NCT00120601

Brief Summary

The purpose of this study is to compare the effectiveness of two anti-craving medications, naltrexone versus acamprosate, in the treatment of alcohol dependence.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2003

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2003

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 11, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 18, 2005

Completed
Last Updated

July 18, 2005

Status Verified

June 1, 2005

First QC Date

July 11, 2005

Last Update Submit

July 15, 2005

Conditions

Alcoholism

Keywords

treatmentalcoholdependencemedication

Outcome Measures

Primary Outcomes (5)

  • Time (days) to relapse

  • Time (days) to lapse

  • Days abstinence

  • Drinks per drinking day

  • Biochemical measures of liver function

Secondary Outcomes (6)

  • Craving

  • Depression

  • Anxiety

  • Stress

  • Global physical health

  • +1 more secondary outcomes

Interventions

NaltrexoneDRUG
AcamprosateDRUG

Eligibility Criteria

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

You may qualify if:

  • Alcohol dependence according to the ICD10 criteria, with alcohol as the subject's drug of choice
  • Ages 18-65
  • Adequate cognition and English language skills to give valid consent and complete research interviews (as assessed by MMSE)
  • Willingness to give written informed consent
  • Abstinence from alcohol for between 3 and 21 days, and resolution of any clinically evident alcohol withdrawal

You may not qualify if:

  • Opiate abuse within the last one month
  • Sensitivity to study medications or therapy with these drugs within 6 months
  • Active major psychiatric disorder associated with psychosis or significant suicide risk
  • Pregnancy or lactation
  • Advanced decompensated liver disease (hepatocellular failure, variceal bleeding, ascites or encephalopathy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drug Health Services, Royal Prince Alfred Hospital

Sydney, New South Wales, 2050, Australia

Location

Related Links

MeSH Terms

Conditions

Alcoholism

Interventions

NaltrexoneAcamprosate

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 CompoundsTaurineAlkanesulfonic AcidsAlkanesHydrocarbons, AcyclicHydrocarbonsOrganic ChemicalsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Paul Haber, MBBAMDFRACP

    Conjoint Associate Professor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 11, 2005

First Posted

July 18, 2005

Study Start

March 1, 2003

Study Completion

June 1, 2005

Last Updated

July 18, 2005

Record last verified: 2005-06

Locations

AU(1)