Alcohol Use DisorderPhase 2NCT02026011

Naltrexone for Individuals of East Asian Descent

A Phase 2 study testing Naltrexone in people with Alcohol Use Disorder, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will elucidate the pharmacogenetic effects of the Asn40Asp SNP of the OPRM1 gene on biobehavioral and neural markers of response to naltrexone in individuals of East Asian descent, an ethnic group most likely to express the positive predictive allele. Read more about this study

Who is it for?: Ages 21 to 65 years
Conditions the study is for: Alcohol Use Disorder
What is being tested?: Naltrexone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 87 participants
Where: 1 siteUnited States
Study dates: Dec 2013to Sep 2016
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

current (i.e., past month) alcohol dependence
East Asian ethnicity (i.e., Chinese, Korean, or Japanese)
Prospective genotyping for the A118G SNP of the mu opioid receptor (OPRM1) gene to allow for balanced groups on all three genotypes (AA, AG, GG)

Who cannot join

lifetime DSM-IV of drug dependence (other than alcohol or nicotine)
current use of psychoactive drugs as determined by self-reports and verified using toxicology testing
lifetime diagnosis of bipolar disorder or any psychotic disorder
contraindications to an MRI scan (including left handedness)

Trial locations and contacts

1 site in 1 country.

United States1 site

UCLA Addictions Laboratory
Los Angeles, California, 90095

Other trials in United States

About this study

Official title: Optimizing Naltrexone for Individuals of East Asian Descent

Read the detailed description

Recent pharmacogenetic studies have advanced the gene coding for µ-opioid receptors (OPRM1) gene as a potential moderator of responses to naltrexone. The most widely studied polymorphism of the OPRM1 gene is the Asn40Asp single nucleotide polymorphism (SNP), a functional mutation thought to affect receptor activity such that the Asp40 variant binds β-endorphin three times stronger than the Asn40 allele. Recent studies have found that Asp40 carriers have a stronger striatal dopamine response to intravenous alcohol administration and report stronger feelings of alcohol reward. Findings from the COMBINE Study demonstrated that if treated with Medication Management alone and naltrexone, 87.1% of Asp40 carriers had a good clinical outcome, compared with only 54.8% of Asn40 homozygotes. While these findings are promising, studies have also highlighted allele frequency imbalance as a function of ethnicity such that the Asp40 allele frequency is approximately 20% in Caucasians, 5% in individuals of African Ancestry, and as high as 50% among individuals of East Asian descent. Therefore, to the extent to which this SNP moderates behavioral and clinical responses to NTX, ethnicity must be carefully considered in order to extend the findings from primarily Caucasian samples to ethnic minorities, such as Asian Americans. Preliminary work by our team has found that among individuals of East Asian descent, Asp40 carriers show greater NTX-induced blunting of alcohol craving as well as potentiation of the aversive effects of alcohol. This pilot study also found support for a gene dose-response, such that Asp40Asp individuals showed greater NTX responsivity than those with the Asn40Asp genotype. This study seeks to build upon these preliminary findings by testing heavy drinkers of East Asian descent across three OPRM1 genotypes (Asn40Asn, n = 30; Asn40Asp, n = 30, and Asp40Asp, n = 30). Participants will complete two double-blinded, counterbalanced alcohol infusion and self-administration sessions, one after taking NTX (50 mg/day) and one after taking matched placebo for five days. In each medication condition, participants will complete a functional neuroimaging task examining cue-induced craving for alcohol. This study will elucidate the pharmacogenetic effects of the Asn40Asp SNP of the OPRM1 gene on biobehavioral and neural markers of response to naltrexone in individuals of Asian descent, an ethnic group most likely to express the positive predictive allele (Asp40). The long-term objective of this research is to optimize alcoholism pharmacotherapy and to address health disparities by advancing pharmacogenetic studies in ethnic minority groups.

Conditions: Alcohol Use Disorder
Being tested: Naltrexone, Placebo
Keywords: alcohol use disorder, naltrexone, Asian American, pharmacogenetics, OPRM1 gene
Medical subject headings: Alcoholism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NaltrexoneDrug
Also called Revia, Depade, Vivitrol
Naltrexone is an opioid receptor antagonist with highest affinity for mu opioid receptors
PlaceboDrug
Also called Sugar pill
Sugar pill, matched to the active study medication in capsule size and color

Study groups in NCT02026011
Study group	Role	What they receive
Naltrexone	Experimental	Naltrexone 50 mg/day Receives: Drug: Naltrexone
Sugar pill	Placebo comparator	Matched placebo Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Subjective Response - Craving for Alcohol
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.
Measured: The AUQ was administered across a period of approximately 1.5 hours.
Subjective Response - Stimulation
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.
Measured: 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
Subjective Response - Sedation
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.
Measured: 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
Neural Response to Alcohol Cues
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.
Measured: During the alcohol cue exposure fMRI paradigm which is expected to last 45 minutes

Secondary outcomes (1)

Alcohol Self-administration - Number of Drinks
Total number of drinks consumed during the alcohol self-administration task
Measured: Alcohol self-administration period was 1 hour long

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013Sep 2016

First posted1 Jan 2014 (estimated)
Study startDec 2013
Primary completionSep 2016
Study completionSep 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
More trials run by University of California, Los AngelesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 87 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02026011
Sponsor's protocol ID: NTX-AA
Other IDs: R01AA021744
Status last verified: Jun 2019
First submitted: 30 Dec 2013
Last updated: 17 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No

Publications

Ray LA, Bujarski S, Chin PF, Miotto K. Pharmacogenetics of naltrexone in asian americans: a randomized placebo-controlled laboratory study. Neuropsychopharmacology. 2012 Jan;37(2):445-55. doi: 10.1038/npp.2011.192. Epub 2011 Sep 7.
PubMed 21900886

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alcohol Use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Optimizing Naltrexone for Individuals of East Asian Descent
ClinicalTrials.gov ID: NCT02026011
Acronym / sponsor ID: NTX-AA
Conditions: Alcohol Use Disorder
Keywords: alcohol use disorder, naltrexone, Asian American, pharmacogenetics, OPRM1 gene
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 87 participants (actual)
Lead sponsor: University of California, Los AngelesUniversity, hospital or other
Collaborators: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Study start: Dec 2013
Primary completion: Sep 2016 (actual)
Study completion: Sep 2016 (actual)
First posted: 1 Jan 2014 (estimated)
Results: Posted 17 Jul 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Naltrexone	Experimental	Drug: NaltrexoneNaltrexone 50 mg/day
Sugar pill	Placebo comparator	Drug: PlaceboMatched placebo

Who may qualify

Ages: 21 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

current (i.e., past month) alcohol dependence
East Asian ethnicity (i.e., Chinese, Korean, or Japanese)
Prospective genotyping for the A118G SNP of the mu opioid receptor (OPRM1) gene to allow for balanced groups on all three genotypes (AA, AG, GG)

Key exclusion criteria (4 listed)

lifetime DSM-IV of drug dependence (other than alcohol or nicotine)
current use of psychoactive drugs as determined by self-reports and verified using toxicology testing
lifetime diagnosis of bipolar disorder or any psychotic disorder
contraindications to an MRI scan (including left handedness)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NaltrexoneAlso: Revia, Depade, VivitrolNaltrexone is an opioid receptor antagonist with highest affinity for mu opioid receptors	Drug	Naltrexone
PlaceboAlso: Sugar pillSugar pill, matched to the active study medication in capsule size and color	Drug	Sugar pill

Primary outcome

Subjective Response - Craving for Alcohol
Time frame: 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.
Subjective Response - Stimulation
Time frame: 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.
Subjective Response - Sedation
Time frame: 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.
Neural Response to Alcohol Cues
Time frame: 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.

1 secondary outcome

Alcohol Self-administration - Number of Drinks
Time frame: Alcohol self-administration period was 1 hour long

Results and safety

Results posted to the registry on 17 Jul 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Allocated to Naltrexone	46	38
Allocated to Placebo	41	39

Primary outcome: Subjective Response - Craving for Alcohol

Time frame: The AUQ was administered across a period of approximately 1.5 hours.. Mean (Standard Deviation). Unit: score on a scale

Measure	Naltrexone - Asn40Asn n = 27	Naltrexone - Asn40Asp/Asp40Asp n = 48	Placebo - Asn40Asn n = 28	Placebo - Asn40Asp/Asp40Asp n = 46
BrAC = 0.02 g/dl	1.7037 (0.9295)	1.9965 (1.2862)	2.1012 (1.2881)	1.8478 (0.9812)
BrAC = 0.04 g/dl	1.9198 (1.1260)	2.1319 (1.3024)	2.3095 (1.4499)	2.2645 (1.2311)
BrAc = 0.06 g/dl	2.0185 (1.3590)	2.2014 (1.3430)	2.3095 (1.4400)	2.4891 (1.4595)

Naltrexone - Asn40Asn vs Naltrexone - Asn40Asp/Asp40Asp vs Placebo - Asn40Asn vs Placebo - Asn40Asp/Asp40Asp: p = 0.39, Mixed Models Analysis
Naltrexone - Asn40Asn vs Naltrexone - Asn40Asp/Asp40Asp vs Placebo - Asn40Asn vs Placebo - Asn40Asp/Asp40Asp: p = 0.34, Mixed Models Analysis
Naltrexone - Asn40Asn vs Naltrexone - Asn40Asp/Asp40Asp vs Placebo - Asn40Asn vs Placebo - Asn40Asp/Asp40Asp: p = 0.04, Mixed Models Analysis

Population analysed: Participants who completed at least one experimental session.

Primary outcome: Subjective Response - Stimulation

Time frame: 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. Mean (Standard Deviation). Unit: score on a scale

Measure	Naltrexone - Asn40Asn n = 27	Naltrexone - Asn40Asp/Asp40Asp n = 48	Placebo - Asn40Asn n = 28	Placebo - Asn40Asp/Asp40Asp n = 46
BrAC = 0.02 g/dl	2.0423 (1.7338)	2.0893 (1.8291)	2.0102 (1.9867)	1.8106 (1.7512)
BrAC = 0.04 g/dl	2.2963 (1.8860)	2.7679 (1.9415)	2.3316 (2.0949)	2.4658 (1.9971)
BrAc = 0.06 g/dl	2.8307 (2.3581)	3.0149 (2.1955)	2.2347 (1.9917)	3.0466 (2.4146)

Naltrexone - Asn40Asn vs Naltrexone - Asn40Asp/Asp40Asp vs Placebo - Asn40Asn vs Placebo - Asn40Asp/Asp40Asp: p = 0.23, Mixed Models Analysis
Naltrexone - Asn40Asn vs Naltrexone - Asn40Asp/Asp40Asp vs Placebo - Asn40Asn vs Placebo - Asn40Asp/Asp40Asp: p = 0.09, Mixed Models Analysis
Naltrexone - Asn40Asn vs Naltrexone - Asn40Asp/Asp40Asp vs Placebo - Asn40Asn vs Placebo - Asn40Asp/Asp40Asp: p = 0.84, Mixed Models Analysis

Population analysed: Participants who completed at least one experimental session.

Primary outcome: Subjective Response - Sedation

Time frame: 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. Mean (Standard Deviation). Unit: score on a scale

Measure	Naltrexone - Asn40Asn n = 27	Naltrexone - Asn40Asp/Asp40Asp n = 48	Placebo - Asn40Asn n = 28	Placebo - Asn40Asp/Asp40Asp n = 46
BrAC = 0.02 g/dl	2.6825 (2.1146)	2.3482 (1.6194)	2.1480 (1.6452)	2.0560 (1.6726)
BrAC = 0.04 g/dl	2.8571 (2.1907)	2.8601 (2.0094)	2.4949 (1.7798)	2.6832 (1.8504)
BrAc = 0.06 g/dl	3.0688 (2.4364)	3.1548 (2.0981)	2.6786 (2.4767)	2.4627 (1.8025)

Naltrexone - Asn40Asn vs Naltrexone - Asn40Asp/Asp40Asp vs Placebo - Asn40Asn vs Placebo - Asn40Asp/Asp40Asp: p = 0.55, Mixed Models Analysis
Naltrexone - Asn40Asn vs Naltrexone - Asn40Asp/Asp40Asp vs Placebo - Asn40Asn vs Placebo - Asn40Asp/Asp40Asp: p = 0.77, Mixed Models Analysis
Naltrexone - Asn40Asn vs Naltrexone - Asn40Asp/Asp40Asp vs Placebo - Asn40Asn vs Placebo - Asn40Asp/Asp40Asp: p = 0.04, Mixed Models Analysis

Population analysed: Participants who completed at least one experimental session.

Primary outcome: Neural Response to Alcohol Cues

Time frame: During the alcohol cue exposure fMRI paradigm which is expected to last 45 minutes. Mean (Standard Deviation). Unit: Mean contrast estimate for Alc>Water cue

Measure	Naltrexone - Asn40Asn n = 18	Naltrexone - Asn40Asp/Asp40Asp n = 23	Placebo - Asn40Asn n = 18	Placebo - Asn40Asp/Asp40Asp n = 23
Ventral Striatum	1.48 (19.94)	8.07 (13.95)	.53 (13.47)	1.03 (13.54)
Orbitofrontal cortex	.12 (11.75)	4.43 (9.64)	.45 (7.2)	3.56 (6.95)
Anterior Cingulate cortex	3.31 (17.96)	7.04 (13.90)	5.17 (14.24)	9.49 (13.07)

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Naltrexone	0 of 75 (0%)	35 of 75 (46.7%)	0 of 75
Sugar Pill	0 of 74 (0%)	22 of 74 (29.7%)	0 of 74

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 21900886Ray LA, Bujarski S, Chin PF, Miotto K. Pharmacogenetics of naltrexone in asian americans: a randomized placebo-controlled laboratory study. Neuropsychopharmacology. 2012 Jan;37(2):445-55. doi: 10.1038/npp.2011.192. Epub 2011 Sep 7.
UCLA Addictions LaboratoryLink provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lara Ray, PhD principal investigator

University of California, Los Angeles

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Naltrexone in people with Alcohol Use Disorder, run by University of California, Los Angeles at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Jul 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subjective Response - Craving for Alcohol (time frame: The AUQ was administered across a period of approximately 1.5 hours.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02026011, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.