Phase 2
N=87
Naltrexone for Individuals of East Asian Descent
Alcohol Use Disorder
Bottom Line
View on ClinicalTrials.gov: NCT02026011 ↗Enrolled (actual)
87
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Subjective Response - Craving for Alcohol — 1.7037; 1.9965; 2.1012; 1.8478 score on a scale — p=0.39
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Naltrexone (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Sep 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Response - Craving for Alcohol |
1.7037; 1.9965; 2.1012; 1.8478; 1.9198; 2.1319 | 0.39 |
| PRIMARY Subjective Response - Stimulation |
2.0423; 2.0893; 2.0102; 1.8106; 2.2963; 2.7679 | 0.23 |
| PRIMARY Subjective Response - Sedation |
2.6825; 2.3482; 2.1480; 2.0560; 2.8571; 2.8601 | 0.55 |
| PRIMARY Neural Response to Alcohol Cues |
1.48; 8.07; .53; 1.03; .12; 4.43 | — |
| SECONDARY Alcohol Self-administration - Number of Drinks |
1.4444; 0.6458; 1.5714; 0.9565 | 0.14 |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT02026011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.