NCT00831272

Pharmacogenetic Response to Naltrexone For Alcohol Dependence

Completed Phase 4 Results posted Last updated 11 May 2017

What this trial tests

Phase 4 trial testing naltrexone in Alcohol Dependence in 221 participants. Completed in 15 January 2014.

Timeline

5 January 2009

Primary endpoint
20 December 2013

15 January 2014

Quick facts

Lead sponsor	David Oslin
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	221
Start date	5 January 2009
Primary completion	20 December 2013
Estimated completion	15 January 2014
Sites	4 locations across United States

Drugs / interventions tested

• naltrexone — full drug profile →
• Placebo

Conditions studied

• Alcohol Dependence — all drugs for Alcohol Dependence →

Sponsor

David Oslin

Who can join

18 and older, any sex, with Alcohol Dependence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Clinical Response to Naltrexone, as Measured by a Reduction in the Percent Days of Heavy Drinking Days (as Defined by >5 Drinks/Day for Males; >4 for Females) During the 12 Weeks of the Trial. Primary · 12 weeks

Group	Value	95% CI
Naltrexone Group ASP 40 Group	18.9	± 21.7
Placebo Group ASP 40 Group	17.9	± 21.8
Naltrexone Group ASN 40 Group	14.5	± 19.0
Placebo Group ASN 40 Group	21.7	± 25.7

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were ascertained weekly.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Naltrexone Group ASP 40 Group

Serious: 0/38 (0%)

Deaths: —

Placebo Group ASP 40 Group

Serious: 2/44 (5%)

Deaths: —

Naltrexone Group ASN 40 Group

Serious: 1/73 (1%)

Deaths: —

Placebo Group ASN 40 Group

Serious: 2/66 (3%)

Deaths: —

Serious adverse events (3 terms)

Reaction	System	Naltrexone Group ASP 40 Gr…	Placebo Group ASP 40 Group	Naltrexone Group ASN 40 Gr…	Placebo Group ASN 40 Group
inpatient detoxification	Psychiatric disorders	—	—	—	—
Suicide Attempt	Psychiatric disorders	—	—	—	—
Hospitlized	Endocrine disorders	—	—	—	—

Other adverse events (6 terms — click to expand)

Reaction	System	Naltrexone Group ASP 40 Gr…	Placebo Group ASP 40 Group	Naltrexone Group ASN 40 Gr…	Placebo Group ASN 40 Group
GI complaints	Gastrointestinal disorders	—	—	—	—
Pain	Psychiatric disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Change in libido	Reproductive system and breast disorders	—	—	—	—
Headache	Psychiatric disorders	—	—	—	—
Sleep	Psychiatric disorders	—	—	—	—

Most-reported serious reactions: inpatient detoxification, Suicide Attempt, Hospitlized.

Data from ClinicalTrials.gov NCT00831272 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Naltrexone vs Placebo for the Treatment of Alcohol Dependence: A Randomized Clinical Trial.
   Oslin DW, Leong SH, Lynch KG, Berrettini W, et al · · 2015 · cited 85× · PMID 25760804 · DOI 10.1001/jamapsychiatry.2014.3053
2. Pharmacogenetically driven treatments for alcoholism: are we there yet?
   Arias AJ, Sewell RA. · · 2012 · cited 12× · PMID 22587755 · DOI 10.2165/11633180-000000000-00000