Trial record 6 of 6 for:    Open Studies | "Asian Americans"

Naltrexone for Individuals of East Asian Descent

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by University of California, Los Angeles
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Lara Ray, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02026011
First received: December 30, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Alcohol Use Disorder
Drug: Naltrexone
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Naltrexone for Individuals of East Asian Descent

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Subjective Effects of Alcohol [ Time Frame: During the alcohol administration and observation period which is expected to last a total of 4 hours ] [ Designated as safety issue: No ]
    Biphasic Alcohol Effects Scale (BAES) Alcohol Urge Questionnaire (AUQ)

  • Neural response to alcohol cues [ Time Frame: During the alcohol cue exposure fMRI paradigm which is expected to last 45 minutes ] [ Designated as safety issue: No ]
    Alcohol taste cues task for fMRI


Secondary Outcome Measures:
  • Alcohol self-administration [ Time Frame: Alcohol self-administration period will last 2 hours ] [ Designated as safety issue: No ]
    Time to first drink and total number of drinks are the primary outcome variables for the alcohol self-administration task


Estimated Enrollment: 90
Study Start Date: December 2013
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Naltrexone
Naltrexone 50 mg/day
Drug: Naltrexone
Naltrexone is an opioid receptor antagonist with highest affinity for mu opioid receptors
Other Names:
  • Revia
  • Depade
  • Vivitrol
Placebo Comparator: Sugar pill
Matched placebo
Drug: Placebo
Sugar pill, matched to the active study medication in capsule size and color
Other Name: Sugar pill

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.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02026011

Contacts
Contact: Katy Lunny, BA 310-206-6756 raylab@psych.ucla.edu
Contact: Taylor Rohrbaugh, BA 310-206-6756 raylab@psych.ucla.edu

Locations
United States, California
UCLA Addictions Laboratory Recruiting
Los Angeles, California, United States, 90095
Contact: Katy Lunny, BA    310-206-6756    raylab@psych.ucla.edu   
Contact: Taylor Rohrbaugh, BA    310-206-6756    raylab@psych.ucla.edu   
Principal Investigator: Lara Ray, PhD         
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: Lara Ray, PhD University of California, Los Angeles
  More Information

Additional Information:
Publications:
Responsible Party: Lara Ray, Associate Professor, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02026011     History of Changes
Other Study ID Numbers: NTX-AA, R01AA021744
Study First Received: December 30, 2013
Last Updated: December 30, 2013
Health Authority: United States: University of California Los Angeles
United States: National Institute on Alcohol Abuse and Alcoholism

Keywords provided by University of California, Los Angeles:
alcohol use disorder
naltrexone
Asian American
pharmacogenetics
OPRM1 gene

Additional relevant MeSH terms:
Alcohol Drinking
Drinking Behavior
Naltrexone
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014