NCT00831272

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2009

Longer than P75 for phase_4

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 5, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 28, 2009

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2013

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2014

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

May 11, 2017

Completed
Last Updated

May 11, 2017

Status Verified

March 1, 2017

Enrollment Period

5 years

First QC Date

January 26, 2009

Results QC Date

January 16, 2017

Last Update Submit

March 29, 2017

Conditions

Alcohol Dependence

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 weeks

Study Arms (2)

Naltrexone

EXPERIMENTAL

50mg/day of naltrexone

Drug: naltrexone

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

naltrexoneDRUG

50mg/day

Also known as: ReVia
Naltrexone
PlaceboDRUG

Placebo

Also known as: sugar pill
Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participant is male or female, 18 years of age or older, and of European or Asian descent.
  • Participant has a current DSM-IV diagnosis of alcohol dependence using the SCID/MINI.
  • The participant has signed a witnessed informed consent form.
  • Participant meets the following drinking criteria as measured by the Timeline Follow Back (TLFB): a. Drinks at least an average of 21 drinks/wk in the 60-day period prior to intake and b. Has 2 or more days of heavy drinking (defined as 5 or more drinks per day in males, 4 or more in females) in this same pre-treatment period.
  • Participant has at least 48 hours of abstinence, as determined by subject report and breathalyzer measure immediately prior to randomization.
  • Participant scores below 8 on the Clinical Inventory of Withdrawal from Alcohol (CIWA) prior to starting Naltrexone.
  • Participant has adequate vision, hearing and ability to communicate to allow study participation.
  • Participant is able to speak, print and understand English.

You may not qualify if:

  • Participant meets DSM-IV criteria for dependence on any substance other than alcohol or nicotine in the last 6 months.
  • Participant has tested positive on the urine drug screen for opioids, benzodiazepines, or cocaine at the screening visit. Presence of THC is allowable.
  • Participant has a current or lifetime DSM-IV diagnosis of bipolar affective disorder, schizophrenia, or any psychotic disorder.
  • Participant has presence of unstable or serious medical illness such as a recent stroke, idiopathic seizure disorder, or cardiac disease.
  • Participant has severe liver disease (SGPT (ALT) or SGOT (AST) of at least 3 times normal value at the time of randomization or an elevated Total Bilirubin level without evidence of Gilbert's Syndrome.
  • Participant has taken any psychotropic medications (including disulfiram) regularly within the last seven days (14 for fluoxetine) prior to randomization or needs immediate treatment with a psychotropic medication (antidepressant, antipsychotic, benzodiazepine, or mood stabilizing medication). EXCEPTIONS: Zolpidem and ramelteon used sparingly if necessary for sleep; Oxazepam for alcohol detoxification; Seizure disorder medications.
  • Participant is over the age of 64 and has evidence of severe cognitive impairment as evidenced by a Mini-mental status exam (MMSE) score \< 24.
  • Participant meets DSM-IV criteria for current major depression (non-substance induced), PTSD, or panic disorder.
  • Participant has suicidal or homicidal ideation necessitating inpatient hospitalization.
  • Participant is a pre-menopausal female who is pregnant, nursing, or not using a reliable method of contraception.
  • Participant is over age 64 and has evidence of severe cognitive impairment as evidenced by a Mini-mental status exam (MMSE) score less than 20.12. Participant is of African descent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Philadelphia VA Medical Center

Philadelphia, Pennsylvania, 19104, United States

Location

University of Pennsylvania Treatment Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15206, United States

Location

Related Publications (1)

  • Oslin DW, Leong SH, Lynch KG, Berrettini W, O'Brien CP, Gordon AJ, Rukstalis M. Naltrexone vs Placebo for the Treatment of Alcohol Dependence: A Randomized Clinical Trial. JAMA Psychiatry. 2015 May;72(5):430-7. doi: 10.1001/jamapsychiatry.2014.3053.

    PMID: 25760804RESULT

MeSH Terms

Conditions

Alcoholism

Interventions

NaltrexoneSugars

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

NaloxoneMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsCarbohydrates

Limitations and Caveats

While the study did not achieve the intended sample size, it is highly unlikely that a larger sample would have resulted in the demonstration of the expected moderating effect of the Asp40 allele.

Results Point of Contact

Title
David Oslin
Organization
University of Pennsylvania
oslin@upenn.edu
215 823 5894

Study Officials

  • David Oslin, MD

    University of Pennsylvania/ Philadelphia VA Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

January 26, 2009

First Posted

January 28, 2009

Study Start

January 5, 2009

Primary Completion

December 20, 2013

Study Completion

January 15, 2014

Last Updated

May 11, 2017

Results First Posted

May 11, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

US(4)