Trial · NCT02026011

Naltrexone for Individuals of East Asian Descent

NCT02026011, Phase 2, Completed, University of California, Los Angeles; results first posted 2019-07-17

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Naltrexone for Individuals of East Asian Descent. Trials, record NCT02026011. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02026011

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Naltrexone for Individuals of East Asian Descent
NCT number: NCT02026011
Status: Completed
Phases: Phase 2
Enrollment: 87 participants, actual
Lead sponsor: University of California, Los Angeles
Conditions: Alcohol Use Disorder
Interventions: Naltrexone, Placebo
First posted: 2014-01-01
Last updated: 2019-07-17
Results first posted: 2019-07-17

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Subjective Response - Craving for Alcohol	The AUQ was administered across a period of approximately 1.5 hours.	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.
Primary	Subjective Response - Stimulation	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	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.
Primary	Subjective Response - Sedation	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	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.
Primary	Neural Response to Alcohol Cues	During the alcohol cue exposure fMRI paradigm which is expected to last 45 minutes	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.
Secondary	Alcohol Self-administration - Number of Drinks	Alcohol self-administration period was 1 hour long	Total number of drinks consumed during the alcohol self-administration task

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Subjective Response - Craving for Alcohol	The AUQ was administered across a period of approximately 1.5 hours.	Participants who completed at least one experimental session.	score on a scale	MEAN
PRIMARY	Subjective Response - Stimulation	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	Participants who completed at least one experimental session.	score on a scale	MEAN
PRIMARY	Subjective Response - Sedation	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	Participants who completed at least one experimental session.	score on a scale	MEAN
PRIMARY	Neural Response to Alcohol Cues	During the alcohol cue exposure fMRI paradigm which is expected to last 45 minutes	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.	Mean contrast estimate for Alc>Water cue	MEAN
SECONDARY	Alcohol Self-administration - Number of Drinks	Alcohol self-administration period was 1 hour long	Participants who completed at least one experimental session.	drinks consumed	MEAN

Source ClinicalTrials.gov

Results by group52

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Subjective Response - Craving for Alcohol	Naltrexone - Asn40Asn	BrAC = 0.02 g/dl	1.7037	Standard Deviation 0.9295	score on a scale
Subjective Response - Craving for Alcohol	Naltrexone - Asn40Asp/Asp40Asp	BrAC = 0.02 g/dl	1.9965	Standard Deviation 1.2862	score on a scale
Subjective Response - Craving for Alcohol	Placebo - Asn40Asn	BrAC = 0.02 g/dl	2.1012	Standard Deviation 1.2881	score on a scale
Subjective Response - Craving for Alcohol	Placebo - Asn40Asp/Asp40Asp	BrAC = 0.02 g/dl	1.8478	Standard Deviation 0.9812	score on a scale
Subjective Response - Craving for Alcohol	Naltrexone - Asn40Asn	BrAC = 0.04 g/dl	1.9198	Standard Deviation 1.1260	score on a scale
Subjective Response - Craving for Alcohol	Naltrexone - Asn40Asp/Asp40Asp	BrAC = 0.04 g/dl	2.1319	Standard Deviation 1.3024	score on a scale
Subjective Response - Craving for Alcohol	Placebo - Asn40Asn	BrAC = 0.04 g/dl	2.3095	Standard Deviation 1.4499	score on a scale
Subjective Response - Craving for Alcohol	Placebo - Asn40Asp/Asp40Asp	BrAC = 0.04 g/dl	2.2645	Standard Deviation 1.2311	score on a scale
Subjective Response - Craving for Alcohol	Naltrexone - Asn40Asn	BrAc = 0.06 g/dl	2.0185	Standard Deviation 1.3590	score on a scale
Subjective Response - Craving for Alcohol	Naltrexone - Asn40Asp/Asp40Asp	BrAc = 0.06 g/dl	2.2014	Standard Deviation 1.3430	score on a scale

1 to 10 of 52Source ClinicalTrials.gov

See all 52 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Allocation 1 (First Set of Medication)	STARTED	Allocated to Naltrexone	46
Allocation 1 (First Set of Medication)	STARTED	Allocated to Placebo	41
Allocation 1 (First Set of Medication)	COMPLETED	Allocated to Naltrexone	38
Allocation 1 (First Set of Medication)	COMPLETED	Allocated to Placebo	39
Allocation 1 (First Set of Medication)	NOT COMPLETED	Allocated to Naltrexone	8
Allocation 1 (First Set of Medication)	NOT COMPLETED	Allocated to Placebo	2
Allocation 2 (Second Set of Medication)	STARTED	Allocated to Naltrexone	38
Allocation 2 (Second Set of Medication)	STARTED	Allocated to Placebo	37
Allocation 2 (Second Set of Medication)	COMPLETED	Allocated to Naltrexone	37
Allocation 2 (Second Set of Medication)	COMPLETED	Allocated to Placebo	35

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events48

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Abdominal pain or cramps	Gastrointestinal disorders	Naltrexone	5	75
other	Abdominal pain or cramps	Gastrointestinal disorders	Sugar Pill	4	74
other	Yellow Eyes	Eye disorders	Naltrexone	0	75
other	Yellow Eyes	Eye disorders	Sugar Pill	0	74
other	Nausea or vomiting	Gastrointestinal disorders	Naltrexone	8	75
other	Nausea or vomiting	Gastrointestinal disorders	Sugar Pill	2	74
other	Irritability or anger	General disorders	Naltrexone	7	75
other	Irritability or anger	General disorders	Sugar Pill	0	74
other	Increased desire for sex	General disorders	Naltrexone	4	75
other	Increased desire for sex	General disorders	Sugar Pill	3	74

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Naltrexone	0	75
Total, all-cause mortality	Sugar Pill	0	74
Total, other adverse events	Naltrexone	35	75
Total, other adverse events	Sugar Pill	22	74
Total, serious adverse events	Naltrexone	0	75
Total, serious adverse events	Sugar Pill	0	74

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
21900886	BACKGROUND

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01AA021744	Optimizing naltrexone for individuals of East Asian descent	RAY, LARA A.	UNIVERSITY OF CALIFORNIA LOS ANGELES	NATIONAL INSTITUTE ON ALCOHOL ABUSE AND ALCOHOLISM	2013 to 2015

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Naltrexone vs Sugar Pill: deaths from any cause	Trial comparisons
Naltrexone vs Sugar Pill: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02026011

GET https://conductscience.org/api/trials/v1/NCT02026011/results?page=2

API reference For AI assistants