drugset / Trial / NCT00831272
Pharmacogenetic Response to Naltrexone For Alcohol Dependence
Phase 4
Completed
221 enrolled
David Oslin
National Institute on Alcohol Abuse and Alcoholism (NIAAA) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The aims of the study are to test for treatment outcome differences in alcohol dependent subjects randomly assigned to 12 weeks of treatment with NTX (50mg/day) or placebo among those with one or two copies of the Asp40 allele of the mu-opioid receptor compared to those homozygous for the Asn40 allele. Thus, the design of the study is a 2X2 cell double-blind randomization to NTX or placebo stratified by genotype. To meet these aims, 150 alcohol dependent outpatients with one or two copies of the Asp40 variant of the mu-opioid receptor and 190 subjects homozygous for the Asn40 variant will be recruited across the four participating sites.
Timeline
- Start
- 2009-01-05
- Primary completion
- 2013-12-20
- Completion
- 2014-01-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Naltrexone | Small molecule | 50 mg | — |