Trial Outcomes & Findings for Naltrexone for Individuals of East Asian Descent (NCT NCT02026011)

NCT ID: NCT02026011

Last Updated: 2019-07-17

Results Overview

Alcohol Urge Questionnaire (AUQ) is used to assess subjective experiences of craving for alcohol. It consists of 8 items, each rated on a 7-point Likert scale (1 = strongly disagree, 7 = strongly agree). A summary score is used at each assessment time point. The AUQ was administered at baseline and three levels of breath alcohol concentration: 0.02 g/dl. 0.04, g/dl, and 0.06 g/dl.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

87 participants

Primary outcome timeframe

The AUQ was administered across a period of approximately 1.5 hours.

Results posted on

2019-07-17

Participant Flow

A total of 199 individuals were screened in the laboratory, of those 106 completed the physical exam, and of those 87 were eligible and agreed to be randomized. Participants received in random order either Naltrexone (titrated up to 50 mg/day) or Placebo at each Allocation.

Participant milestones

Participant milestones
Measure	Allocated to Naltrexone Group that was randomly assigned to receive Naltrexone first.	Allocated to Placebo Group that was randomly assigned to receive Placebo first
Allocation 1 (First Set of Medication) STARTED	46	41
Allocation 1 (First Set of Medication) COMPLETED	38	39
Allocation 1 (First Set of Medication) NOT COMPLETED	8	2
Allocation 2 (Second Set of Medication) STARTED	38	37
Allocation 2 (Second Set of Medication) COMPLETED	37	35
Allocation 2 (Second Set of Medication) NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Allocated to Naltrexone Group that was randomly assigned to receive Naltrexone first.	Allocated to Placebo Group that was randomly assigned to receive Placebo first
Allocation 1 (First Set of Medication) Side Effects	6	0
Allocation 1 (First Set of Medication) Withdrawal by Subject	1	2
Allocation 1 (First Set of Medication) Investigator Withdrawal	1	0
Allocation 2 (Second Set of Medication) Withdrawal by Subject	1	2

Baseline Characteristics

Naltrexone for Individuals of East Asian Descent

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Asn40Asn Genotype n=29 Participants Group that is homozygotes for the Asn40 allele	Asn40asp/Asp40Asp Genotype n=48 Participants Group that is a carrier of the Asp40 allele	Total n=77 Participants Total of all reporting groups
Age, Continuous	28.72 years STANDARD_DEVIATION 7.57 • n=5 Participants	25.69 years STANDARD_DEVIATION 4.84 • n=7 Participants	26.83 years STANDARD_DEVIATION 6.15 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	19 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	29 Participants n=7 Participants	49 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Chinese	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Japanese	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Korean	11 Participants n=5 Participants	24 Participants n=7 Participants	35 Participants n=5 Participants
Race/Ethnicity, Customized Ethnicity · Taiwanese	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Region of Enrollment United States	29 Participants n=5 Participants	48 Participants n=7 Participants	77 Participants n=5 Participants
Alcohol Use Disorder Identification Test (AUDIT)	16.14 units on a scale STANDARD_DEVIATION 5.82 • n=5 Participants	13.17 units on a scale STANDARD_DEVIATION 4.83 • n=7 Participants	14.29 units on a scale STANDARD_DEVIATION 5.39 • n=5 Participants

PRIMARY outcome

Timeframe: The AUQ was administered across a period of approximately 1.5 hours.

Population: Participants who completed at least one experimental session.

Outcome measures

Outcome measures
Measure	Naltrexone - Asn40Asn n=27 Participants Group that was randomized to receive Naltrexone (50 mg/d) and is homozygote for the Asn40 allele.	Naltrexone - Asn40Asp/Asp40Asp n=48 Participants Group that was randomized to receive Naltrexone (50mg/d) and carries at least one copy of the Asp40 allele.	Placebo - Asn40Asn n=28 Participants The group that was randomized to receive placebo and is homozygote for the Asn40 allele.	Placebo - Asn40Asp/Asp40Asp n=46 Participants Group that was randomized to receive Placebo and carries at least one copy of the Asp40 allele.
Subjective Response - Craving for Alcohol BrAC = 0.02 g/dl	1.7037 score on a scale Standard Deviation 0.9295	1.9965 score on a scale Standard Deviation 1.2862	2.1012 score on a scale Standard Deviation 1.2881	1.8478 score on a scale Standard Deviation 0.9812
Subjective Response - Craving for Alcohol BrAc = 0.06 g/dl	2.0185 score on a scale Standard Deviation 1.3590	2.2014 score on a scale Standard Deviation 1.3430	2.3095 score on a scale Standard Deviation 1.4400	2.4891 score on a scale Standard Deviation 1.4595
Subjective Response - Craving for Alcohol BrAC = 0.04 g/dl	1.9198 score on a scale Standard Deviation 1.1260	2.1319 score on a scale Standard Deviation 1.3024	2.3095 score on a scale Standard Deviation 1.4499	2.2645 score on a scale Standard Deviation 1.2311

PRIMARY outcome

Timeframe: The BAES Stimulant Subscale was administered at baseline and three levels of breath alcohol concentration: 0.2 g/dl. 0.04, g/dl, and 0.06 g/dl taking place within approximately 1.5 hours

Population: Participants who completed at least one experimental session.

The Biphasic Alcohol Effects Scale (BAES) Stimulant Subscale consists of 14 items designed to capture the stimulant effects of alcohol, rated on an 11-point scale (0 = not at all. 10 = extremely). Total score for the stimulant subscale ranges from 0-70.

Outcome measures

Outcome measures
Measure	Naltrexone - Asn40Asn n=27 Participants Group that was randomized to receive Naltrexone (50 mg/d) and is homozygote for the Asn40 allele.	Naltrexone - Asn40Asp/Asp40Asp n=48 Participants Group that was randomized to receive Naltrexone (50mg/d) and carries at least one copy of the Asp40 allele.	Placebo - Asn40Asn n=28 Participants The group that was randomized to receive placebo and is homozygote for the Asn40 allele.	Placebo - Asn40Asp/Asp40Asp n=46 Participants Group that was randomized to receive Placebo and carries at least one copy of the Asp40 allele.
Subjective Response - Stimulation BrAc = 0.06 g/dl	2.8307 score on a scale Standard Deviation 2.3581	3.0149 score on a scale Standard Deviation 2.1955	2.2347 score on a scale Standard Deviation 1.9917	3.0466 score on a scale Standard Deviation 2.4146
Subjective Response - Stimulation BrAC = 0.02 g/dl	2.0423 score on a scale Standard Deviation 1.7338	2.0893 score on a scale Standard Deviation 1.8291	2.0102 score on a scale Standard Deviation 1.9867	1.8106 score on a scale Standard Deviation 1.7512
Subjective Response - Stimulation BrAC = 0.04 g/dl	2.2963 score on a scale Standard Deviation 1.8860	2.7679 score on a scale Standard Deviation 1.9415	2.3316 score on a scale Standard Deviation 2.0949	2.4658 score on a scale Standard Deviation 1.9971

PRIMARY outcome

Timeframe: The BAES Sedation Subscale was administered at baseline and three levels of breath alcohol concentration: 0.2 g/dl. 0.04, g/dl, and 0.06 g/dl taking place within approximately 1.5 hours

Population: Participants who completed at least one experimental session.

The Biphasic Alcohol Effects Scale (BAES) Sedation Subscale consists of 14 items designed to capture the sedating effects of alcohol, rated on an 11-point scale (0 = not at all. 10 = extremely). Total score for the sedation subscale ranges from 0-70.

Outcome measures

Outcome measures
Measure	Naltrexone - Asn40Asn n=27 Participants Group that was randomized to receive Naltrexone (50 mg/d) and is homozygote for the Asn40 allele.	Naltrexone - Asn40Asp/Asp40Asp n=48 Participants Group that was randomized to receive Naltrexone (50mg/d) and carries at least one copy of the Asp40 allele.	Placebo - Asn40Asn n=28 Participants The group that was randomized to receive placebo and is homozygote for the Asn40 allele.	Placebo - Asn40Asp/Asp40Asp n=46 Participants Group that was randomized to receive Placebo and carries at least one copy of the Asp40 allele.
Subjective Response - Sedation BrAC = 0.02 g/dl	2.6825 score on a scale Standard Deviation 2.1146	2.3482 score on a scale Standard Deviation 1.6194	2.1480 score on a scale Standard Deviation 1.6452	2.0560 score on a scale Standard Deviation 1.6726
Subjective Response - Sedation BrAC = 0.04 g/dl	2.8571 score on a scale Standard Deviation 2.1907	2.8601 score on a scale Standard Deviation 2.0094	2.4949 score on a scale Standard Deviation 1.7798	2.6832 score on a scale Standard Deviation 1.8504
Subjective Response - Sedation BrAc = 0.06 g/dl	3.0688 score on a scale Standard Deviation 2.4364	3.1548 score on a scale Standard Deviation 2.0981	2.6786 score on a scale Standard Deviation 2.4767	2.4627 score on a scale Standard Deviation 1.8025

PRIMARY outcome

Timeframe: During the alcohol cue exposure fMRI paradigm which is expected to last 45 minutes

Population: Participants who completed at least one experimental session and whose neuroimaging data was not excluded due to excessive motion (\>2 mm translation) and/or poor registration.

Alcohol taste cues task for functional magnetic resonance imaging (fMRI). Region of Interest (ROI) were atomically defined using the Harvard-Oxford atlas in standard Montreal Neurological Institute (MNI) space, which were transformed into individual participants' native space using Functional Magnetic Resonance Imaging of the Brain Software Library (FSL). Contrast estimates are for Alc \> Water cue, and are arbitrary units.

Outcome measures

Outcome measures
Measure	Naltrexone - Asn40Asn n=18 Participants Group that was randomized to receive Naltrexone (50 mg/d) and is homozygote for the Asn40 allele.	Naltrexone - Asn40Asp/Asp40Asp n=23 Participants Group that was randomized to receive Naltrexone (50mg/d) and carries at least one copy of the Asp40 allele.	Placebo - Asn40Asn n=18 Participants The group that was randomized to receive placebo and is homozygote for the Asn40 allele.	Placebo - Asn40Asp/Asp40Asp n=23 Participants Group that was randomized to receive Placebo and carries at least one copy of the Asp40 allele.
Neural Response to Alcohol Cues Ventral Striatum	1.48 Mean contrast estimate for Alc>Water cue Standard Deviation 19.94	8.07 Mean contrast estimate for Alc>Water cue Standard Deviation 13.95	.53 Mean contrast estimate for Alc>Water cue Standard Deviation 13.47	1.03 Mean contrast estimate for Alc>Water cue Standard Deviation 13.54
Neural Response to Alcohol Cues Orbitofrontal cortex	.12 Mean contrast estimate for Alc>Water cue Standard Deviation 11.75	4.43 Mean contrast estimate for Alc>Water cue Standard Deviation 9.64	.45 Mean contrast estimate for Alc>Water cue Standard Deviation 7.2	3.56 Mean contrast estimate for Alc>Water cue Standard Deviation 6.95
Neural Response to Alcohol Cues Anterior Cingulate cortex	3.31 Mean contrast estimate for Alc>Water cue Standard Deviation 17.96	7.04 Mean contrast estimate for Alc>Water cue Standard Deviation 13.90	5.17 Mean contrast estimate for Alc>Water cue Standard Deviation 14.24	9.49 Mean contrast estimate for Alc>Water cue Standard Deviation 13.07

SECONDARY outcome

Timeframe: Alcohol self-administration period was 1 hour long

Population: Participants who completed at least one experimental session.

Total number of drinks consumed during the alcohol self-administration task

Outcome measures

Outcome measures
Measure	Naltrexone - Asn40Asn n=27 Participants Group that was randomized to receive Naltrexone (50 mg/d) and is homozygote for the Asn40 allele.	Naltrexone - Asn40Asp/Asp40Asp n=48 Participants Group that was randomized to receive Naltrexone (50mg/d) and carries at least one copy of the Asp40 allele.	Placebo - Asn40Asn n=28 Participants The group that was randomized to receive placebo and is homozygote for the Asn40 allele.	Placebo - Asn40Asp/Asp40Asp n=46 Participants Group that was randomized to receive Placebo and carries at least one copy of the Asp40 allele.
Alcohol Self-administration - Number of Drinks	1.4444 drinks consumed Standard Deviation 1.5275	0.6458 drinks consumed Standard Deviation 1.1576	1.5714 drinks consumed Standard Deviation 1.4764	0.9565 drinks consumed Standard Deviation 1.3656

Adverse Events

Naltrexone

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Sugar Pill

Serious events: 0 serious events

Other events: 22 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Lara Ray

University of California, Los Angeles

Phone: 310-794-5383

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Other adverse events
Measure	Naltrexone n=75 participants at risk Naltrexone 50 mg/day Naltrexone: Naltrexone is an opioid receptor antagonist with highest affinity for mu opioid receptors	Sugar Pill n=74 participants at risk Matched placebo Placebo: Sugar pill, matched to the active study medication in capsule size and color
Gastrointestinal disorders Abdominal pain or cramps	6.7% 5/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	5.4% 4/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
Eye disorders Yellow Eyes	0.00% 0/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	0.00% 0/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
Gastrointestinal disorders Nausea or vomiting	10.7% 8/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	2.7% 2/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Irritability or anger	9.3% 7/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	0.00% 0/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Increased desire for sex	5.3% 4/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	4.1% 3/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Nervousness	6.7% 5/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	4.1% 3/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Ringing in the ears	2.7% 2/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	1.4% 1/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Decrease in appetite	14.7% 11/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	2.7% 2/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Depression	2.7% 2/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	1.4% 1/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Fatigue	24.0% 18/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	10.8% 8/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Difficulty in staying awake	13.3% 10/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	5.4% 4/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Increase in appetite	4.0% 3/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	4.1% 3/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
Eye disorders Blurred vision	4.0% 3/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	0.00% 0/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Drowsiness	20.0% 15/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	6.8% 5/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Headache	5.3% 4/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	5.4% 4/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Night sweats	1.3% 1/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	2.7% 2/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Mental confusion	4.0% 3/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	1.4% 1/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Anxiety	9.3% 7/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	4.1% 3/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Joint or muscle pain	2.7% 2/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	1.4% 1/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Dizziness	4.0% 3/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	1.4% 1/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Sexual problems	1.3% 1/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	0.00% 0/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Difficulty sleeping	10.7% 8/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	8.1% 6/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Fever or chills	1.3% 1/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	1.4% 1/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"
General disorders Decreased desire for sex	2.7% 2/75 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"	0.00% 0/74 • Adverse event data were collected immediately prior to alcohol infusion while on naltrexone and while on placebo (2 time points). This data was collected twice for each participant, once while they were on placebo and once while they were on naltrexone. Adverse events are defined as any symptom endorsed on the Side Effects Checklist (SAFTEE). The instructions on the SAFTEE are, "Have you noticed any of the following symptoms within the last 6 hours? If yes, how severe were the symptoms? Do you believe these symptoms were caused by the study medication?"