Naltrexone for Individuals of East Asian Descent

NCT02026011 | Completed Phase 2 Results DMC

• 2 other identifiers: NTX-AAR01AA021744
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Use Disorder

Keywords

alcohol use disorder; naltrexone; Asian American; pharmacogenetics; OPRM1 gene

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

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

Secondary Outcomes (1)

• Alcohol Self-administration - Number of Drinks

  Alcohol self-administration period was 1 hour long

Study Arms (2)

Naltrexone

EXPERIMENTAL

Naltrexone 50 mg/day

Drug: Naltrexone

Sugar pill

PLACEBO COMPARATOR

Matched placebo

Drug: Placebo

Interventions

Naltrexone DRUG

Naltrexone is an opioid receptor antagonist with highest affinity for mu opioid receptors

Also known as: Revia, Depade, Vivitrol

Naltrexone

Placebo DRUG

Sugar pill, matched to the active study medication in capsule size and color

Also known as: Sugar pill

Sugar pill

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Los Angeles: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

UCLA Addictions Laboratory

Los Angeles, California, 90095, United States

Location

Related Publications (1)

• 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.

  PMID: 21900886 BACKGROUND

Related Links

• UCLA Addictions Laboratory

MeSH Terms

Conditions

Alcoholism

Interventions

Naltrexone; vivitrol; Sugars

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Naloxone; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Carbohydrates

Results Point of Contact

• Title: Lara Ray
• Organization: University of California, Los Angeles

lararay@psych.ucla.edu

310-794-5383

Study Officials

• Lara Ray, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 30, 2013
• First Posted: January 1, 2014
• Study Start: December 1, 2013
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: July 17, 2019
• Results First Posted: July 17, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)