting	7.5% 3/40 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge	6.7% 2/30 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge
General disorders Fatigue	72.5% 29/40 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge	80.0% 24/30 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/40 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge	10.0% 3/30 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge
Musculoskeletal and connective tissue disorders Pain in extremity	5.0% 2/40 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge	10.0% 3/30 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge
Nervous system disorders Dizziness	17.5% 7/40 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge	20.0% 6/30 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge
Nervous system disorders Headache	57.5% 23/40 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge	76.7% 23/30 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge
Nervous system disorders Memory impairment	0.00% 0/40 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge	6.7% 2/30 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/40 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge	6.7% 2/30 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge
Psychiatric disorders Anxiety	5.0% 2/40 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge	10.0% 3/30 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge
Psychiatric disorders Insomnia	5.0% 2/40 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge	0.00% 0/30 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.0% 2/40 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge	0.00% 0/30 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge
Respiratory, thoracic and mediastinal disorders Sore throat	25.0% 10/40 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge	26.7% 8/30 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	0.00% 0/40 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge	10.0% 3/30 • Adverse event data were collected biweekly throughout the 27 day inpatient stay, and at two follow-up outpatient visits at 1 and 4 weeks following discharge

Additional Information

Melanie Schwandt

National Institute on Alcohol Abuse and Alcoholism

Phone: 301-451-6960

Email: melanies@mail.nih.gov

Results disclosure agreements

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